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Medivation Presents New Data on Dimebon's Novel Mechanism of Action

SAN FRANCISCO, Dec. 9 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) presented new data that provide additional evidence that Dimebon, its lead product candidate in development to treat Alzheimer's and Huntington's diseases, potentially operates via a novel mitochondrial mechanism of action. In preclinical studies, Dimebon was shown to impact two key aspects of brain cell function: it promoted neurite outgrowth and it preserved mitochondrial function after brain cells were challenged with beta amyloid, a toxic substance often associated with Alzheimer's disease and the loss of brain cells.

"In experiments in which brain cells were exposed to different toxins, including beta amyloid, Dimebon was shown to stabilize mitochondrial function, a vital element of neuron function and survival," said Andrew Protter, Ph.D., vice president, preclinical development for Medivation. "These findings suggest that Dimebon may have benefits on slowing the progression of Alzheimer's disease by preserving mitochondrial function. This potential novel mechanism may help explain the clinical benefits seen to date in Alzheimer's patients treated with Dimebon."

Dr. Protter presented the new data in an oral presentation, entitled "Dimebon Induces Neurite Outgrowth and Stabilization in the Setting of Cell Stress," at Cold Spring Harbor Laboratory's "Neurodegenerative Diseases: Biology & Therapeutics" meeting.

Mitochondria and Cell Function

Mitochondria generate energy for cells and play important roles in mediating cell function and survival. Improved mitochondrial function has been correlated with increased synapse formation. Autopsy studies of brains from patients with Alzheimer's disease suggest that mitochondrial damage and synapse dysfunction are early cellular events in Alzheimer's disease development and progression. Similarly, mitochondrial dysfunction has been linked in the published literature to the progression of Huntington's disease.

Preclinical Study Results

As synapse formation is dependent on mitochondrial function and synapse loss is a major characteristic observed in the brain tissue of individuals with Alzheimer's disease, researchers evaluated the effects of Dimebon on neurite outgrowth, an important aspect of synapse formation.

Results of the study showed that Dimebon induced a statistically significant increase in neurite outgrowth from cortical, hippocampal and spinal cord neurons. Dimebon's potent effect on neurite outgrowth was seen at low concentrations and was comparable to that achieved with maximally effective concentrations of a potent growth factor (Brain Derived Neurotrophic Factor). Study results also showed that Dimebon reduced mitochondrial impairment in the setting of cellular stress. Specifically, Dimebon treatment mitigated mitochondrial impairment induced by beta amyloid.

Dimebon's effect on improving mitochondrial dysfunction has been confirmed previously in the independent laboratory of Maria Ankarcrona, Ph.D., associate professor at the Karolinska Institutet in Sweden. Additional data about Dimebon's potential novel mechanism of action were presented in November at the Society for Neuroscience's "Neuroscience 2008" conference in Washington, D.C.

Preclinical data also have been presented that suggest that Dimebon works through a different mechanism of action than other drugs that focus on targets implicated in cognition and memory loss, such as cholinesterase inhibition. In these experiments, Dimebon was shown to be a weak cholinesterase inhibitor, and additional data from binding assays showed that Dimebon did not have strong affinity to other standard targets. This suggests that Dimebon's potential novel mitochondrial mechanism of action may account for the clinical benefit observed in the Dimebon Alzheimer's and Huntington's disease clinical trials completed to date.

About Dimebon

Dimebon is an oral small molecule in development with Pfizer for Alzheimer's and Huntington's diseases. It is currently being evaluated in a second pivotal Phase 3 trial in Alzheimer's disease. Results from the first pivotal trial were published in the July 19, 2008, edition of The Lancet. A Phase 2 study in Huntington's disease was recently completed, and further development is planned in Huntington's disease.

About Medivation

Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. In September 2008, Medivation entered into a global agreement with Pfizer Inc to develop and commercialize Dimebon for the treatment of Alzheimer's and Huntington's diseases. With Pfizer, the Company is conducting a broad Dimebon clinical development program, including a pivotal and confirmatory Phase 3 trial, known as the CONNECTION study, in patients with mild-to-moderate Alzheimer's disease. The program also includes additional trials planned to begin next year in Alzheimer's disease, as well as further development of Dimebon in patients with mild-to-moderate Huntington's disease. In addition, a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer is ongoing. For more information, please visit us at

This press release contains forward-looking statements, including statements regarding the mechanism of action of Dimebon, the potential benefits of Dimebon as a treatment for Alzheimer's disease and Huntington's disease and future clinical development plans and milestones, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation's actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation's clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, including Medivation's collaborative relationship with Pfizer, manufacturing of Medivation's product candidates, competition with Medivation's product candidates should they receive marketing approval, the adequacy of Medivation's financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q filed on November 10, 2008, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.
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