Earlier this month,
Medivation, Inc. (
MDVN) and
Pfizer, Inc. (
PFE) initiated two phase III studies, CONTACT and CONSTELLATION, with Dimebon in patients with moderate-to-severe Alzheimer's disease (AD). Dimebon is being developed in collaboration with Pfizer for the treatment of Alzheimer’s and Huntington diseases.
The CONTACT study will assess the potential benefits of adding Dimebon to ongoing treatment with Pfizer’s Aricept on neuropsychiatric symptoms and activities of daily living. Meanwhile, the CONSTELLATION study will evaluate the effects of adding Dimebon to
Forest Lab’s (
FRX) Namenda, another standard of care, on cognition, memory and activities of daily living.
Preclinical studies indicate that Dimebon has the potential to protect brain cells from damage and enhance brain cell survival, by stabilizing and improving mitochondrial function. Dimebon’s mechanism is distinct from currently available Alzheimer’s medications.
Dimebon is currently in seven studies which are evaluating the safety and efficacy of the candidate across all stages of Alzheimer's disease, both as monotherapy as well as in combination with currently available Alzheimer's treatments, and in Huntington disease.
Dimebon’s unique mechanism of action and efficacy seen in clinical trials could make it a significant player in the worldwide Alzheimer’s market, which represents huge commercial potential. It is estimated that the market is currently worth about $5 billion.
Dimebon has successfully completed the first of two pivotal trials required to gain marketing approval in the U.S. for mild-to-moderate Alzheimer’s disease. A second confirmatory phase III study, CONNECTION, is currently ongoing. We expect to see top-line results from this study in the first half of 2010. Positive results should allow Medivation to go ahead with the filing of the new drug application (NDA) for the Alzheimer’s indication in 2011.
We currently have a Neutral recommendation on Medivation.
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