Reuters: Hot Stocks: UPDATE 3-Merck Alzheimer drug reaches development milestone

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UPDATE 3-Merck Alzheimer drug reaches development milestone Dec 3rd 2012, 17:13 Mon Dec 3, 2012 12:13pm EST * MK-8931 first drug in new class to reach this stage of development * Blocks production of proteins thought to contribute to Alzheimer's * Lilly seen as frontrunner, but Merck trial could give equal footing * Merck shares up about 1 pct (Adds comments by Merck executive, updates stock prices) By Ransdell Pierson and Debra Sherman Dec 3 (Reuters) - Merck & Co Inc has started a new trial of its experimental Alzheimer's drug, the first mid-stage clinical trial of a promising new class of oral medicines that has the potential to shut down the production of a protein that many researchers believe is the primary cause of the disease. The drugmaker said on Monday it had started the trial to evaluate the safety and effectiveness of the drug, MK-8931, in patients with mild-to-moderate Alzheimer's disease. The Phase II trial, which will compare the drug with a placebo, is a global, multi-center study that includes a group of 200 patients to test safety. The study is expected eventually to enroll up to 1,700 patients in the main Phase III trial. Darryle Schoepp, head of neuroscience at Merck, said drugmakers have been trying for a decade to develop treatments that arrest Alzheimer's disease by blocking beta secretase, an enzyme involved in production of toxic beta amyloid proteins that form plaque in the brain believed to be a contributor to Alzheimer's disease. By blocking beta secretase in earlier Phase I trials, the Merck drug slashed by more than 90 percent the levels of beta amyloid protein circulating in cerebrospinal fluid. Schoepp said Merck's drug is the first medicine in the new class to reach this stage of development. "It's like shutting the faucet so nothing comes out," he said in an interview. "The hope is that by preventing production of beta amyloid - the building block of brain plaque - the Merck drug will prevent a worsening of symptoms among patients with mild-to-moderate stages of the disease." Should the Merck drug prove safe in the Phase II safety trials, he said the medicine could eventually be tested in "prodromal" patients, or those with the very earliest signs of Alzheimer's. They would include people with very mild memory problems who have also been shown by blood tests or brain scans to have worrisome initial buildup of amyloid plaque or who have other "bio markers" associated with the progressive memory-robbing disease. Schoepp said the Merck pill would be taken every morning, while Eli Lilly and Co's solanezumab is given by infusion at a hospital. He said the Lilly drug may leach away some of the amyloid brain plaque, rather than directly interfere with production of the beta amyloid proteins that form the plaque. "Our drug attacks the amyloid pathway directly. We're preventing it at the beginning. You can't get plaque if you don't make these" protein fragments, he said. A Lilly representative was not immediately available for comment. EQUAL FOOTING Lilly is considered the frontrunner in Alzheimer's research after solanezumab, in a Phase III trial, was shown in August to slow cognitive declines in patients with mild symptoms of Alzheimer's disease. However, the drug failed its overall goal of delaying cognitive and physical decline in patients with mild-to-moderate Alzheimer's. The start of Merck's new trial of MK-8931 could put the company on an equal footing with Lilly in the race for the first approved drug to delay the progress of the disease. Merck's drug appears almost to entirely prevent the formation of new beta amyloid, the toxic proteins that lead to plaques in the brain, while the Lilly drug acts by removing existing plaques, according to Mark Schoenebaum, an analyst with ISI Group. "We do not believe that Merck has any clinical efficacy data at this point upon which it is basing its Phase II/III 'go' decision. Thus, one must still view the Phase III as highly speculative," Schoenebaum wrote in a research note. Assuming the U.S. Food and Drug Administration asks Lilly to conduct another confirmatory Phase III trial on its drug, the Merck drug is on roughly the same timeline to potential approval as the Lilly drug, he said. If the FDA approves the Lilly drug on its existing data, something Schoenebaum thinks is unlikely, then Lilly would be about three years ahead, he added. Merck shares were up 0.9 percent at $44.70 on the New York Stock Exchange at midday, while Lilly shares were down 0.1 percent at $48.97. Earlier this year, Roche Holding AG more than doubled the size of a clinical trial of its experimental Alzheimer's drug, gantenerumab, in patients who have early Alzheimer's but have not yet developed dementia, putting it in the vanguard of attempts to catch the disease in early stages. A successful Alzheimer's treatment could reap billions of dollars in annual sales. But many experts believe treatment must be delivered before patients show signs of dementia because once that happens, brain damage may be irreversible. (Reporting by Debra Sherman in Chicago and Ransdell Pierson in New York; editing by Gerald E. McCormick, John Wallace and Matthew Lewis) Link this Share this Digg this Email Reprints

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