| Medivation Inc.'s (MDVN) investigational Alzheimer's drug Dimebon has surprised researchers again at the 2009 International Conference on Alzheimer's disease.
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| | | | | Researchers who are still not clear how Dimebon works were in for yet another surprise when they found that treatment with Dimebon caused an increase in a brain protein, known as beta amyloid, in animal models of Alzheimer's. Beta amyloid is the main constituent of plaques found in the brains of people with Alzheimer's and is thought to be a key player in the development and progression of the disease. Dimebon, which is being developed in partnership with Pfizer Inc. (PFE), is currently under phase III testing in patients with mild-to-moderate Alzheimer's disease. The study dubbed CONNECTION is a six-month trial that has enrolled 598 patients, exceeding the enrollment target of 525 patients. More than 40% of the patients enrolled were in the United States. The study is evaluating the effect of Dimebon on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change plus caregiver interview (CIBIC-plus) -- the two endpoints have historically been accepted by the FDA to support registration of currently approved drugs for mild-to-moderate Alzheimer's disease. Till date, there has been no cure for Alzheimer's. The FDA-approved drugs, which are currently in the market, can temporarily relieve only some symptoms of the disease like, memory loss, difficulty in communicating, impaired judgment and a loss of initiative. Forest Laboratories Inc.s' (FRX) Namenda, Sciele Pharma Inc.'s (SCRX) Cognex, Pfizer/Eisai's Aricept, Novartis AG's (NVS) Exelon, and Janssen-Ortho Inc.'s Razadyne can alleviate the symptoms of Alzheimer's like memory deterioration. With growing unmet medical need, therapeutic opportunities for Alzheimer's drug developers are still wide open. The global Alzheimer's drug market, which was worth about $500 million in 1999 increased to over $6 billion in 2008, according to reports. According to the results of a first phase III study conducted in Russia, the results of which were published in the medical journal, Lancet, last year, patients with mild-to-moderate Alzheimer's disease treated with Dimebon, experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function. After both six months and a full year of treatment, Dimebon-treated patients were significantly better than placebo-treated patients on all key aspects of the disease. Under the global agreement inked with Pfizer in September 2008, Medivation is conducting a broad Dimebon clinical development program that includes several phase III trials assessing the efficacy and safety of the drug taken alone or in combination with other Alzheimer's medications in patients with mild, moderate or severe Alzheimer's disease. Medivation received an up-front cash payment of $225 million last October as per the terms of the deal and is also eligible to receive up to $500 million in development milestones plus additional undisclosed commercial milestones based on global net sales. The development expenses, profits and losses will be shared by Pfizer and Medivation on a 60:40 basis. According to Medivation, Dimebon works by targeting mitochondria. The New Drug Application filing for Dimebon is currently targeted for 2011. In addition, a phase I-II clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer is currently underway. The phase I-II trial of MDV3100 has demonstrated anti-tumor activity in both chemotherapy-naive and post-chemotherapy CRPC (castration-resistant prostate cancer) patients across dose levels and endpoints, as evaluated by reductions in prostate specific antigen levels, radiographic findings and circulating tumor cell counts. A phase III trial of MDV3100 is expected to begin this year. Shares of MDVN have gained nearly 65% from their March low of $14.11 and currently trade around $23.
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