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【转帖】Medivation Tumbles on Dimebon Trial Failure
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Medivation Tumbles on Dimebon Trial Failure Sign in to RecommendTwitter Sign In to E-Mail Print By THE ASSOCIATED PRESS Published: March 3, 2010 NEW YORK (AP) -- Shares of Medivation Inc. plunged Wednesday after the failure of Dimebon, an Alzheimer's drug the company is developing with Pfizer Inc. Medivation stock lost about two-thirds of its value and fell to an annual low Wednesday morning. Before the market opened, Medivation and Pfizer said data from a late-stage trial showed Dimebon was no better than a placebo at improving symptoms of Alzheimer's, including mental abilities and overall function. In midday trading, shares of the San Francisco biotechnology company sank $26.94, or 66.9 percent, to $13.31, making them the biggest decliner on the Nasdaq. Earlier the stock reached $12.55, its lowest point since December 2008. Pfizer shares shed 19 cents to $17.41. Medivation and New York-based Pfizer teamed up to codevelop Dimebon in late 2008, and some analysts saw the drug as a top earner for Pfizer in the future. Medivation stands to receive hundreds of millions in milestone payments along with royalties on sales if the drug is approved. Dimebon is being tested as a treatment for both mild to moderate and moderate to severe Alzheimer's disease, along with Huntington's disease. Rodman & Renshaw analyst Elemer Piros downgraded Medivation shares on the news, cutting his rating to ''Market Perform'' from ''Market Outperform.'' He said it looks like Dimebon will not work against Alzheimer's or Huntington's. ''The companies should stop any further development activity for the drug, in our view,'' he wrote. Piros said Medivation shares are worth about $16 based on the company's other potential drugs. Four other late-stage trials of Dimebon are currently under way. BMO Capital Markets analyst Robert Hazlett said the drug appeared effective in midstage studies, but he is now skeptical the drug will reach the market. He cut his 2016 revenue estimate for Pfizer by almost $1 billion. ''This initial Phase 3 failure casts large doubt on the drug's prospects,'' he wrote. Hopes for Alzheimer’s Drug Are Dashed By ANDREW POLLACK Published: March 3, 2010 It seemed somewhat unlikely, but in recent years an old Russian hay fever pill had become one of the world’s best hopes for treating the growing epidemic of Alzheimer’s disease. Add to Portfolio Pfizer Inc Medivation, Incorporated Go to your Portfolio » But those hopes were dashed on Wednesday when the drug failed in its first late-stage clinical trial, dealing a blow not only to patients with Alzheimer’s and their families but to the companies developing the treatment — a start-up in San Francisco called Medivation and the world’s largest drug company, Pfizer. The companies said in a statement that the drug, called Dimebon, had shown virtually no effect after six months in treating the cognitive decline or behavioral problems associated with Alzheimer’s when compared with a placebo. The result was somewhat surprising, because in a smaller previous trial, Dimebon had shown what some experts characterized as better results than any of the drugs already approved for Alzheimer’s disease. It seemed to improve cognitive function or at least stave off mental decline for about 18 months, while the existing treatments do so for only about six months, experts said. As recently as last week, an Alzheimer’s researcher had said of Dimebon, “The clinical data is by far and away superior to anything that’s ever been shown before.” That researcher, Mark A. Smith, of Case Western Reserve University, is a consultant to Medivation who is trying to figure out how the drug works. Still, some doctors and Wall Street investors had been a bit skeptical, because that earlier trial had been done in Russia, making it hard to determine how the study was conducted. Also, the mechanism by which Dimebon worked was never clear. “It just seemed too good to believe,” Dr. John Q. Trojanowski, director of the Alzheimer’s center at the University of Pennsylvania, said in an interview Wednesday. The skeptics were borne out by the results of the new trial, called Connection, which involved 598 patients with mild to moderate Alzheimer’s disease in Europe and in North and South America. “The outcome for the Connection trial was unexpected,” Dr. David Hung, the chief executive of Medivation, told securities analysts in a conference call Wednesday. “With this data we have to reconsider the entire program.” Shares of Medivation lost two-thirds of their value Wednesday, plummeting to $13.10. Before the results were announced, Medivation, which has no products on the market, had a market valuation of $1.3 billion based largely on the prospects for Dimebon. The big questions now are whether the companies abandon other trials already under way for Dimebon or whether Pfizer itself, which has been paying 60 percent of the development costs, pulls out. Executives at both companies said they needed to further analyze the results before making such decisions. Dimebon, also known as latrepirdine, was sold as an antihistamine in Russia starting around 1983, though production and sales of the drug had stopped some years ago. In the 1990s, Sergey Bachurin, a scientist at the Institute of Physiologically Active Compounds in Russia, had started screening chemicals that might be used to treat Alzheimer’s. He discovered that the already approved antihistamine seemed to fit the bill. The researchers tested the drug in animals and in a small group of patients, then filed for patents. Sergey Sablin, a former researcher at the Russian institute who moved to San Francisco, shopped around for American investors to develop the drug. He met Dr. Hung, who had already succeeded with a previous company, and Medivation was set up. Medivation in turn licensed rights to Dimebon to Pfizer for a large initial payment of $225 million. Pfizer already sells Aricept, a leading drug for Alzheimer’s, but that product will be losing patent protection later this year. Shares of Pfizer fell 28 cents, or about 1.6 percent, to $17.32. Medivation and Pfizer are conducting additional trials in which Dimebon is being combined with other Alzheimer’s drugs. |
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