medicine

Zombies in Hiding Threaten to Trash 2010 Returns: Mark Gilbert

December 9, 2009

Commentary by Mark Gilbert Dec. 10 (Bloomberg) — The journey to global recovery from credit crisis looks to be well under way. Economies from Hong Kong to Germany to the U.S. have popped out of recession. Consumers everywhere seem a bit more confident. Central banks are starting to hint at ways to unhook the financial community from the life support of liquidity and quantitative easing. All that remains, dear investor, is to get through the shopping mall. Unfortunately, the basement is still crawling with zombies, and the chances are that they will find their way out in 2010 while you’re trying to navigate your way to the fields of prosperity. Here are some of the risks you’ll be running next year: Bond Vigilantes Neutered, Rating Companies Search for a Spine Government bailouts mean risk has flowed to public finances from private banks. Increased risk typically means lower ratings and higher borrowing costs — except debt markets are distorted. Central banks are buying their own government’s securities and commercial banks are repairing their balance sheets, to the point where even the most watchful bond vigilante will struggle to punish miscreant borrowers. If the bond market can’t send a message, the rating companies should. Greece got downgraded this week; Standard & Poor’s revised the outlook on Spain’s debt to negative. Bigger, higher-rated countries might be next. Investors may learn the hard way that it isn’t just collateralized debt obligations and structured finance products that can have top AAA credit ratings one day and something lower the next. This week’s statement by Moody’s Investors Service that deteriorating finances in the U.S. and U.K. may “test the Aaa boundaries” should be a reminder that lending to the U.S. government for 10 years at an interest rate of 3.4 percent and to the U.K. for 3.7 percent might not be your smartest trade. All Quasi, No Sovereign The word “quasi” means “kind of; resembling or simulating, but not really the same as, that properly so termed,” according to the Oxford English Dictionary. So in many cases — perhaps all — using the designation “quasi- sovereign” to describe borrowers perceived to be a smidgeon more risky than a country, is about as helpful for assessing creditworthiness as a chocolate teapot is for brewing a hot beverage. That’s the lesson from the Dubai debacle, where lenders are learning that just because a company is state-owned doesn’t mean its bondholders can access the state’s coffers when it’s time for debts to be repaid. “Queasy Non-Sovereigns” might prove to be a better classification for some of that higher-yielding debt you were tempted to buy. The New Normal May Prove Neither New Nor Normal The phrase coined by Pacific Investment Management Co. to describe how it sees the post credit-crunch economy is catching on; even Bank of America Merrill Lynch adopted “The New Normal” as part of the title for its 2010 outlook research report. Conditions, though, are still far from normal, especially with central banks in the U.S., Europe and elsewhere keeping interest rates at record lows in an effort to stimulate borrowing and stoke their economies. The new normal might turn out to be the old business-as-usual: boom-bust economies, bubbles everywhere and a reawakening of the inflation monster. You Can’t Stand Under My Umbrella Anyone hanging on to Greek government debt in the belief that the euro region wouldn’t allow a member state to get into trouble on its debt payments doesn’t understand the Bundesbank. Buy Greece because you think its bonds are cheap, or its stock market has fallen too far, too fast, or because you trust the government to get its finances in order. Do not, though, depend on the euro umbrella to protect your investments; there is no joint and several guarantee among the common currency members and, however destructive a default might be, the precedent of a bailout for fiscal indiscipline would be worse. Securitization’s Snake-Oil Salesmen are Back The financial authorities appear to have missed a golden opportunity to force transparency on the securitization market, where different kinds of debt are bundled together in packages that can be sliced, diced and resold. Central banks have been the only buyers of such debt for months, after the subprime crisis revealed the toxicity of what lay beneath the misguided AAA ratings slapped on many asset- backed securities. As lenders of last resort, the Federal Reserve, the European Central Bank and the Bank of England could have forced the banks they funded to start giving granular detail on every individual loan being securitized. Such strictures would have bathed the market in the antiseptic of sunlight. Instead, yield-hungry investors are again willing to buy bonds without proper access to details about the underlying assets. It’s not too late. Central bankers, though, will have to move swiftly if they want to change the securitization game before it’s too late. Bad Losers The banking fraternity needs to stop moaning about how unfair it is that it can’t award gargantuan bonuses now that the taxpayer has underwritten the global financial system. Such protests only fuel the anger directed against the world of finance. Bankers need to shut up and swallow their medicine, otherwise the nurse is likely to spank them even harder — witness yesterday’s announcement that the U.K. will impose a one-time 50 percent tax on bonuses above about $40,000. Dismissing such measures as populist doesn’t change the basic truth that governments are itching to extract revenge and banks are soft targets. When you’re in a hole, stop digging. ( Mark Gilbert is the London bureau chief and a columnist for Bloomberg News. The opinions expressed are his own.) Click on “Send Comment” in the sidebar display to send a letter to the editor. To contact the writer of this column: Mark Gilbert in London at magilbert@bloomberg.net

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Sickle Cell Breakthrough Allows Marrow Transplants in Adults, Study Finds

December 9, 2009

By Ellen Gibson Dec. 9 (Bloomberg) — Sickle cell disease, which affects 70,000 Americans, was reversed in 9 of 10 patients given bone marrow transplants using a new technique, according to a study that may expand the therapy to adults. People with the disease have misshapen red blood cells. While doctors have long used transplants to replace those cells in children, the treatment has been too toxic for adults. A study in today’s New England Journal of Medicine found that replacing only a portion of the cells can work. Recipients were sickle cell-free 30 months later. None had a common reaction in which immune cells in the donor marrow attack the host’s body. The inherited blood disorder affects 1 in 500 black Americans, causing symptoms that include wheezing, pain, stroke and organ failure, researchers said. The new regimen should be used only when patients can’t be treated in other ways, said Matthew Hsieh, the lead author and a researcher at the National Institutes of Health in Bethesda, Maryland. “Sickle cell is a devastating illness that puts people in and out of hospitals their whole lives,” said Ira Bragg-Grant, executive director of the American Sickle Cell Anemia Association, in Cleveland. “For more adults to be freed of this chronic illness by transplants would be a phenomenal development.” Red blood cells are typically smooth and disk-shaped. In sickle-cell disease, they take the form of a crescent and clump together, causing blockages in the vessels that carry oxygen- rich blood to limbs and organs. A Better Regimen Hsieh and colleagues at the National Institutes primed patients with radiation. To weaken the patients’ immune systems so their bodies wouldn’t reject the incoming cells, the researchers gave them Campath, a drug made by Cambridge, Massachusetts-based Genzyme Corp. that destroys certain white blood cells. Patients received bone marrow containing stem cells, to make healthy red blood cells, from a sibling. After the transplant, the study participants went on an immunosuppressive medication called sirolimus, sold as Rapamune by New York-based Pfizer Inc. ’s Wyeth unit. Hsieh’s goal was to get a favorable mix of donor cells and recipient ones. The study’s results suggest they have the right mix, he said. “Our study is important in two ways,” Hsieh said, “One, we were able to transplant adults and have them be sickle cell- free more than a year later. The other remarkable result was that none of the patients had graft-versus-host disease,” a common complication of bone marrow transplants. More Choices In stem-cell transplantation, the donor’s immune cells sometimes attack the organs in the patient’s body. These reactions are more common in adults than children. The high risk of graft-versus-host disease is one reason Hsieh sought to devise a less-toxic transplant regimen, he said. Currently adult patients with severe sickle cell disease have two treatment choices, said Stuart Orkin, a pediatrics professor at the Harvard Medical School in Boston. The first is hydroxyurea, an anti-tumor drug that is approved for treating pain in sickle cell disease. The problem with hydroxyurea, said Orkin, is that it doesn’t work in all patients. It can also cause infertility. The other is blood transfusions to suppress the production of sickle cells. The trouble is, some people develop iron overload that makes further transfusion impossible. No Cure “Unlike transplantation, these options are purely supportive,” Orkin said. “They don’t cure anything.” While stem-cell transplants are curative, doctors must weigh the risk of infection or even death, said Orkin. They must also consider the amount of existing organ damage and whether it’s reversible, he said. Highly damaged organs can complicate a transplant. On the other hand, people who have had a stroke or organ failure “have more to lose if you don’t act,” said Hsieh, the study author. According to Hsieh, the main drawback of transplantation is that it is hard to find a suitable donor. In his study, he was looking for patients who had siblings with matching white blood cells. Of the 112 eligible patients whose blood type was tested during recruitment, only 24 had qualifying siblings. Furthermore, when doctors go to a bone marrow registry to find compatible donors, it turns out “African Americans are much harder to match because they’re underrepresented,” said Eugene Orringer , a professor of medicine at the University of North Carolina at Chapel Hill. 75,000 Hospitalizations People with sickle cell disease have about 75,000 hospitalizations a year, for a total cost of $475 million, according to data gathered by the National Center for Health Statistics, a U.S. agency. The life expectancy can be as low as 42 years for males who inherit the sickle gene from both parents, according to a study out of the Harvard Medical School. While scientists say that someday soon gene therapy may knock out the disease, transplantation offers the possibility of an immediate cure. At this stage, Hsieh said he is reluctant to use the word “cured” to describe the patients in his study. Still, he is very encouraged by the number of them who are disease-free more than a year after their grafts. Said Hsieh: “We’ve had very good results so far. Our hope is that with more patients and longer follow-up, these patients will remain sickle cell-free.” To contact the reporters on this story: Ellen Gibson in New York at Egibson9@bloomberg.net ;

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Former Tower Analyst Sugihara Leads 17% Gain With Hayate Japan Hedge Fund

December 7, 2009

By Tomoko Yamazaki and Komaki Ito Dec. 8 (Bloomberg) — Yukihiro Sugihara, a former analyst at Tower Investment Management Co. , led his Japan-focused hedge fund to a 17 percent gain this year by concentrating on small companies that escape the attention of analysts and competitors. The 2.4 billion yen ($27 million) Hayate Japan Equity Long- Short Fund invested mainly in companies with a market value of less than 100 billion yen to beat the 0.8 percent gain this year through October in the Jasdaq Stock Index , the nation’s benchmark for smaller companies. Sugihara identifies small companies that are subject to little research by brokerages and are traded primarily by individual investors. The 31-year-old, who has also worked as a proprietary trader at Goldman Sachs Group Inc., then narrows his focus to companies that allow him access to senior management. “Our job is to exploit the gap between what we see in a company and how other people view the stock,” Sugihara, who is chief executive officer of Tokyo-based Hayate Investment Co., said in an interview at his office yesterday. “When people eventually discover the quality that we’ve already found, that’s when prices start to take off.” Hayate Investment aims to increase assets in the fund, whose gain compares with 5.1 percent for the Eurekahedge Japan Hedge Fund Index through November, to 10 billion yen over the next year, Sugihara said. The fund, advised by Hayate Investment, is managed by ManagementPlus (Singapore) Pte. Taiko Pharmaceutical Co. and Foster Electric Co. were among the best performers in 2009 for the fund, whose investment team of two meets more than 1,000 companies each year. Good Medicine Osaka-based Taiko Pharmaceutical, known mainly for its Seirogan diarrhea medication, attracted the fund because Hayate discovered it also owned a patent for a disinfectant product that could help against swine influenza, Sugihara said. The stock has doubled since May when the fund made its investment. The fund had long positions in about 48 stocks and short positions in about 33 as of the end of October. In a short sale, a trader borrows stock and sells it hoping it can be bought back later at a cheaper price. Sugihara said he bet against concerns that Foster, a maker of earphones, would be squeezed by lower-cost Chinese manufacturers when he learnt that the Tokyo-based company was supplying earphones for Apple Inc. ’s iPod and iPhones. In November, Foster more than doubled its full-year net income forecast. The stock has more than tripled this year. Sugihara says he’s now focusing on companies that are providing “outsourcing” businesses such as Askul Corp., which sells office equipment products to medium and small-sized business offices through the Internet and facsimiles. Demographic Trends Companies seeking to profit from rising outsourcing demand as Japan’s population declines are also on the fund manager’s radar, Sugihara said, without identifying specific stocks. The fund has returned more than 20 percent on a net basis since inception in March 2006, after executives at Internet provider Livedoor Co. were charged with fabricating earnings. The scandal sparked concerns about the finances of smaller companies and contributed to a 34 percent slide in the Japanese small-cap market that year, as measured by the Jasdaq. Hayate plans to start a fund next year that will take a more active role in directing management of the small companies it invests in, Sugihara said, declining to elaborate. Hedge funds are private, largely unregulated pools of capital whose managers can buy or sell any assets, bet on falling as well as rising asset prices and participate substantially in profits from money invested. To contact the reporters on this story: Tomoko Yamazaki in Tokyo at tyamazaki@bloomberg.net ; Komaki Ito in Tokyo at kito@bloomberg.net

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Celgene Cancer Pill to Triple Sales on Data That Threaten J&J Dominance

November 30, 2009

By Elizabeth Lopatto Nov. 30 (Bloomberg) — Celgene Corp. can more than triple sales for its best-selling cancer pill Revlimid on new data that may convince doctors to choose the drug as a first option over Johnson & Johnson’s intravenous medicine, Velcade. Revlimid generated $1.3 billion in sales last year as a back-up therapy for patients with the blood cancer multiple myeloma who don’t respond to other options. Findings from research to be reported next week will show how well the pill works as a first-choice treatment, in long-term use and against other tumors. A preliminary report on one study, released in July, suggested Revlimid helped patients live longer. About 20,000 Americans are diagnosed yearly with multiple myeloma, which kills two-thirds of patients within five years, said Kenneth Anderson , a professor at Harvard Medical School in Boston. Broadened use of Revlimid may push annual sales to $4.4 billion by 2016, said Mike King , a Merriman Curhan Ford & Co. analyst in New York, in a telephone interview. Positive results “change the standard of care,” said Anderson, who is an oncologist at Boston’s Dana-Farber Cancer Institute , in a telephone interview. “We treated the very first patients with Revlimid here many years ago. I have patients who have now spent 10 years on Revlimid therapy who are doing quite well. People will be very willing to go onto maintenance therapy” with this drug, he said. Celgene, of Summit, New Jersey, rose 43 cents to $55.06 at 9:57 a.m. in Nasdaq Stock Market composite trading. The stock had increased less than 1 percent in the year before today. J&J, based in New Brunswick, New Jersey, declined 39 cents to $62.50 in New York Stock Exchange composite trading. Bone Marrow Tumors Multiple myeloma causes malignant plasma cells to form tumors, and hinders the body’s ability to fight infections. Revlimid, derived from the drug thalidomide, works by programming cancer cells to commit suicide, and by creating an environment that stalls tumor reproduction. Celgene reported early results in July on the so-called MM- 015 study , designed to show whether using Revlimid and two older cancer therapies helped patients live longer than taking only the other drugs. That report suggested patients may benefit, and that the therapeutic effect was superior to Velcade’s in a similar trial, said Mark Schoenebaum , a Deutsche Bank analyst in New York, in a telephone interview. The MM-015 trial is one of more than 200 involving Celgene to be reported at the American Society of Hematology meeting starting Dec. 5 in New Orleans. Given that Revlimid generated 59 percent of Celgene’s revenue last year, the MM-015 data will be “the first, second, and third act” of the meeting for Celgene, Schoenebaum said. Market Share “The better the data” on that study, Schoenebaum said, “the more market share Revlimid gains.” Convenience will drive increased Revlimid use, because patients will prefer a once-a-day pill to infusions done in a medical office, said Ivan Borrello , an associate professor of oncology at Johns Hopkins University in Baltimore. “Does someone who’s actively working want to go into a doctor’s office twice a week to get Velcade?” Borrello said in a telephone interview. Revlimid was approved in the U.S. in December 2005 for patients with myelodysplastic syndromes, disorders of the blood cells that can lead to leukemia. It was cleared six months later for use as a secondary multiple myeloma therapy. Celgene already has gained about 30 percent of the first- line multiple myeloma market, even though it doesn’t yet have U.S. approval for that use, said Yaron Werber , an analyst with Citigroup Global Markets, in a note to clients this month. Velcade’s share is about 40 percent, Werber said. Velcade Sales Velcade sales surged in 2008 after it won U.S. clearance as a primary treatment for multiple myeloma. J&J, the world’s biggest maker of health products, markets Velcade outside the U.S. and last year reported a 47 percent increase in revenue to $787 million. Japanese drugmaker Takeda Pharmaceutical Co ., of Osaka, sells the medicine in the U.S., where it generated $413.7 million last year, a 43 percent jump, said Lauren Musto , a spokeswoman. The study that helped Velcade win clearance for first-line use in 2008 was a test similar to Celgene’s MM-015 research. Each trial examined whether patients lived longer without their tumors worsening after adding the new drug to a standard regimen of two older therapies, the steroid prednisone and Celgene’s Alkeran, sold generically as melphalan. In the Velcade trial, patients kept cancer at bay an average of eight months longer when the drug was added to the regimen. For that trial, patients were treated for 39 weeks. ‘Big Win’ The Revlimid trial included 30 weeks of therapy or placebo, said King, of Merriman Curhan Ford. “So you tie Velcade? That’s a big win,” King said. “You’re treating for a shorter duration, plus it’s a once-a-day pill rather than a twice-weekly infusion.” J&J declined to comment, referring calls to Takeda. Manisha Pai , a U.S. spokeswoman for Takeda, said in an e- mailed statement that she was “looking forward to interesting data at ASH that examine both the cost and convenience of Velcade compared with oral multiple myeloma therapy options, such as lenalidomide and thalidomide.” Revlimid is designed to be a more potent derivative of thalidomide, first approved in the U.S. in 1998 for leprosy , a progressive skin disease. This family of medicines can also trigger the immune system to fight tumors and hinder growth of blood vessels that nourish them. Thalidomide was linked to severe birth defects, including malformed limbs, in the 1960s and temporarily withdrawn from the market. The drug returned as a potent tumor-fighter, with a warning against use in women who are pregnant. Thalidomide Risks Because multiple myeloma is a difficult-to-diagnose form of cancer, it is often found late, when the benefits of treatment outweigh the risks associated with thalidomide, Harvard’s Anderson said. “Revlimid has made a remarkable difference in terms of the response you can achieve,” Anderson said. “The characteristics that make it attractive are that it’s oral, low dosage, and has few side-effects.” Celgene will also present preliminary results from its test of Revlimid as maintenance therapy at the hematology meeting, with more detailed results to follow in 2010 at the American Society of Clinical Oncology conference. That trial, called IFM-05-02, “has the potential to establish Revlimid as long-term maintenance therapy,” said Geoffrey Porges , an analyst for Sanford C. Berstein & Co. in New York, in a Nov. 11 note to investors. Other Cancers Additional data at the hematology meeting will show how Revlimid works when combined with Velcade and Swiss drugmaker Roche Holding AG’s tumor-fighter Rituxan, approved in non- Hodgkin’s lymphoma and rheumatoid arthritis. Revlimid is also being tested in chronic lymphocytic leukemia, a cancer of the white blood cells, and in so-called smoldering, or aysmptomatic, multiple myeloma. Another study at the hematology meeting will offer the first large human study results for Celgene’s experimental drug pomalidomide, a next-generation product in the same family of medicines as Revlimid. Pomalidomide “is expected to have significantly greater potency,” and “may genuinely have a role in late line multiple myeloma, even in patients who have progressed on prior Revlimid,” Porges said in his note. To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net .

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Celgene Cancer Pill to Triple Sales on New Data Threatening J&J’s Velcade

November 30, 2009

By Elizabeth Lopatto Nov. 30 (Bloomberg) — Celgene Corp. can more than triple sales for its best-selling cancer pill Revlimid on new data that may convince doctors to choose the drug as a first option over Johnson & Johnson’s intravenous medicine, Velcade. Revlimid generated $1.3 billion in sales last year as a back-up therapy for patients with the blood cancer multiple myeloma who don’t respond to other options. Findings from research to be reported next week will show how well the pill works as a first-choice treatment, in long-term use and against other tumors. A preliminary report on one study, released in July, suggested Revlimid helped patients live longer. About 20,000 Americans are diagnosed yearly with multiple myeloma, which kills two-thirds of patients within five years, said Kenneth Anderson , a professor at Harvard Medical School in Boston. Broadened use of Revlimid may push annual sales to $4.4 billion by 2016, said Mike King , a Merriman Curhan Ford & Co. analyst in New York, in a telephone interview. Positive results “change the standard of care,” said Anderson, who is an oncologist at Boston’s Dana-Farber Cancer Institute , in a telephone interview. “We treated the very first patients with Revlimid here many years ago. I have patients who have now spent 10 years on Revlimid therapy who are doing quite well. People will be very willing to go onto maintenance therapy” with this drug, he said. Celgene, of Summit, New Jersey, rose 43 cents to $55.06 at 9:57 a.m. in Nasdaq Stock Market composite trading. The stock had increased less than 1 percent in the year before today. J&J, based in New Brunswick, New Jersey, declined 39 cents to $62.50 in New York Stock Exchange composite trading. Bone Marrow Tumors Multiple myeloma causes malignant plasma cells to form tumors, and hinders the body’s ability to fight infections. Revlimid, derived from the drug thalidomide, works by programming cancer cells to commit suicide, and by creating an environment that stalls tumor reproduction. Celgene reported early results in July on the so-called MM- 015 study , designed to show whether using Revlimid and two older cancer therapies helped patients live longer than taking only the other drugs. That report suggested patients may benefit, and that the therapeutic effect was superior to Velcade’s in a similar trial, said Mark Schoenebaum , a Deutsche Bank analyst in New York, in a telephone interview. The MM-015 trial is one of more than 200 involving Celgene to be reported at the American Society of Hematology meeting starting Dec. 5 in New Orleans. Given that Revlimid generated 59 percent of Celgene’s revenue last year, the MM-015 data will be “the first, second, and third act” of the meeting for Celgene, Schoenebaum said. Market Share “The better the data” on that study, Schoenebaum said, “the more market share Revlimid gains.” Convenience will drive increased Revlimid use, because patients will prefer a once-a-day pill to infusions done in a medical office, said Ivan Borrello , an associate professor of oncology at Johns Hopkins University in Baltimore. “Does someone who’s actively working want to go into a doctor’s office twice a week to get Velcade?” Borrello said in a telephone interview. Revlimid was approved in the U.S. in December 2005 for patients with myelodysplastic syndromes, disorders of the blood cells that can lead to leukemia. It was cleared six months later for use as a secondary multiple myeloma therapy. Celgene already has gained about 30 percent of the first- line multiple myeloma market, even though it doesn’t yet have U.S. approval for that use, said Yaron Werber , an analyst with Citigroup Global Markets, in a note to clients this month. Velcade’s share is about 40 percent, Werber said. Velcade Sales Velcade sales surged in 2008 after it won U.S. clearance as a primary treatment for multiple myeloma. J&J, the world’s biggest maker of health products, markets Velcade outside the U.S. and last year reported a 47 percent increase in revenue to $787 million. Japanese drugmaker Takeda Pharmaceutical Co ., of Osaka, sells the medicine in the U.S., where it generated $413.7 million last year, a 43 percent jump, said Lauren Musto , a spokeswoman. The study that helped Velcade win clearance for first-line use in 2008 was a test similar to Celgene’s MM-015 research. Each trial examined whether patients lived longer without their tumors worsening after adding the new drug to a standard regimen of two older therapies, the steroid prednisone and Celgene’s Alkeran, sold generically as melphalan. In the Velcade trial, patients kept cancer at bay an average of eight months longer when the drug was added to the regimen. For that trial, patients were treated for 39 weeks. ‘Big Win’ The Revlimid trial included 30 weeks of therapy or placebo, said King, of Merriman Curhan Ford. “So you tie Velcade? That’s a big win,” King said. “You’re treating for a shorter duration, plus it’s a once-a-day pill rather than a twice-weekly infusion.” J&J declined to comment, referring calls to Takeda. Manisha Pai , a U.S. spokeswoman for Takeda, said in an e- mailed statement that she was “looking forward to interesting data at ASH that examine both the cost and convenience of Velcade compared with oral multiple myeloma therapy options, such as lenalidomide and thalidomide.” Revlimid is designed to be a more potent derivative of thalidomide, first approved in the U.S. in 1998 for leprosy , a progressive skin disease. This family of medicines can also trigger the immune system to fight tumors and hinder growth of blood vessels that nourish them. Thalidomide was linked to severe birth defects, including malformed limbs, in the 1960s and temporarily withdrawn from the market. The drug returned as a potent tumor-fighter, with a warning against use in women who are pregnant. Thalidomide Risks Because multiple myeloma is a difficult-to-diagnose form of cancer, it is often found late, when the benefits of treatment outweigh the risks associated with thalidomide, Harvard’s Anderson said. “Revlimid has made a remarkable difference in terms of the response you can achieve,” Anderson said. “The characteristics that make it attractive are that it’s oral, low dosage, and has few side-effects.” Celgene will also present preliminary results from its test of Revlimid as maintenance therapy at the hematology meeting, with more detailed results to follow in 2010 at the American Society of Clinical Oncology conference. That trial, called IFM-05-02, “has the potential to establish Revlimid as long-term maintenance therapy,” said Geoffrey Porges , an analyst for Sanford C. Berstein & Co. in New York, in a Nov. 11 note to investors. Other Cancers Additional data at the hematology meeting will show how Revlimid works when combined with Velcade and Swiss drugmaker Roche Holding AG’s tumor-fighter Rituxan, approved in non- Hodgkin’s lymphoma and rheumatoid arthritis. Revlimid is also being tested in chronic lymphocytic leukemia, a cancer of the white blood cells, and in so-called smoldering, or aysmptomatic, multiple myeloma. Another study at the hematology meeting will offer the first large human study results for Celgene’s experimental drug pomalidomide, a next-generation product in the same family of medicines as Revlimid. Pomalidomide “is expected to have significantly greater potency,” and “may genuinely have a role in late line multiple myeloma, even in patients who have progressed on prior Revlimid,” Porges said in his note. To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net .

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Boehringer Drug Increases Women’s Libidos, Frequency of Sex, Studies Show

November 16, 2009

By Naomi Kresge Nov. 16 (Bloomberg) — Boehringer Ingelheim GmbH’s desire pill, taken at bedtime for six months, boosted women’s libidos and led to better sex, according to the first published evidence showing the experimental drug works. Women who took the medicine, known as flibanserin, reported 22 percent more “satisfying sexual events” than those given a placebo in two clinical tests of 1,378 patients, according to abstracts released today at the European Society for Sexual Medicine annual meeting in Lyon, France. The findings show women who took the drug had more sex, wanted more sex and experienced less distress related to lack of desire. Boehringer plans to use the research to seek permission to sell the first female libido drug in the U.S. and Europe, potentially rekindling a debate that began a decade ago with the introduction of Pfizer Inc. ’s Viagra on whether lackluster desire is a legitimate medical condition. “Based on these optimistic and positive findings, we definitely plan to file” for regulatory approval, Michael Sand, director of clinical research at Boehringer and team leader for flibanserin, said in an interview at the meeting. The family-owned drugmaker from Ingelheim, on the Rhine’s west bank, started researching the compound more than a decade ago as a depression drug. Researchers tracked test subjects’ level of sexual appetite in order to check that flibanserin wasn’t hurting their libido and were startled to find the opposite was true for women. With or Without Therapy? The U.S. market for medicines to rekindle female desire could exceed $3.5 billion a year, BioSante Pharmaceuticals Inc. Chief Executive Officer Stephen Simes estimated in an e-mail yesterday. The company is developing a rival therapy, a testosterone gel for menopausal women. Simes says at least $1 billion in revenue could come from women who haven’t reached the age of menopause. If Boehringer’s drug makes it to market, it’s likely to be prescribed along with sex therapy, said Michael Berner , a Freiburg University Hospital psychiatrist whose patients took part in Boehringer’s studies, before the results were released. The pill targets women upset or frustrated by a lack of desire, or whose diminished libidos cause problems in their relationships. The company said today it hopes the drug can be prescribed by itself, not just as a complement to therapy. “It’s perfectly reasonable to expect that clinicians, if flibanserin is approved, will offer this as stand-alone therapy,” Boehringer’s Sand said. No Pill in Bedroom Some researchers and psychologists believe a pill has no place in the bedroom, and that women bothered by a decrease in desire should focus instead on the relationship and social factors that might explain the change. Flibanserin is “not really an enhancement drug, like Viagra is — taken on demand — but a long-term treatment, like steroids,” New York psychologist Leonore Tiefer said by e-mail before the results were released. The compound takes three to six weeks to kick in. Side effects reported in the clinical trials included dizziness, nausea, drowsiness and insomnia. About a third of the women in the study dropped out for a range of reasons, including side effects, Sand said. Study Results The main criterion for the four clinical trials, which the company named after flowers, was how many “satisfying sexual events” women said they had experienced after starting treatment. That can include masturbation. Boehringer recruited more than 5,000 heterosexual, pre-menopausal women who had been with their partners for at least a year to try the pill. Pooled results from 1,378 women in the so-called Daisy and Violet trials in North America showed that women taking 100 milligrams of flibanserin nightly reported an average of 4.5 satisfying sex acts per month, up from 2.8 acts during a four- week test period used to establish a baseline for comparison. Women taking a placebo reported 3.7 satisfying sex acts, compared to 2.7 acts during the baseline period. The women taking flibanserin didn’t just have more sex, but found it more satisfying, Sand said. The company hasn’t ruled out testing the medicine in men, he added. ‘Two Feet on the Brakes’ The Orchid trial in Europe failed to show a statistically significant increase in the number of satisfying sexual events, though women did report greater desire, according to abstracts posted on the conference Web site. The results were significant when pooled with the two North American studies, Boehringer said. A third U.S. trial, Dahlia, showed that a lower dose of the drug didn’t work. Flibanserin works on the brain by putting “two feet on the brakes” to block the release of a chemical called serotonin , which regulates mood, appetite, sleep and memory, said Jim Pfaus, a neurologist at Concordia University in Montreal, who conducted early tests of the drug in rats. In time, the process should trigger the production of dopamine, a chemical that, among other jobs, helps stimulate desire. The drug could be the first success after a series of failures from drugmakers including Procter & Gamble Co. and Pfizer. The New York-based maker of Viagra abandoned efforts to adapt its pill for women in 2004 and closed sex-health research at the end of last year. The world’s largest closely held pharmaceutical company, Boehringer needs new drugs because it faces the loss of 1 billion euros ($1.5 billion) in annual revenue when two older medicines, Mirapex for Parkinson’s disease and Flomax to treat enlarged prostate, lose patent protection next year. To contact the reporter on this story: Naomi Kresge in Lyon at nkresge@bloomberg.net

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Female Desire Drug Sparking Libido May Prove Sex Really Is All in Her Head

November 13, 2009

By Naomi Kresge Nov. 13 (Bloomberg) — Boehringer Ingelheim GmbH is banking on sex really being all in women’s heads. The German drugmaker is putting the finishing touches on a pill designed to reawaken desire by blunting female inhibitions. Unlike Viagra, which targets the mechanics of sex by boosting blood flow to the penis, this drug works on the brain. The desire drug, the focus of a meeting on sexual disorders in Lyon next week, has the potential to revolutionize sexual medicine much as Pfizer Inc. ’s blue pill did a decade ago. That could put family-owned Boehringer at the center of a debate about whether the medicine is a chemical shortcut around a complex dysfunction involving body and mind — or whether disinterest in sex is a legitimate medical condition. “This drug has the potential to finally open the door to acceptance of the idea that decreased desire can be something that involves a dysfunctional way the brain works, and not only a bad partner,” said Jim Pfaus, a neurologist at Concordia University in Montreal, who conducted early tests of the drug in rats. “Of course it’s in your head.” The U.S. market for medicines to rekindle female libido could be bigger than the $2 billion a year in U.S. sales for erectile dysfunction treatments because more women report sexual problems, BioSante Pharmaceuticals Inc. Chief Executive Officer Stephen Simes estimated last year. Showing It Works Boehringer, based in the German town of Ingelheim on the Rhine’s west bank, was searching for a depression treatment in the 1990s when it stumbled on the compound, called flibanserin. By 2002, Boehringer found the drug wasn’t lifting patients’ mood. The company says researchers were startled when test subjects rated one measure of well-being, sexual appetite, consistently higher than the others. After what Pfaus described as an initial period of hesitation about developing a sex pill, Boehringer decided to move forward. The company needs new drugs because it faces the loss of 1 billion euros ($1.5 billion) in annual revenue when two older medicines, Mirapex for Parkinson’s disease and Flomax to treat enlarged prostate, lose patent protection next year. The world’s largest closely held pharmaceutical company has been studying flibanserin for more than a decade and it has yet to publish clinical test results showing the drug is effective. The company will lift its veil of secrecy on Monday at the European Society for Sexual Medicine conference with data from trials of more than 5,000 European and U.S. women. Women’s Distress The main criterion for the clinical trials, which the company named after flowers, was how many “satisfying sexual events” women said they had experienced after starting treatment. If the results are good, the so-called Bouquet studies, dubbed Violet, Daisy, Dahlia and Orchid, could form the basis for applications to U.S. and European regulators. The German company is taking a page from Pfizer’s book. The U.S. drugmaker broadened the appeal of Viagra in 1998 by steering clear of the word “impotence” and saying the blue pill addressed a disease called erectile dysfunction. Boehringer is avoiding potentially offensive words such as frigidity and refers to the problem its pill cures by its clinical name, hypoactive sexual desire disorder , or HSDD. “An increasing body of evidence shows that hypoactive sexual desire disorder causes substantial emotional distress,” said Heike Specht, a spokesman for the company. The drugmaker “has conducted late-stage clinical trials in over 5,000 women from which we hope will result the first available pharmaceutical treatment.” A Boehringer survey of 31,000 U.S. women aged 18 and above found that one in 10 expressed distress because of diminished sex drive. Ideological Battle A sluggish libido is “a real problem,” and early clinical results so far suggest Boehringer’s drug can help, according to Stephen Stahl , a psychopharmacologist and chairman of the Neuroscience Education Institute in Carlsbad, California. Stahl, who has been a consultant for Boehringer, sees a growing role for drugs in treating sexual disorders. Not everyone agrees there is a disorder to begin with. In 2003, a year after Boehringer started the Bouquet clinical trials, an article written by Ray Moynihan in the British Medical Journal called female sexual dysfunction “the freshest, clearest example we have” of a disease created by pharmaceutical companies to make healthy people think they need medicine. “This is for some an ideological battle,” said psychiatrist Michael Berner of the Freiburg University Clinic , who had patients in Boehringer’s studies. “One view is the multi-dimensional view you get from people like me. And then you have these people that say you should work only on relationship issues and that medication cannot have a place.” ‘Like Dancing’ Researchers don’t know why some women’s libido falters, said Pfaus, who has tested compounds in rats for Pfizer, Boehringer and Palatin Technologies Inc . by gauging whether they spur female rats to solicit sex from males. “An erection is obvious, it’s easy,” Pfaus said. “But desire — how do you get at that?” The explanation may be partly evolutionary, according to Berner, who says male primates are driven by a need to spread their semen, while for females it’s important to be able to care for and rear the offspring. Some researchers believe the social components of intercourse mean that sexual problems can’t be addressed in the same way as heart failure or cancer. Sex is a “historical and cultural phenomenon,” said Leonore Tiefer, a psychiatry professor at New York University . There’s no baseline of normalcy by which to define a disorder, she contends. “It’s like dancing, or music, or piano-playing,” Tiefer said. “You do it with the body, but the part the body plays isn’t the largest part.” Over the Wall Flibanserin works on the brain by putting “two feet on the brakes” to block the release of a chemical called serotonin , which regulates mood, appetite, sleep and memory, Pfaus said. In time, the process should trigger the production of dopamine, a chemical that, among other jobs, helps stimulate desire. The drug differs from testosterone, a hormone that’s also been tested to reawaken women’s desire. Berner, interviewed at his study in Freiburg, sketched the picture of a wall to explain how flibanserin works. “You’re standing here, sad, inhibited,” he said, drawing a stick figure next to the wall on a scrap of paper. “Testosterone would give you a little bit more excitement, so you’d climb over. Flibanserin would take away one of the stones.” Once a Day The compound takes three to six weeks to kick in. The pill has to be taken daily, and some women taking part in the clinical trials reported feeling tired, Berner said. Boehringer recruited women for clinical studies using print advertisements. Berner said his patients were largely professionals in their early 30s to mid-40s, and most chose to continue in the trial in a subsequent phase that ensured they would get the real drug instead of a placebo. Boehringer is recruiting older women for a follow-up study. Women can be diagnosed with hypoactive sexual desire disorder if they feel concerned, bothered or frustrated by a lack of desire — or if it’s hurting their relationships. The company used personal digital assistants to check whether the pill was working. Participants were beeped once a day and asked to rate their level of desire and say whether they had been sexually active and whether it was enjoyable. Potential Rivals If flibanserin makes it to market, it will be the first success after a series of failures from drugmakers including Procter & Gamble Co. and Pfizer. The New York-based maker of Viagra abandoned efforts to adapt its pill for women in 2004 and closed sex-health research at the end of last year. The only female sexual dysfunction therapy approved in the U.S. is Eros-CTD , from NuGyn, Inc., a suction pump that fits over the clitoris much like the erection pumps that predated Viagra. Intrinsa, a testosterone patch from Noven Pharmaceuticals Inc. licensed by Procter & Gamble, is sold in Europe for women whose uteruses have been removed. A U.S. version was put on hold in 2004 on concern about whether it is safe for long-term use. Still in clinical trials are a new version of the P&G patch; LibiGel, a testosterone gel from BioSante ; and bremelanotide, an injected therapy from Palatin Technologies. Researchers around the world will be watching Boehringer’s results in Lyon, according to Pfaus. “There are probably a lot of companies holding their breath,” he said. To contact the reporter on this story: Naomi Kresge in Zurich at nkresge@bloomberg.net

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Talmadge E. King, Jr. Elected to NCQA Board of Directors

November 9, 2009

WASHINGTON, DC–(Marketwire – November 9, 2009) – The National Committee for Quality Assurance (NCQA) announced today that Talmadge E. King, Jr., M.D., Julius R. Krevans Distinguished Professor and Chair, Department of Medicine, University of California, San Francisco, has been elected to its Board of Directors. Dr. King has a national reputation for his experience concerning the treatment of patients in poor and minority populations living with chronic diseases, and is a leading expert on inflammatory lung injury.

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U.S. Army Psychiatrist in Custody After 13 Killed, 30 Hurt on Texas Base

November 6, 2009

By Viola Gienger and Anthony Capaccio Nov. 6 (Bloomberg) — An Army psychiatrist is under guard in a Texas hospital after being accused of killing 13 people and wounding 30 others in one of the worst mass shootings at a U.S. military base. Major Nidal Malik Hasan opened fire on fellow soldiers with two handguns at the Fort Hood Army Base yesterday afternoon before he was shot several times, Lieutenant General Robert Cone, the commander of III Corps at the base, told reporters. “He is currently in custody and in a stable condition,” said Cone, adding authorities initially believed the assailant had been killed. “As horrible as this was, I think it could have been much worse.” Military officials and the Federal Bureau of Investigation are probing what triggered the attack by the licensed physician at a crowded medical processing center on the base. Senator Kay Bailey Hutchison , a Texas Republican, said she was told by Fort Hood authorities the suspect was about to be deployed to Iraq or Afghanistan and had been “very upset and angry” in the past few days. President Barack Obama called it a “horrific outburst of violence” directed at soldiers who have dedicated their lives to protecting the nation. While the deaths of soldiers in battles overseas is tragic, “it is horrifying that they should come under fire at an Army base on American soil,” Obama said in Washington. Injured Woman Dies The death toll rose to 13 from 12 early today when a woman who was shot died of her injuries, a base spokeswoman said by telephone. The shootings began at about 1:30 p.m. local time as soldiers were awaiting dental and medical treatment at the processing center, said Cone. At an auditorium about 50 meters (164 feet) away, 138 soldiers were graduating from college extension courses and officials were able to close the doors to protect participants, he said. Military police locked down the base after the shooting, lifting the restrictions hours later after determining there was no likelihood of a further threat. The Virginia Board of Medicine lists Hasan as a licensed physician who has a primary practice at the Darnall Army Medical Center at Fort Hood. It says he received his medical degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland, in 2003 and completed a residency in psychiatry at the Walter Reed Army Medical Center in Washington in 2007 and a fellowship in disaster and preventive psychiatry in 2009. Hasan, 39, transferred to Fort Hood in July, the Associated Press reported, citing unidentified military officials. Devout Muslim He was a devout Muslim and had sought for several years to be discharged from the military, the Washington Post reported, citing his aunt. Noel Hasan told the newspaper her nephew had endured name-calling and harassment about his faith for years after the Sept. 11, 2001, attacks on New York and the Pentagon. The Council on American-Islamic Relations condemned the shootings and urged calm as investigators piece together what happened. “No political or religious ideology could ever justify or excuse such wanton and indiscriminate violence,” Nihad Awad , the group’s executive director, said in a statement. Admiral Michael Mullen , chairman of the Joint Chiefs of Staff, said in a statement the Army should be allowed to complete its investigation before “we speculate about the circumstances leading to this senseless violence.” The suspect came to the attention of authorities six months ago because of Internet postings discussing suicide bombings and other threats, AP reported, citing unidentified law enforcement officials. Suicide Bombers One of the Web postings equated suicide bombers with a soldier throwing himself on a grenade to save the lives of his comrades, according to the report. Officials are trying to confirm whether Hasan was the author of the postings, the news service said. FBI agents and police raided Hasan’s apartment early today and were searching for evidence, CNN reported. Fort Hood, about 60 miles (97 kilometers) north of Austin, the Texas capital, houses about 45,000 U.S. troops and is home to the Army’s 1st Calvary and 4th Infantry divisions. It is one of the three largest Army bases in the U.S. by population and acreage. Base Suicides The base has felt the strain of multiple combat deployments, with 10 suicides reported there this year and more than 75 since the U.S.-led invasion of Iraq in 2003, the Washington Post reported. Hasan’s apartment is in the nearby town of Killeen, the site of one of the worst mass killings in U.S. history. A gunman drove his pickup truck through a cafeteria window in 1991 and shot 22 people dead with a handgun before killing himself, AP said. No other shooting at a military base in the U.S. has been anywhere near as deadly as yesterday’s attack, the news service reported. In 1993, a gunman at Fort Knox shot five civilian co- workers, killing three, and then fatally shot himself, AP said. To contact the reporters on this story: Viola Gienger in Washington at vgienger@bloomberg.net ; Anthony Capaccio in Washington at acapaccio@bloomberg.net .

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Antipsychotic Drugs in Kids Linked to Rapid Weight Gain, Research Finds

October 27, 2009

By Nicole Ostrow Oct. 27 (Bloomberg) — Children and teens who took antipsychotic medicines in a study gained weight and developed increased blood-fat levels, possibly harming their future health, researchers in New York State said. The subjects, taking the antipsychotic drugs for the first time, gained from 9.7 to 18.7 pounds (4.4 to 8.5 kilograms) after about 11 weeks of treatment, depending on which medicine they were given, the scientists said today in the Journal of the American Medical Association. Fifteen patients who didn’t stick with drugs or who declined to participate in the research gained less than half a pound on average. The study was the largest to show how antipsychotic medicines affect the bodies of children taking the drugs for the first time, the researchers wrote. Many past studies of the drugs involved patients who had also used other treatments — methodology that may have masked the extent of weight gain, according to an editorial published along with the study. “We were able to show all of these agents can cause quite a bit of body weight changes and body composition changes that are not beneficial to the health,” said Christoph Correll , the study’s lead author, in a telephone interview on Oct. 23. “What we need to figure out is what are the long-term consequences in the lives of children,” Correll, who is a medical director at Zucker Hillside Hospital in New York City’s Queens borough and an associate professor of psychiatry at Yeshiva University’s Albert Einstein College of Medicine in the Bronx. Metabolic Syndrome Gaining weight and changes in blood sugars and fats can be precursors to metabolic syndrome , a group of risk factors linked to heart disease and diabetes, according to the research article. Patients in the study had been diagnosed with mood disorders, schizophrenia and disruptive or aggressive behavior. Their doctors had prescribed Bristol-Myers Squibb Co.’s Abilify, Eli Lilly & Co.’s Zyprexa, AstraZeneca Plc’s Seroquel or Johnson & Johnson’s Risperdal. Risperdal and Abilify are the only two antipsychotics approved for pediatric use. A panel of outside advisers to the U.S. Food and Drug Administration recommended in June that Seroquel, Zyprexa and Pfizer Inc.’s Geodon be cleared for pediatric use. The medicines, so-called atypical antipsychotics, were introduced for adults in the mid-1990s and marketed as having fewer neurological side effects than older drugs. The FDA has grappled with pediatric use for years because of concerns that the weight gain, sleepiness and movement disorders reported as side effects in adults may be more pronounced in children. Sales in Billions U.S. sales of antipsychotic drugs reached $14.6 billion last year, the most for any class of medicines, according to IMS Health Inc. in Norwalk, Connecticut. Use of antipsychotic medicines by people less than 20 years old has more than doubled since 2001, according to data compiled by Medco Health Solutions Inc. of Franklin Lakes, New Jersey. The study reported today was conducted to determine if weight gain and other changes to the body were related to the start of a psychiatric illness or hospital admission, or to the medicines. Researchers at Zucker Hillside, and at the Feinstein Institute for Medical Research in Manhasset, New York, studied 272 people ages four to 19 who were prescribed the antipsychotic medicines for behavioral, mood or psychosis-related problems. The patients were followed for the first 12 weeks. Added Pounds At about 11 weeks, those taking Zyprexa gained 18.7 pounds on average, compared with 13.4 for Seroquel, 11.7 for Risperdal and 9.7 for Abilify, the study showed. “The extent and the rate of weight gain is remarkable,” said Christopher Varley , a professor in the psychiatry and behavioral sciences department at the University of Washington in Seattle, in a telephone interview on Oct. 23. “Realistically the kids were exposed to 11 or 12 weeks of medication. Some of them gained over 20 pounds.” Varley co-wrote the editorial in the journal that was published along with the study. Ten percent to 36 percent of the patients in the study became overweight or obese within 11 weeks of starting the medicine, the researchers said. Those on Zyprexa had larger increases in cholesterol and blood sugars, according to the study. Those on Risperdal had rises in their levels of triglyceride, a type of fat found in the blood, without affecting their blood sugar, the researchers wrote. Those on Seroquel also had an increase in total cholesterol and triglycerides, and patients on Abilify didn’t have any significant worsening in their blood fats or blood sugars, according to the scientists. Monitoring Kids Correll recommended that parents monitor their children’s weight and make sure the kids are eating healthy food and exercising. Doctors in some cases should consider counseling and behavior therapy, as well as parental training, before prescribing the drugs, Correll said. Once the medicines are given to children and adolescents, doctors need to frequently monitor the weight gain and the patients’ blood sugars and blood fats, he said. In the editorial accompanying the study, Varley wrote, “Given the risk for weight gain and long-term risk for cardiovascular and metabolic problems, the widespread and increasing use of atypical antipsychotic medications in children and adolescents should be reconsidered.” The study was funded partly by the U.S. National Institutes of Health, based in Bethesda, Maryland. For Related News and Information: To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net .

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Glaxo Ordered to Pay $2.5 Million in First of 600 Cases Over Paxil Defects

October 13, 2009

By Jef Feeley and Sophia Pearson Oct. 13 (Bloomberg) — GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial. Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug. “The first win is always huge, especially when you get a jury saying the drug caused the injury,” Sean Tracey, the family’s lawyer, said in an interview after the verdict. It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid the risk to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo’s total revenue. The company disagrees with the verdict and will appeal, Kevin Colgan , a spokesman, said in an e-mailed statement. “While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition,” Colgan said. Glaxo’s provision for legal and other nontax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), it said in a July 22 regulatory filing that didn’t mention the Paxil litigation. Heart Defects’ Cause In the Kilker case, jurors found 10-2 that Glaxo officials “negligently failed to warn” the doctor treating Lyam’s mother about Paxil’s risks and concluded the medicine was a “factual cause” of the child’s heart defects. The Philadelphia Common Pleas Court panel also found that Glaxo’s handling of the drug wasn’t “outrageous,” meaning the family couldn’t seek punitive damages against the drugmaker. Glaxo is also fighting suits in the U.S., Canada and the U.K. over claims that Paxil, whose generic name is paroxetine, causes homicidal and suicidal behavior. The company settled some suicide claims, under undisclosed terms. In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement required Glaxo to publicly disclose the studies. In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled while on appeal, according to Colgan, the Glaxo spokesman. The Philadelphia case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia). To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net ; Sophia Pearson in Philadelphia at spearson3@bloomberg.net .

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Lung Failure in Swine-Flu Patients May Spur Life-Support Machine Demand

October 13, 2009

By Jason Gale Oct. 13 (Bloomberg) — Dozens of swine flu patients were saved from respiratory failure when doctors in Australia and New Zealand turned to machines that pump blood through an artificial lung , resulting in a 17-fold increase in the uncommon procedure. The finding, published in the Journal of the American Medical Association yesterday, is based on the first population- wide study of lung-bypass equipment made by companies such as Getinge AB and Medtronic Inc. to treat H1N1 patients. The study suggests the life-saving technique might be used on about 800 cases in the U.S. this winter and 1,300 in the European Union . Sixty-eight patients whose damaged lungs rendered them unable to breathe had the procedure, the authors said. One out of five died and almost half were able to walk out of the hospital after suffering acute respiratory distress syndrome , a condition fatal in up to 48 percent of cases. “We have a gut feeling that these patients would have died more frequently and that we did improve the likelihood of their survival,” said Andrew Davies, deputy director of intensive care at Melbourne’s Alfred Hospital and the study’s lead author. An additional 133 flu patients received mechanical ventilation in which air is blown into the lungs, but not the lung-bypass procedure known as extracorporeal membrane oxygenation or ECMO. The study didn’t include a case-controlled comparison of patient outcomes in both groups, Davies said. Respiratory Distress From June 1 to Aug. 31, the procedure was used in New Zealand and Australia on patients with confirmed or suspected swine flu at a rate of more than 2.6 per million people. In comparison, only four patients with acute respiratory distress syndrome or ARDS received ECMO in the same ICUs the previous winter, an incidence of 0.15 cases per million people. ARDS, a complication of viral pneumonia and other causes of lung injury, is fatal in 30 percent to 48 percent of patients, the authors said. The average age of patients with the new H1N1 strain who received ECMO at 15 intensive care sites in Australia and New Zealand was 34.4 years, the doctors said. At least half of them were overweight or obese, a third suffered from chronic lung disease, 16 percent were pregnant or had recently given birth, and a similar proportion suffered type-2 diabetes, they said. ‘Dreadfully Sick’ “They were dreadfully sick as a bunch when we put them on ECMO, and you would have thought that group of patients would have had a higher mortality,” Davies said in a telephone interview today. As of Sept. 7, 48 of the 68 ECMO patients had been discharged from the intensive care unit, of whom 32 had been discharged from the hospital and 16 were still hospitalized. Fourteen patients had died and six remained in the ICU, two of whom were still receiving ECMO, according to the study. Intensive care specialists in Australia and New Zealand, where swine flu cases peaked in July and August, ordered ECMO systems from companies including Maquet Cardiopulmonary AG , a subsidiary of Sweden’s Getinge , and Minneapolis-based Medtronic to meet additional pandemic-driven demand. The number of patients treated concurrently with ECMO in Australia and New Zealand peaked eight weeks after the first patient was treated and then decreased during the next four weeks, the authors said. At the peak, 23 patients across both countries were on ECMO on three consecutive days in early August. ECMO allows the lungs to recover while a machine takes over gas exchange. The units cost as much as 60,000 euros ($89,000) each, Josef Bogenschuetz, Maquet’s chief executive officer, said in an interview in July. In Australia and New Zealand, patients on ECMO received the treatment for an average of 10 days. Expensive Procedure A study last month in the Lancet , a U.K. medical journal, found average health-care costs were more than twice as high per patient for those selected for ECMO than for patients sent for mechanical ventilation. The average cost for those on ventilators was 33,435 pounds ($53,000) while the average ECMO treatment cost was 73,979 pounds. While doctors have favored so-called positive end-pressure ventilators for helping patients overcome severe breathing difficulties since the polio epidemic in the 1950s, ECMO emerged as a treatment option in the 1980s. About 2,000 adult respiratory patients had been given ECMO, researchers from the Washington University School of Medicine said in a 2008 study. “It’s been a therapy used for heart and lung transplant patients or patients with fairly severe heart failure,” Davies said. Improvements in the technology over the past decade have lowered the risk of hemorrhage and blood clots, making it a more viable option for lung-failure patients, he said. Even still, bleeding complications occurred in 54 percent of the flu patients on lung bypass, mostly at the point where ECMO tubes are inserted into veins in the groin or neck, the authors said. To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net .

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California Bond Sale Boosts Issuers’ Costs With Investors `Overstretched’

October 13, 2009

By Jeremy R. Cooke and Michael McDonald Oct. 13 (Bloomberg) — Borrowing costs for U.S. state and local governments are rising from a 42-year low after investors turned “cold and inhospitable” to the yields that municipal issuers led by California sought for their debt. Washington state will offer the week’s largest tax-exempt bond sale in a market where Morgan Stanley Smith Barney said dealers are becoming less willing to take on inventory that may undermine a profitable year. Issuers plan to sell about $8 billion of fixed-rate bonds, down from the eight-week high of $11 billion last week , based on data compiled by Bloomberg. Rebounding yields may reduce the savings states including Alabama, Mississippi and Maryland get from refinancing taxpayer- supported debt, as investors balk at low payouts while anticipating a Federal Reserve rate increase. The Bond Buyer 20 index of 20-year general obligation securities climbed to a three-week high of 4.06 percent after reaching its lowest since 1967 on Oct. 1. “It’s pretty obvious, interest rates are not going to stay at zero in any kind of economic recovery,” said Joseph Deane , who oversees the $4.9 billion Legg Mason Western Asset Managed Municipals Fund at Western Asset Management in New York. The fund’s five-year average return of 5.7 percent is best among its peers, according to Bloomberg data. “The first time the Fed finally tightens, I think that’s the best news you’re going to get in a long time,” he said in a telephone interview. “They’re telling you the economic crisis is abating.” Fed Fund Futures Trading in federal funds rate futures yesterday implied a 60 percent chance the U.S. central bank will raise its target for overnight lending between banks by April 2010. The target has been for a range of 0 to 0.25 percent since December, easing the way for credit markets to rally. The Municipal Master Index from Bank of America Corp.’s Merrill Lynch & Co. is up 14.9 percent for 2009, still better than any other year-to-date period since the total-return gauge began in 1989. The index fell 1.2 percent last week. The municipal market “got overstretched,” Deane said. “Everybody was just grabbing every bond they could get.” The gains were driven by investors pouring a record $65.5 billion into municipal bond mutual funds, according to data cited in an Oct. 9 report by George Friedlander , municipal strategist at Morgan Stanley Smith Barney in New York, a joint venture of Citigroup Inc. and Morgan Stanley. The previous full- year record was $42.9 billion in 1993. Tax-Exempt Supply Build America Bonds, introduced under the economic stimulus plan Congress approved in February, cut into the supply of new tax-exempt debt issues by enticing municipal issuers to borrow using taxable debt to receive a 35 percent federal interest rebate. Sales under the program since April exceeded $40 billion last week, a Bloomberg tally shows. Banks’ municipal departments, which reaped profits from the “massive rally in munis” this year, are becoming less willing to buy bonds from investors and hold unsold debt from new issues, according to Friedlander. “The mantra now seems to be ‘don’t mess it up,’ so some dealers and traders appear to be paring back their bid side significantly,” he said. Bondholders sought offers for almost $2 billion in securities Oct. 7, the highest since late June, according to a bids-wanted index compiled from Bloomberg data. California, the lowest-rated and most-populous U.S. state, reduced its bond deal last week by 8 percent to $4.14 billion and raised tax-exempt yields more than a quarter-percentage point from initial discussions. Delaware, one of seven states with the highest credit ratings, decreased the size of its refinancing by 9 percent to $314 million. ‘Inhospitable Market’ “We were able to get a $4 billion-plus deal in a cold and inhospitable market,” said Tom Dresslar , a spokesman in the California state treasurer’s office. “We believe that is a significant accomplishment.” The extra yield investors get for buying municipal bonds rated BBB instead of AAA widened by about three basis points last week to 228 basis points, after tightening from 446 basis points at the end of 2008, according to Merrill index data. A basis point is 0.01 percentage point. The falling yield premiums led Deane to reduce investments in riskier bonds “the past month, month and a half,” he said. “We’ve been diminishing our risk profile somewhat because we felt that this has been a terrific run, we’ve hit it on the screws and we’re willing to take a few chips off the table,” Deane said. Friedlander in his weekly report recommended against reaching for yield on general obligation bonds by “going down too much in credit quality.” Tight Budgets “Budgetary pressures at the state and local level are likely to continue for at least two years, and this should lead to more downgrades, even if defaults are limited as we expect,” he said. “Consider revenue bonds.” The largest municipal bond insurers by new issues this year sustained credit-rating cuts yesterday. Fitch Ratings reduced its financial strength grade on Assured Guaranty Corp. to the fourth-highest grade of AA- from AA. Assured’s Financial Security Assurance Inc. unit was downgraded to AA from AA+. Municipal issuers have scheduled at least $13.4 billion in fixed-rate bond sales during the next 30 days, 14 percent more than this year’s $11.8 billion average, according to a visible- supply index compiled from Bloomberg data. Following are descriptions of some pending sales of municipal bonds; the timing and amounts may change. WASHINGTON STATE plans to sell $1.38 billion of general obligation securities this week. Investment banks will bid to underwrite $875.2 million of tax-exempt debt tomorrow, and Goldman Sachs Group Inc. and JPMorgan Chase & Co. will market $500 million in taxable Build America Bonds Oct. 15, according to data compiled by Bloomberg. The deal will fund capital improvements and refinance debt. Washington is rated AA+ by Standard & Poor’s, Aa1 by Moody’s Investors Service and AA by Fitch Ratings. (Updated Oct. 13) NEW YORK CITY’S TRANSITIONAL FINANCE AUTHORITY, which helps raise capital-project funding for the most populous U.S. city, will issue $800 million of bonds backed primarily by personal income-tax revenue this week. The city agency also intends to convert $81 million of variable-rate demand notes to fixed-rate bonds. Underwriters led by Goldman Sachs will market the debt to individual investors today and tomorrow and to institutions such as mutual funds Oct. 15. About $684 million of the deal will be taxable Build America Bonds due in 10, 15, 25 and 30 years. The so-called future tax secured subordinate bonds are rated AAA by S&P, AA+ by Fitch and Aa2 by Moody’s. (Added Oct. 13) ALABAMA PUBLIC SCHOOL AND COLLEGE AUTHORITY may offer $775.8 million of tax-exempt revenue bonds as soon as this week through Morgan Stanley. All except $38.1 million will be used to refinance previous capital-improvement issues. The rest will finance new construction loans to local school boards. The bonds, rated Aa2 by Moody’s, are to be repaid from utility and sales taxes. (Updated Oct. 13) MISSISSIPPI plans to sell $622.9 million of general obligation bonds this week for economic development projects, public works and debt refinancing. Regions Financial Corp.’s Morgan Keegan & Co. and Morgan Stanley will handle the offerings. All except $64 million will be taxable; $98.3 million will be federally subsidized, Build America Bonds. Facilities for Toyota Motor Corp. and the B.B. King Museum in Indianola, Mississippi, are among the beneficiaries of the financing. The state’s full faith and credit pledge is rated AA by S&P and Aa3 by Moody’s. (Updated Oct. 13) UNIVERSITY OF MASSACHUSETTS will issue $525 million of bonds through its Building Authority as soon as this week. The offering, which will be underwritten by investment banks led by Citigroup, includes $167.5 million of Build America Bonds and $28.8 million of other taxable debt, according to preliminary offering documents. The majority will pay interest exempt from income taxes. The securities, rated Aa3 by Moody’s and A+ by S&P, will finance construction projects at the five-campus public university system, founded in Amherst. (Added Oct. 13) ATLANTA plans to offer $433.4 million of fixed-rate bonds backed by revenue from the city’s water and sewer system this week to replace variable-rate debt whose credit support is expiring Nov. 1. A group of investment banks led by Goldman Sachs Group Inc. will handle the refinancing, with maturities from 2010 through 2039. The bonds will be insured by Financial Security Assurance, rated AAA by S&P and Aa3 by Moody’s. Fitch rates the underlying water revenue backing BBB+; Moody’s assigns its Baa1. (Updated Oct. 13) HOUSTON INDEPENDENT SCHOOL DISTRICT plans to sell $250.8 million of tax-exempt securities set to be repaid by 2029 and $125.3 million of taxable Build America Bonds due in 2034. The debt, which will finance school construction for the largest public school system in Texas, is backed by property taxes. The federal government will also cover 35 percent of the interest on the taxable portion. A group of underwriting firms led by Royal Bank of Canada’s RBC Capital Markets will handle the financing as soon as this week. Houston ISD is rated Aa2 by Moody’s and AA+ by S&P. (Added Oct. 13) NEW YORK’S MOUNT SINAI SCHOOL OF MEDICINE will borrow almost $370 million by selling tax-exempt revenue bonds through the state’s Dormitory Authority this week. JPMorgan Chase & Co. leads underwriters on the deal, the proceeds of which will fund construction of the Center for Science and Medicine at the school in the East Harlem neighborhood of Manhattan. The bonds are rated A- by S&P. (Added Oct. 13) FAIRFAX COUNTY, VIRGINIA, will take interest-cost bids tomorrow from investment banks seeking to underwrite $265.1 million of general obligation bonds, $133.3 million of which may be designated federally subsidized, taxable Build America Bonds. The most populous jurisdiction in the Washington, D.C., metropolitan area, with more than 1 million people, will use the money to finance public improvements. Fairfax County is rated AAA by Fitch and S&P, and Aaa by Moody’s. (Updated Oct. 13) MASSACHUSETTS BAY TRANSPORTATION AUTHORITY, which operates the Boston area’s bus, subway and train system, plans to raise $253.2 million by selling debt, including $213.8 million of taxable Build America Bonds. Goldman Sachs will handle the deal. The securities, backed by sales taxes and rated AAA by S&P and Aa2 by Moody’s, will have a final maturity in 2039. The sale, which will pay for locomotives, subway cars and other capital investments, is scheduled for next week, said Jonathan Davis , the authority’s chief financial officer. (Updated Oct. 13) MARYLAND will offer almost $800 million of its top-rated general obligation bonds through competitive bidding among investment banks Oct. 21. Underwriters may choose to bid $58.2 million of the debt due from 2022 through 2024 as taxable Build America Bonds or tax-exempt debt. Almost $600 million of the deal will refinance higher-interest borrowings; the rest will finance facilities projects. (Added Oct. 13) CALIFORNIA PUBLIC WORKS BOARD plans to offer about $800 million of bonds backed by lease payments appropriated by the state. Underwriters led by Morgan Stanley and RBC Capital Markets will market the debt next week. About $600 million of the deal may be taxable Build America Bonds, with the rest tax- exempt. The proceeds will fund work on various state capital projects including a prison in Monterey County near Soledad. Fitch grades the bonds BBB-, one level above high-risk, high- yield junk status. Moody’s rates them one level higher at Baa2. S&P assigns its A- rating, the fourth-lowest investment grade. (Added Oct. 13) HAWAII wants to sell almost $700 million of general obligation bonds this month, mostly to refinance debt. Part of the deal will be $32 million of taxable Qualified School Construction Bonds from the federal stimulus, which provides a low- or no-interest loan to the state and compensates investors with U.S. tax credits. Merrill Lynch was selected to lead underwriters on the transaction. Hawaii, which operates the only statewide public school system in the U.S., had the highest net tax-supported debt as a percentage of personal income among states last year, according to Moody’s. The state is rated AA by Fitch and S&P and a comparable Aa2 by Moody’s. (Added Oct. 13) To contact the reporters on this story: Jeremy R. Cooke in New York at jcooke8@bloomberg.net ; Michael McDonald in Boston at mmcdonald10@bloomberg.net .

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Swine Flu Causes Lung Failure in Healthy Young People, Three Studies Find

October 12, 2009

By Tom Randall Oct. 12 (Bloomberg) — Swine flu caused otherwise healthy younger people to develop severe respiratory failure, a pattern of attack not seen since the 1918 flu that killed millions of people, according to three studies published today. Severe illness from swine flu, also know as H1N1, developed rapidly in patients admitted to the hospital, especially young people, and sent previously healthy people to intensive care units, according to studies of outbreaks in Canada and Mexico published today in the Journal of the American Medical Association. A third study from Australia and New Zealand found some patients benefited from a machine that replenished blood oxygen levels in extremely ill patients. Today’s reports are consistent with previous research that found that while H1N1 produces similar symptoms and outcomes as seasonal flu in most cases, it targets a younger population and can lead to severe illness and death. The seasonal flu kills about 36,000 people a year in the U.S., though the majority of those deaths are in people over the age of 80. “These studies provide important signals about what clinicians and hospitals may confront in the coming months,” said Douglas White and Derek Angus, professors of critical care medicine at University of Pittsburgh School of Medicine, in Pittsburgh, in an editorial accompanying the studies. “H1N1 can produce rapidly progressive respiratory failure.” In Canada, the average age of 168 patients studied was 32 years. Mechanical ventilation was required for 136 patients, and about 17 percent of the intensive care patients died. About 4,500 people have died worldwide from swine flu, which is widespread in most U.S. states. “The influenza outbreak lasted about three months” in Mexico and Canada, White and Angus wrote in the editorial. “The peak lasted just a few weeks, during which time hospitals struggled to accommodate the increased patient load.” To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

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Swine Flu Fueled 15-Fold Rise in Intensive Care Lung Cases in Australia

October 8, 2009

By Tom Randall Oct. 8 (Bloomberg) — Swine flu was found responsible for a 15-fold increase in intensive care unit admissions for lung inflammation in Australia and New Zealand, in the first detailed study of how the virus strikes in winter. During the peak of severe illness, swine flu patients filled 8.9 percent to 19 percent of all intensive-care hospital beds in each state of Australia and Zealand, according to the study published today in the New England Journal of Medicine . Almost 65 percent of intensive-care patients required mechanical ventilation. The Southern Hemisphere’s winter flu season, studied from June 1 to Aug. 31, may give health officials in the U.S. and Europe an early indication of what to expect in coming months, the researchers said today. The pandemic filled all available beds in some units and prompted doctors to postpone nonessential surgery, New Zealand’s health ministry said in July. “Our data indicate that the greatest effect on ICU resources in a given region occurs approximately 5 to 6 weeks after the first confirmed winter admission,” wrote the researchers from the Australian and New Zealand Intensive Care Society. “The 2009 H1N1 virus had a substantial effect.” H1N1 rates have subsided in the Southern Hemisphere, and the virus is now spreading widely in most U.S. states, according to the U.S. Centers for Disease Control and Prevention. The official winter flu season started in the U.S. on Oct. 4, and U.S. doctors began administering vaccines this week in the country’s largest flu vaccination program. Patients most at risk for severe complications in the study included infants under 1 year old, adults ages 26 to 64, pregnant women, the obese, and indigenous populations, according to the researchers. More than 16 percent of patients admitted to hospitals died, and a third of severely ill people had no underlying condition that would elevate their risk, according to the study. To contact the reporters on this story: Tom Randall in New York at trandall6@bloomberg.net

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Ramakrishnan, Steitz, Yonath Win Nobel Chemistry Prize for DNA Translation

October 7, 2009

By Andrea Gerlin Oct. 7 (Bloomberg) — Two Americans and an Israeli won the Nobel Prize in Chemistry for their work on how the DNA code is translated into life, findings that have been used to fight infectious disease. Venkatraman Ramakrishnan , 57, who heads the Structural Studies Division at the MRC Laboratory of Molecular Biology in Cambridge, England; Thomas A. Steitz , 69, Sterling Professor of Molecular Biophysics and Biochemistry at Yale University in Connecticut, and Ada E. Yonath , a professor at the Weizmann Institute of Science in Rehovot, Israel, will share the 10 million-krona ($1.4 million) award, the Nobel Assembly said at a press conference in Stockholm today. Their work revealed what ribosomes, which produce proteins that control the chemistry in all living organisms, look like and how they function at the atomic level. The Laureates also created three-dimensional models that show how different antibiotics bind to the ribosome, research that has been used to develop new anti-infective medicines. Yonath is the first woman to win the chemistry accolade in 45 years. “An understanding of the ribosome’s innermost workings is important for a scientific understanding of life,” the Nobel committee said in a statement . “These models are now used by scientists to develop new antibiotics, directly assisting the saving of lives and decreasing humanity’s suffering.” Ramakrishnan, reached at his office five minutes after being told of his achievement, said he was happy and surprised to be chosen. The three winners know each other well though they work separately, he said. ‘Fundamental Biology’ “It must have been a difficult decision; it’s been the subject of study by many groups over 40 years,” he said in a phone interview. “It’s fundamental biology.” Ramakrishnan, a U.S. citizen, was born in India in 1952. His parents were also scientists. He holds a doctorate in physics from Ohio University and is a senior scientist at the MRC Laboratory of Molecular Biology, in Cambridge, England. Steitz, also an American, was born in 1940 in Milwaukee, Wisconsin. He has a doctorate in molecular biology and biochemistry from Harvard University and teaches molecular biophysics and biochemistry at Yale. His son Jon Steitz is a former pitcher for the Milwaukee Brewers baseball team. Yonath was born in 1939 in Jerusalem and holds a doctorate in X-ray crystallography from the Weizmann Institute of Science, where she now teaches and conducts research. “The research behind these prizes shows how the transforming power of chemistry can improve peoples’ lives,” said Thomas H. Lane, president of the American Chemical Society, in an e-mailed statement. Few Women Of the 153 previous winners of the chemistry prize, only three were women. Marie Curie was chosen in 1911; her daughter, Irene Joliot-Curie , shared the prize with her husband, Frederic Joliot, in 1935; and Dorothy Crowfoot Hodgkin won in 1964. Last year’s prize in chemistry went to Osamu Shimomura of Japan and Martin Chalfie and Roger Y. Tsien of the U.S. for research that has turned green fluorescent protein, a luminous substance first found in jellyfish, into one of the most important tools in bioscience. Their research enabled scientists to track proteins that regulate everything from hunger to sexual drive. Annual prizes for achievements in physics, chemistry, medicine, peace and literature were established in the will of Alfred Nobel , the Swedish inventor of dynamite, who died in 1896. The Nobel Foundation was established in 1900 and the prizes were first handed out the following year. The first Nobel Prize in Chemistry was awarded to Jacobus H. van’t Hoff for his work on rates of reaction, chemical equilibrium and osmotic pressure. Yesterday, Charles K. Kao of the Chinese University in Hong Kong, 75, and Willard S. Boyle , 85, and George E. Smith, 79, of Bell Laboratories in Murray Hill, New Jersey, won the Nobel Prize in Physics for their work on fiber optics and digital imaging. On Oct. 5, Elizabeth Blackburn , 60, a professor at the University of California in San Francisco; Carol Greider , 48, a professor at Johns Hopkins University School of Medicine in Baltimore; and Jack Szostak , 56, a professor at Harvard Medical School in Boston, won the Nobel Prize in medicine for research on cell division and the “immortality enzyme” that can help them multiply without damage. To contact the reporter responsible for this story: Andrea Gerlin at agerlin@bloomberg.net

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Christmas Discovery on Cancer, Aging Brings Nobel to Two Women Scientists

October 6, 2009

By John Lauerman, Michelle Fay Cortez and Rob Waters Oct. 6 (Bloomberg) — It was Christmas Day, 1984, and Carol Greider , a 23-year-old first-year graduate student at the University of California, Berkeley, couldn’t stay away from the lab where she and assistant professor Elizabeth Blackburn were trying to untangle a genetic mystery. Greider had been testing an enzyme, one of the proteins that start chemical reactions in the body, and was impatient to check results. What she saw was “the first clear evidence” of how cells make telomeres, small parts of human DNA that allow genes to be replicated without the loss of protein-making information, Greider said in an interview yesterday. Her comments came just hours after she and Blackburn became the first two women to share a Nobel Prize for medicine. The enzyme, which Greider and Blackburn named “telomerase” is key to controlling unbridled cellular growth, the hallmark of cancer, as well as to age-linked disease, subsequent research has found. Blackburn, already an established scientist at age 35, often debated with her student how best to proceed. In the end, they created scientific history. “A brave student was needed to make this project drive along, and Carol was very willing to do that,” Blackburn said yesterday in an interview. “It was a great, fun kind of adventure because we didn’t know the answer. There was no chart telling us what to do.” Greider, now 48, is a molecular biologist with her own lab at Johns Hopkins University in Baltimore. Blackburn, 60, is at the University of California, San Francisco . The two women shared the Nobel Prize for Physiology or Medicine with Jack Szostak , 56, of Harvard Medical School in Boston, who began collaborating with Blackburn on the telomere research in 1980. Sharing the Prize The three scientists will share the 10 million Swedish kronor ($1.4 million) prize equally, the Nobel Assembly in Stockholm said. Blackburn said the honor for her and Greider is “a hopeful sign” for women. In the future, people will say, “Oh yes, it’s not too unusual to have women getting Nobel prizes,” Blackburn said in an interview. “Two got one this year. I hope it becomes very normal.” Research over the past decade suggests that telomeres are just one component in the complicated process of aging, said Leonard Guarente , a researcher at Massachusetts Institute of Technology, in Cambridge, Massachusetts. On the other hand, cancer cells, which divide and grow indefinitely, may be highly dependent on telomerase, he said. Combating Cancer “The biology of telomerase is critical to the cancer cell,” said Guarente, a scientific adviser to London-based GlaxoSmithKline Plc’s Sirtris Pharmaceuticals unit, the developer of anti-aging drugs, in a telephone interview. “Understanding this and developing ways to intervene may be one of the viable ways to combat cancer.” Diseases that have been linked to defects in telomerase activity include inherited forms of aplastic anemia, when the bone marrow doesn’t produce enough blood cells, and genetic forms of skin and lung ailments. The most intense research has been in cancer, where malignant cells have the ability to divide indefinitely, and in aging, which has been linked to short telomeres. Merck & Co ., a drugmaker based in Whitehouse Station, New Jersey, and Menlo Park, California-based biotechnology company Geron Corp . began testing a cancer vaccine last year that targets telomerase in patients with solid tumors, including lung and prostate cancer. Geron is testing another telomerase inhibitor in breast and plasma cell cancer. Repeating Pattern Blackburn, born on the island of Tasmania in Australia, became curious about telomeres in 1970s. She found they had a repeating pattern of six DNA building blocks, called bases, and wanted to find out how they were made. “The DNA was acting in ways that were completely unprecedented according to the textbooks, and so we knew something new was going on,” she said yesterday in an interview in San Francisco. The collaboration between her and Harvard’s Szostak began when Blackburn was studying a single-celled organism, called Tetrahymena , with an unusually large nucleus that made it easy to observe the DNA. Blackburn was studying the telomeres at the end of their chromosomes, trying to understand their structure. Szostak heard Blackburn present her findings at a medical meeting in 1980, and the two decided to combine their efforts. Blackburn isolated the DNA sequence from the single-cell pond organism, which Szostak linked to genetic strands called mini- chromosomes he had been working with. DNA Cap Blackburn’s DNA cap, now called a telomere, protected the mini-chromosome from damage, the researchers found. That was when Greider entered the picture, looking for the unknown enzyme that could be responsible for making telomeres. A native of Davis, California, Greider had overcome dyslexia to study biochemistry, according to her biography in the Proceedings of the National Academy of Sciences . The student worked 12-hour days and learned DNA cloning techniques to find the enzyme. She and Blackburn frequently debated research problems. They would eventually learn that the enzyme seen by Greider that Christmas day allows the entire chromosome to be copied before cell division begins. “This really is a tribute to curiosity-driven basic science,” Greider said yesterday in a press conference at John Hopkins. “We didn’t know at the time that there were any particular disease implications, we were just interested in the fundamental biology.” Stopwatch on Lifespan Some scientists hypothesized that telomeres, in effect, put a stopwatch on the lifespan of an organism by limiting the number of times that its cells can replicate before DNA damage ensues. Michael West founded Menlo Park-based Geron in 1990 with the goal of extending extend human life expectancy into the hundreds of years. “I used to say at Geron that between 5 and 95 percent of human aging is in the telomere,” said West, now president and chief executive officer of BioTime Inc ., in Alameda, California. “Now I’d say it’s probably about 80 percent.” MIT’s Guarente credited Blackburn for making the study of telomeres one of the scientific fields that is most friendly to women. About half of the researchers in the field are women, said Titia de Lange, a professor of cell biology and genetics at Rockefeller University in New York, who studies aging. “It would be great if, in the future, women got 50 percent of all the awards,” she said in a telephone interview. “What’s needed is gender equality in the upper echelons of science.” 800 Nobelists More than 800 people have been awarded Nobel Prizes from 1901 through 2008, and 36 of them have been women, according to the Nobel Web site . The relative lack of prizes for women discourages young female researchers, said Phoebe Leboy, president of the Association for Women in Science , in Washington. “It’s one of the major issues faced by women in science,” she said in a telephone interview. “When a really bright graduate student wants to work with someone, they’re looking for someone with power and prestige.” With fewer prizes, women are less likely to get the top students, who are more likely to write ground-breaking papers, working for them, Leboy said. She has a grant for $800,000 to study why women are often shut out of science prizes and how to correct it. “When scientists are sitting around a table thinking about who deserves an award, a lot of the guys don’t think of women,” she said. “Men have been habituated not to think about women when they think of prizes.” Persistent Bias While women’s status in the laboratory has improved over the past few years, there are still many signs of persistent bias, said Gioia De Cari, who got a master’s degree in mathematics at MIT in the late 1980s. She had dropped writing a one-woman play about her experiences in male-dominated academia until she heard that former Harvard University President Lawrence H. Summers said in January 2005 that innate differences might explain women’s lack of success in math and science. “I thought, ‘Maybe this isn’t so passé,’” she said in telephone interview. “He was an unlikely muse for a woman playwright.” De Cari’s play, “ Truth Values: One Woman’s Romp Through MIT’s Male Math Maze ,” will be performed at the City University of New York Graduate Center for one night, Oct. 9, in Manhattan. To contact the reporters on this story: John Lauerman in Boston at jlauerman@bloomberg.net ; Rob Waters in San Francisco at rwaters5@bloomberg.net ; Michelle Fay Cortez in London at mcortez@bloomberg.net .

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Fiber Optics, Digital Imaging Pioneers Kao, Boyle, Smith Win Physics Nobel

October 6, 2009

By Trista Kelley Oct. 6 (Bloomberg) — Three scientists whose research helped speed up the transmission of information won the Nobel Prize in Physics. Charles K. Kao , who worked at Standard Telecommunications Laboratories in Harlow, U.K., and now teaches at the Chinese University in Hong Kong; Willard S. Boyle and George E. Smith of Bell Laboratories in Murray Hill, New Jersey, will share the 10 million-kronor ($1.4 million) prize, the Nobel Assembly said today in Stockholm. The research “helped to shape the foundation of today’s networked societies,” according to a statement. “They have created many practical innovations for everyday life and provided new tools for scientific exploration.” Kao’s research led to a breakthrough in fiber optics while Boyle and Smith invented the first successful imaging technology using a digital sensor. Last year’s physics prize went to Yoichiro Nambu of the U.S., and Makoto Kobayashi and Toshihide Maskawa of Japan for showing how subatomic particles that are supposed to act similarly sometimes don’t, leading to a better explanation of how the universe was formed. Annual prizes for achievements in physics, chemistry, medicine, peace and literature were established in the will of Alfred Nobel , the Swedish inventor of dynamite, who died in 1896. The Nobel Foundation was established in 1900 and the prizes were first handed out the following year. In 1901 the first Nobel Prize in Physics was awarded to Wilhelm Röntgen for his discovery of X-rays. The physics prize has since been awarded for discoveries and inventions, according to the Nobel Prize Web site. Yesterday, Elizabeth Blackburn , 60, a professor at the University of California in San Francisco; Carol Greider , 48, a professor at Johns Hopkins University School of Medicine in Baltimore; and Jack Szostak, 56, a professor at Harvard Medical School in Boston, won the Nobel Prize in medicine for research on cell division and the “immortality enzyme” that can help them multiply without damage. To contact the reporter on this story: Trista Kelley in London at tkelley2@bloomberg.net

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Burlington Northern Santa Fe Corporation Elects Dr. Cynthia Ann Telles to Its Board

September 28, 2009

FORT WORTH, TX–(Marketwire – September 28, 2009) – The Board of Directors of Burlington Northern Santa Fe Corporation ( NYSE : BNI ) today announced the election of Dr. Cynthia Ann Telles to its Board. Dr. Telles is a professor in the UCLA School of Medicine and the Director of the Spanish Speaking Psychosocial Clinic of the UCLA Neuropsychiatric Institute and Hospital. The appointment is effective September 24, 2009. In making the announcement, Matthew K. Rose, BNSF chairman, president and chief executive officer, said, “We are delighted to welcome Dr. Telles to our Board. She adds a unique, new perspective to our Board with her distinguished 30-year career in medicine at UCLA as well as more than 25 years of experience in public service.”

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Roche’s Eureka Moment on Brain Disorder May Spur Probe of Autism Mystery

September 19, 2009

By Dermot Doherty Sept. 18 (Bloomberg) — Researcher Luca Santarelli wasn’t sure what do to with an experimental medicine developed in the labs of his employer, Roche Holding AG , until a 2007 meeting with a concerned father led to a “Eureka moment.” Mike Tranfaglia, whose son has the rare brain disorder Fragile X syndrome , met Santarelli to present new research linking the disease to a chemical in the brain that may also play a role in Alzheimer’s and autism . Santarelli, 41, says this made him see how the experimental drug could be used to treat Fragile X, the most common inherited form of retardation. Roche may test the pill in patients this year. “In one hour the whole relevant literature is presented to you and you come away with a gut feeling that this could work out,” Santarelli, Roche’s head of central nervous system exploratory development, said in an interview. “For a scientist, a Eureka moment is why we live and do this job. You have very few, but that was one of them.” Armed with newly uncovered links between biology and brain disorders, Roche and Novartis AG are racing smaller drugmakers to develop the first medicine to treat Fragile X, a genetic disease thought to affect about 250,000 people. While analysts estimate such a pill may generate as little as $250 million in annual sales, studying the treatment may reveal ways to treat other illnesses of the central nervous system, estimated by London-based Datamonitor Plc to have been worth $96 billion in 2007 in seven major markets. Proof of Concept “For us, Fragile X is like a proof of concept,” Santarelli said. “If we can crack this, then we can move into a broader range of neuro-developmental disorders.” Developing a treatment for the disease may prove to be a challenge. While the early results look promising, most experimental medicines fail to make it through the three phases of clinical testing needed for marketing approval. The link between the diseases comes from studying glutamate, the most common neurotransmitter, or chemical that allows for communication between neurons in the brain. Perturbations in glutamate signaling are now thought to contribute not only to Fragile X, but also to conditions such as Alzheimer’s, depression, autism and even heartburn. Since many people with forms of autism that are genetically unrelated to Fragile X seem to have defects in the same cellular pathways, they may respond to the same treatments, according to the Newburyport, Massachusetts-based Fragile X Research Foundation . Tranfaglia, a psychiatrist, founded the organization, known as FRAXA, in 1994 after his son Andrew, now 20, was diagnosed. No Cure There’s no cure for Fragile X, which can cause a broad range of symptoms, from fidgeting to impulsive actions, according to the U.S. National Institutes of Health . About 33 percent of males with the disorder have autism or autistic-like behavior, the NIH says. Fragile X is also the most common cause of autism that has been identified so far, according to the National Fragile X Foundation. Scientists may be on the cusp of developing treatments for Fragile X because of two breakthroughs in neuroscience. One was the discovery in 1991 by a team headed by scientist Stephen Warren at Emory University in Atlanta that the syndrome is linked to the mutation of a specific gene located on the X chromosome. The disease got its name from the abnormal appearance of the end of the X chromosome’s long arm. Faulty Gene The fault in the gene inhibits the production of a protein called FMRP, which is responsible for keeping levels of other neuronal proteins in check. The excess of some proteins that results from the FMRP deficit impairs brain development and causes Fragile X. The other breakthrough was work done by neuroscientists led by Mark Bear, then at Brown University in Providence, Rhode Island, who in 2000 showed that blocking the production of glutamate can help counterbalance the effects of reduced FMRP levels. This was the finding that Tranfaglia gave Santarelli. “Only a few years back people would have thought it was impossible to treat diseases like schizophrenia and autism with drugs that are not just targeting symptoms but that address the molecular basis of the disease,” Santarelli said. “But we think we can do that now.” Roche’s experimental medicine inhibits glutamate production and prevents the excessive output of other proteins by binding to a specific receptor called mGluR5. Brake and Throttle “FMRP is the brake and glutamate is the throttle” in the production of many proteins in nerve cells, Santarelli said. “If you take away the brake, you have only the throttle, so you want to take that away too.” By keeping the level of proteins in check, the treatment may prevent damage and reverse symptoms such as learning problems, anxiety and autistic behaviors caused by Fragile X. Basel, Switzerland-based Roche has said study results obtained so far with its compound have been “encouraging.” The drugmaker probably will test the experimental medicine in autism if the results of animal studies are positive, Santarelli said. Roche declined to give details about the trials. Drugs currently used in autistic patients are focused on treating symptoms such as anxiety and depression, aggression, seizures and hyperactivity. Medicines used include Pfizer Inc.’s antidepressant Zoloft, the generic antipsychotic medicine haloperidol and Novartis AG’s attention deficit disorder pill Ritalin. Behavioral therapy is the standard approach to treatment, according to the patient organization Autism Speaks . ‘Secret Hope’ This medicine “could be the first to reverse mental retardation,” Randi Hagerman , a professor at the University of California at Davis who’s working with Roche on the clinical trials, said in an interview. “What everyone is hoping is that the causes of autism may converge on a final common pathway that may be sensitive to this drug. The secret hope is that we might find it can be used much more broadly than for Fragile X.” The first Fragile X medicine that targets the mGluR5 receptor may reach the market by 2011 or 2012, said Hagerman, who has also worked with Cortex Pharmaceuticals Inc., Neuropharm Group Plc and Seaside Therapeutics . Children would likely get medication soon after diagnosis, typically at two or three years old, Tranfaglia said. “Most Fragile X kids are born as essentially normal babies,” Tranfaglia said. “There’s really nothing wrong with them at first, but they simply don’t develop at the normal rate. The hope is that down the line you would start the medication shortly after diagnosis, and this would prevent much of the abnormal development of the brain that leads to the symptoms.” Limited Market The market may be worth from $250 million to $1 billion a year, depending on pricing and what exactly the drug is approved for, said Robin Davison , an analyst at Edison Investment Research in London. Symptoms of Fragile X tend to be much more pronounced in men than in women because males only have one X chromosome. If one of a woman’s X chromosomes has a genetic mutation, the other, unaffected one can compensate for it and females may not need treatment. Neuropharm is testing a compound called fenobam, which also targets mGluR5. A study in the second of the three stages of testing generally required for approval found last year that four of six males and two of six females responded to the treatment. There were no significant side effects. Novartis is in the second of three stages of clinical testing with its compound, spokesman Jeff Lockwood said in an e- mailed statement. The company declined to give additional details about the trials. Trials Beginning Seaside, co-founded by Bear, expects to begin clinical trials with its mGluR5 compound this year and already has another kind of compound that targets glutamate in the second of three phases of testing. Swiss biotechnology company Addex Pharmaceuticals Ltd. is also working on compounds that target mGluR5, though it has no plans to test them in Fragile X. “Our two lead products could certainly be developed by Addex or a potential partner of Addex for Fragile X, but we’ve chosen to prioritize other indications like heartburn, migraine and Parkinson’s where the market potential is big and clinical testing is faster and cheaper,” spokesman Chris Maggos said in a telephone interview. Medicines being developed for Fragile X are likely to benefit from so-called orphan drug status, Hagerman said. Neuropharm’s fenobam has already been granted the designation, which is given to treatments aimed at serious diseases affecting fewer than 200,000 people in the U.S. or fewer than five of 10,000 people in Europe. It gives companies a seven-year period of market exclusivity in the U.S. The medicines also get a speedier review. Unmet Medical Need “Fragile X is certainly an unmet medical need,” Bear, now professor of neuroscience at the Massachusetts Institute of Technology in Cambridge, Massachusetts, said in an interview. “It’s a severe psychiatric disorder with a lot of features like epilepsy, obsessive compulsive behavior, autistic behavior, cognitive impairment. Everyone will be looking very closely to see which aspects of the disease are going to respond to these drugs.” To contact the reporter on this story: Dermot Doherty in Geneva at ddoherty9@bloomberg.net

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Glaxo Cancer Vaccine Recommended by FDA Panel; Merck Shot Backed for Boys

September 9, 2009

By Catherine Larkin Sept. 9 (Bloomberg) — GlaxoSmithKline Plc won a U.S. advisory panel’s backing to introduce Cervarix, the first cervical cancer vaccine to compete with Merck & Co. ’s Gardasil. The panel separately recommended expanding Gardasil use to boys. The shots were ruled safe and effective by a panel of outside advisers to the Food and Drug Administration meeting today in Gaithersburg, Maryland. Both protect against strains of human papillomavirus , or HPV, a common sexually transmitted virus that can cause serious infections. The FDA usually follows its panels’ recommendations, though it isn’t required to do so. While regulatory delays for Cervarix gave Merck a head start on the U.S. market in 2006, Glaxo aims to capitalize on slowing sales of Gardasil. The London-based drugmaker’s biggest challenge will be winning over doctors and parents to Cervarix, according to analysts. Gardasil is already recommended by U.S. health officials for school-age girls and comes with added protection against genital warts. “Cervarix is approved in many markets outside of the U.S. already” where it has “approximately 35 percent sales market share,” said Tim Anderson , an analyst at Sanford C. Bernstein & Co. in New York, in a note to clients last week. “In the U.S., the product will be roughly three years behind Gardasil’s introduction, and our belief is that it will not capture as much share in the U.S. as it has internationally.” American depositary receipts of Glaxo, each representing two ordinary shares, rose 20 cents to $39.22 at 4:04 p.m. in New York trading, before the meeting ended. Merck, of Whitehouse Station, New Jersey, gained 58 cents, or 1.9 percent, to $31.55. Merck shares have increased 39 percent since it announced plans on March 9 to buy Schering-Plough Corp. HPV Prevalence Twenty million Americans are infected with HPV, and most will be able to fight off the infection naturally. This year, an estimated 11,270 new cases of cervical cancer will be diagnosed in the U.S. and 4,070 women will die of the disease, according to the National Cancer Institute . About 1 percent of sexually active American men will develop genital warts from HPV, according to U.S. Centers for Disease Control and Prevention. Gardasil and Cervarix, given in three doses during a six- month period, trigger immune responses that help protect against the two HPV strains responsible for most U.S. cervical cancer cases. Gardasil also protects against two additional strains of HPV that cause 90 percent of genital warts. The shot costs about $400 and is approved for females ages 9 to 26. The FDA is scheduled to make a decision by the end of this month whether to approve Cervarix’s use in women ages 10 to 25. The shot is cleared in 98 countries and had sales of 125 million pounds ($232 million) last year, or about one-sixth as much as Gardasil. The average estimate of three analysts surveyed by Bloomberg calls for sales of 758 million pounds in 2012. Cervarix Delay Safety concerns, including a higher number of young women who reported miscarriages after getting Cervarix, contributed to the delay with Glaxo’s March 2007 application, according to an FDA staff review released before today’s meeting. The difference in miscarriages wasn’t statistically significant and most of the FDA advisers said Glaxo’s plan to register patients and monitor pregnancies would mitigate any potential risks. Cervarix should “just be marketed with the usual caveat that it shouldn’t be used during pregnancy,” said panel member Kenneth Noller, a professor in the obstetrics and gynecology department at Tufts University School of Medicine in Boston. “I don’t see anything compelling with these data at all.” Expanded use of Gardasil in boys would help Merck counter competition from Cervarix in the girls’ market. The shot is available in more than 100 countries, including at least 40 where it is cleared for males. The FDA should decide by the end of October whether to approve Gardasil’s use in boys and young men ages 9 to 26 to prevent genital warts. Side Effects of Gardasil U.S. officials have received 12,424 reports of side effects with Gardasil, about 54 reports for every 100,000 vaccine doses distributed, according to a recent study in the Journal of the American Medical Association. Only one person on the 13-member panel voted against the safety and effectiveness of either Cervarix or Gardasil, citing lack of long-term proof that HPV vaccines are safe. “There are too many issues going on,” said Vicky Debold, the panel’s consumer representative. “We need to figure this out before we subject boys to risks that are not necessary at this point. This is a very, very important issue in terms of public confidence.” Sales Decline Questions about side effects and cost caused Gardasil sales to drop 5 percent last year to $1.4 billion, or 5.9 percent of Merck’s revenue . Sanofi-Aventis SA , based in Paris, helps market the product in some European countries. Anderson, of Sanford Bernstein, estimates expanded use in boys will boost sales to $2.43 billion in 2015. Merck had sought approval to sell Gardasil to prevent pre- cancerous lesions in boys and young men, as well as genital warts. The FDA told the company in May the proposal for prevention of “external genital lesions” was too broad, according to the FDA’s staff review. This restriction may hurt Merck’s ability to prove the shot is cost effective for boys, said Keyur Parekh , a UBS AG analyst in New York, in a Sept. 4 note to clients. The CDC’s Advisory Committee on Immunization Practices, a 15-member panel that sets national recommendations for vaccine use, probably will review Cervarix and Gardasil for boys in late October, Parekh said. To contact the reporter on this story: Catherine Larkin in Gaithersburg, Maryland at clarkin4@bloomberg.net .

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J&J Wins Appeal Reviving Patent on Ultracet Drug as It Fights Teva Generic

August 26, 2009

By Susan Decker and William McQuillen Aug. 26 (Bloomberg) — Johnson & Johnson won an appeals court ruling that it can try to use its patent on the Ultracet painkiller to block generic-drug makers including Teva Pharmaceutical Industries Ltd. from selling copies of the drug. The U.S. Court of Appeals for the Federal Circuit in Washington overturned a finding that the patent was invalid and sent the case back to a lower court for trial. The court did affirm that one aspect of the patent was invalid. Teva’s Barr unit and Caraco Pharmaceutical Laboratories Ltd. have been selling copies of the medicine for more than three years. New Brunswick, New Jersey-based J&J, the world’s largest health-products company, was trying to get the generic medicines pulled from the market. Ultracet combines acetaminophen, the main ingredient in Johnson & Johnson’s Tylenol, with tramadol hydrochloride, a compound used in the painkiller Ultram. The patent, which expires in August 2011, covers the ratio between the two components. The Federal Circuit, in a 2-1 ruling, said there were “material questions of fact” as to whether the combination would have been obvious to researchers. Circuit Judge Haldane Robert Mayer disagreed, saying the patent “does nothing more than combine two well-known pain relievers” into a single tablet. Detroit-based Caraco is owned by Sun Pharmaceutical Industries Ltd. of Mumbai. Teva, based in Petah Tikva, Israel, is the world’s biggest generic-drug maker. The case is Ortho-McNeil Pharmaceutical Inc. v. Teva Pharmaceutical Industries Ltd., 2008-1549 and 2008-1550, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Ortho-McNeil Pharmaceutical Inc. v. Kali Laboratories Inc., 6cv3533, U.S. District Court for the District of New Jersey (Newark). To contact the reporters on this story: Susan Decker in Washington at sdecker1@bloomberg.net ; William McQuillen in Washington at bmcquillen@bloomberg.net .

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MedLink Appoints Dr. Abha Agrawal to Medical Advisory Board

August 20, 2009

RONKONKOMA, NY–(Marketwire – August 20, 2009) – MedLink International, Inc. ( OTCBB : MLKNA ) is pleased to announce the appointment of Abha Agrawal, MD, FACP to the company’s Medical Advisory Board. Dr. Agrawal is the Interim Medical Director of Kings County Hospital Center, Brooklyn, NY. Prior to this role, she was the Chief Medical Information Officer of the Central Brooklyn Family Health Network (CBFHN) and the Associate Medical Director of Kings County Hospital. She is also an Associate Professor of Medicine as well as Medical Informatics at SUNY Downstate Medical Center.

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Stocks, Commodities Fall as China Enters Bear Market; Yen, Treasuries Rise

August 19, 2009

By Daniel Hauck and Kayla Carrick Aug. 19 (Bloomberg) — Stocks fell around the world, briefly pushing China into a bear market, as concern economic and earnings growth will falter triggered declines in equities and commodities and boosted the yen and Treasuries. The MSCI World Index of 23 developed nations sank 0.6 percent at 9:42 a.m. in New York and the Standard & Poor’s 500 Index slid 0.6 percent. China’s Shanghai Composite Index slumped as much as 5.1 percent, extending its drop from a 2009 high to more than 20 percent, the common definition of a bear market. Copper fell 3.8 percent. The yen strengthened against all 16 of the most-traded currencies tracked by Bloomberg and the pound weakened. The 10-year Treasury yield dropped to a five-week low. “People are hanging their hopes on China pulling us out of a recession,” said Brad Brooks , senior money manager at Value Line Securities, which oversees $2.5 billion in New York. “China’s growth looks great, but things may be a bit overstated. There has been a lot more integration of global markets over the past couple of years. We’ve had a tremendous run and we’re due for this pullback.” The U.S. and Chinese governments pledged more than $13 trillion to combat the worst financial crisis since the Great Depression, helping to fuel a nine-month rally in the Shanghai Composite that pushed the index’s price-to-earnings ratio to almost double the valuations for the S&P 500, according to data compiled by Bloomberg. Earnings for Chinese companies that reported since July 8 have trailed analysts’ estimates by 12 percent on average, Bloomberg data show. Declining Loans The Shanghai Composite lost 4.3 percent today as Maanshan Iron & Steel Co. tumbled 7.5 percent. The company posted a half- year loss for the second consecutive period as the global recession curbed demand from homebuilders and automakers. The Shanghai gauge has still climbed 53 percent this year. China’s stocks slumped this month as new loans in July declined to less than a quarter of June’s level and companies including Yunnan Copper Industry Co. reported losses. The Shanghai composite’s retreat has left it trading at less than half the record level in October 2007 . China’s stock market has foreshadowed moves in global equities the past two years. It peaked on Oct. 16, 2007, two weeks before the MSCI All-Country World Index . The Shanghai index fell 72 percent from its 2007 high and bottomed on Nov. 4, 2008, four months before the MSCI index. The Chinese measure reached its 2009 high on Aug. 4, seven trading days before the global index. Focus on China “The focus of global markets is what’s happening in China,” said Bartosz Pawlowski , a London-based emerging-markets strategist at BNP Paribas SA. “China will have to remove liquidity from the market, and it’s likely that commodities will suffer and it means worse sentiment towards risk in general.” The Dow Jones Stoxx 600 Index of European shares retreated 0.8 percent today. A 42 percent rebound since March 9 has driven the regional measure’s valuation to 40.2 times the profits of its companies, near the most expensive level since 2003, weekly data compiled by Bloomberg show. Alcoa Inc. , the largest U.S. aluminum producer, slid 5.1 percent to $12.26. Aluminum, copper, lead and nickel dropped in London and Goldman Sachs Group Inc. downgraded the company’s shares to “neutral” from “buy.” Hewlett-Packard Co. slipped 2.6 percent to $42.83 after the company’s fourth-quarter revenue forecast indicated that lower computer prices are eating into sales. Revenue this quarter will grow about 8 percent from the previous three months, Hewlett-Packard said yesterday, suggesting sales of about $29.6 billion. Analysts in a Bloomberg survey predicted $29.8 billion on average. Deere Drops Deere & Co. , the world’s largest maker of agricultural equipment, lost 3.2 percent to $43.65 in New York. The company posted third-quarter profit of 99 cents per share, beating the 56-cent average estimate of analysts surveyed by Bloomberg, while giving a forecast that implied it will have a near break- even fourth quarter. Analysts projected profit of 35 cents a share for the period. The MSCI Emerging Markets Index dropped 1.1 percent. India’s Bombay Stock Exchange Sensitive Index lost 1.5 percent, while Indonesia’s Jakarta Composite index fell 2.5 percent. Hungary’s forint led declines in east European currencies against the euro as the tumble in Chinese shares prompted investors to sell emerging-market assets. Copper for delivery in three months fell 3.8 percent to $5,849.50 a metric ton on the London Metal Exchange. Crude oil retreated 1 percent to $68.50 a barrel in New York. China is the world’s second-largest oil user. ‘Monetary Medicine’ Investors are concerned that governments and their central banks will struggle to withdraw stimulus packages that have eased the global economic recession. “Enormous dosages of monetary medicine continue to be administered and, before long, we will need to deal with their side effects,” billionaire Warren Buffett said. Pacific Investment Management Co., which runs the world’s biggest bond fund, said the dollar will weaken as the U.S. pumps “massive” amounts of money into the economy. Treasuries advanced as investors sought the relative safety of U.S. bonds, driving the yield on the 10-year note 9 basis points lower to 3.42 percent. The two-year yield dropped 6 basis points to 0.97 percent. Bonds, Currencies The Federal Reserve is scheduled to buy Treasuries due from February 2020 to February 2026 today, part of its plan to cap consumer borrowing costs, according to its Web site. The yen strengthened most against the pound after minutes of the Bank of England’s Aug. 6 meeting showed Governor Mervyn King wanted a larger increase in the central bank’s asset- purchase program. The dollar rose versus all 16 major currencies tracked by Bloomberg except the yen and the Swiss franc. The cost of hedging against losses on U.K. government debt rose to the highest in a month after David Cameron , the leader of the opposition Conservative Party, said high borrowing levels put the country at risk of default. Credit-default swaps tied to Britain rose 2 basis points to 62, according to CMA DataVision prices. That compares with contracts on Germany at 26.5 basis points and Portugal at 63.5 basis points, CMA prices show. The U.K.’s debt burden is the highest since 1976, when it sought an emergency loan from the International Monetary Fund to keep up overseas payments. The Treasury said in April it will borrow 269 billion pounds ($440 billion) more than previously forecast as the recession cuts tax revenue. Economic Watch Confidence in the world economy surged to a 22-month high in August on signs the first global recession since World War II is approaching an end, a Bloomberg survey of users on six continents showed last week. The U.S. unemployment rate dropped in July for the first time since April 2008, data from the Labor Department showed this month. The Organization of Economic Cooperation and Development said today that the economies of its 30 members collectively stopped shrinking in the second quarter as Japan, France and Germany exited recession. The cost of protecting corporate bonds from default jumped to the highest in a month, according to JPMorgan Chase & Co. prices for credit-default swaps. Contracts on the Markit iTraxx Europe index rose 3.25 basis points to 103.25, and the risk gauge has now climbed 23 percent since Aug. 10. To contact the reporters on this story: Daniel Hauck in London at dhauck1@bloomberg.net ; Kayla Carrick in New York at kcarrick1@bloomberg.net

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Johann Hari: The Horrifying Hidden Story Behind Drug Company Profits

August 4, 2009

This is the story of one of the great unspoken scandals of our times. Today, the people across the world who most need life-saving medicine are being prevented from producing it.

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Agent Orange Spray Raises Risk of Parkinson’s, Heart Disease, Panel Says

July 24, 2009

By Rob Waters July 24 (Bloomberg) — Agent Orange, the herbicide sprayed by the U.S. Army on the jungles of Vietnam during the war from 1962 to 1971, may have triggered Parkinson’s and heart disease in American soldiers who fought there, a panel of experts said. The conclusion, from a committee of the Institute of Medicine in Washington, said there is now “suggestive evidence” of a link between the chemical and the two diseases.

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French Fries in New York Get Healthier in Trans-Fat Crackdown, Study Finds

July 20, 2009

By Elizabeth Lopatto July 20 (Bloomberg) — French fries at restaurants run by McDonald’s Corp., Wendy’s/Arby’s Group Inc . and privately held White Castle Restaurants have 98 percent less trans fat and 10 percent less saturated fat in New York since the city’s health commission banned artificial trans fats in restaurants, a study found

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Alzheimer’s Angst Builds for Elan, Wyeth, Pfizer as Rival Drugs Fail Tests

July 20, 2009

By Michelle Fay Cortez July 20 (Bloomberg) — The leading Alzheimer’s drug discovery strategy being pursued by companies including Wyeth and Elan Corp. appears increasingly risky as new studies emerge. More than a dozen drugs now in human testing were designed to slow progression of the illness by blocking the proteins that form clumps in the brain

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