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Medivation: further Phase II data supports Dimebon's clinical profile

Medivation has released new analysis from Dimebon's Phase II clinical trial, showing that the Alzheimer's disease drug decreases caregiver assistance time and improves activities of daily living. While this secondary endpoint analysis is not seen as pivotal to the drug's commercial viability, it does support Dimebon's clinical profile and serves as a confirmatory endpoint of clinical affect.

Dimebon is an orally-available, small molecule that is believed to block the mitochondrial permeability transition pore (MPTP), the glutamate NMDA receptor and cholinesterase activity. In new analysis released from Dimebon's Phase II trial, the drug significantly reduced caregiver assistance time (P=0.0004). By week 26 of the trial, caregivers were spending an average of 51 minutes less on activities of daily living (ADL) assistance during a typical day compared to caregivers of placebo-treated patients.

Similarly, the number of caregivers' hours/months was decreased in patients treated with Dimebon, but increased in patients treated with placebo (mean change from baseline, -9.3 hours vs. 12.3 hours, P=0.0024). In addition, Dimebon treatment resulted in a significant benefit vs. placebo in personal ADLs (0.9, P=0.0019 and 1.4, P=0.0149) and instrumental ADLs (1.8, P=0.0498) and (3.8, P=0.0056) at weeks 26 and 52, respectively.

In top-line results from this 183 patient Phase II clinical trial, conducted in Russia and released in June 2007, a statistically significant effect was reported on the studies primary endpoint, the ADAS-cog, a popular cognition clinical trial endpoint (6.9 point improvement at one year, p<0.0001).

Dimebon is about to enter Phase III clinical trials for mild-to-moderate Alzheimer's disease (AD). As an inhibitor of the MPTP, the glutamate NMDA receptor, and cholinesterase activity, Dimebon has the potential to be both disease slowing and symptomatic. The validity of the Phase II clinical trial referred to in this article has been questioned due to its conduction in Russia. However, the FDA has recently stated that it accepts this trial program as one of the two pivotal demonstrations of efficacy required for approval in the US.

In January 2008, Medivation stated that it expects to complete the pivotal Phase III trial and apply for marketing approval in 2010. Dimebon is expected to launch in 2011, by which time it is likely to face competition from Myriad's Flurizan and Wyeth/Elan's bapineuzumab, two further Phase III AD drugs with disease modifying potential. Although Dimebon has entered Phase III at a much later date than the other two drugs, the short six-month trial design will see it entering the market at approximately the same time as bapineuzumab and only one year behind Flurizan. Dimebon is forecasted to achieve a peak penetration rate of 20% in the US (16% in the 5EU and Japan), leading to sales revenue of $1.5 billion in the seven major markets in 2017.

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