SAN FRANCISCO, CA — (MARKET WIRE) — 11/09/11 — Medivation, Inc. (NASDAQ: MDVN) today provided a corporate update and reported its financial results for the third quarter ended September 30, 2011.

“The positive interim analysis results that we reported last week from our AFFIRM trial, in which MDV3100 produced a clinically meaningful and statistically significant 4.8-month increase in survival and a 37% reduction in risk of death in post-chemotherapy advanced prostate cancer patients, are an important step toward making this life-extending potential treatment available to the prostate cancer community,” said David Hung, M.D., president and chief executive officer of Medivation. “I am also pleased to announce that just yesterday the FDA granted us Fast Track designation for the post-chemotherapy indication, a designation that is reserved for development programs that the FDA determines to be for life-threatening conditions with unmet medical need. Our AFFIRM interim analysis data are clinically significant in this end-stage patient population, and increase the chance that MDV3100 may potentially demonstrate benefit in the much larger earlier-stage patient populations that we are currently studying in our ongoing clinical trials.”

“Based on the strength of these data, we have elected to exercise our co-promotion option to provide fifty percent of the U.S. sales force under our collaboration with Astellas,” continued Dr. Hung. “We will also provide fifty percent of the U.S. medical affairs support. This decision marks the potential transition of our company from a pure development organization to an integrated commercial organization, and we are actively planning for a successful launch of MDV3100 in post-chemotherapy patients should we receive marketing approval.”

Recent Accomplishments and Anticipated Milestones

MDV3100

• Announced the results of a pre-specified interim analysis in the Phase 3 AFFIRM trial, which is evaluating the effect of MDV3100 on overall survival in 1,199 men with advanced prostate cancer who have previously been treated with docetaxel-based chemotherapy. The data showed that MDV3100 produced a 4.8-month advantage in median overall survival compared to placebo, with median survival of 18.4 months in the MDV3100 group versus 13.6 months in the placebo group. MDV3100 also provided a 37% reduction in risk of death compared to placebo (hazard ratio = 0.631). The interim analysis results were statistically significant, with a p-value of less than 0.0001. A full analysis of the AFFIRM results, including safety data, will be submitted for presentation at an upcoming scientific congress.
• Based on the above results, the independent data monitoring committee (IDMC) overseeing the AFFIRM trial recommended that the study be stopped early and that all patients be offered MDV3100. The Company and its alliance partner Astellas expect to hold a pre-NDA meeting with the FDA in early 2012 and will provide an update on regulatory timelines for MDV3100 thereafter. Acceptance for filing of the NDA for the post-chemotherapy indication would trigger a $10 million milestone payment under Medivation’s collaboration agreement with Astellas.
• Received Fast Track designation from the FDA for MDV3100 in the post-chemotherapy indication. Receipt of Fast Track designation enables us to request the FDA grant us priority review for our anticipated NDA in post-chemotherapy patients. In considering requests for priority review, the FDA applies the same standard it uses to award Fast Track designation.
• Continued to enroll patients globally in the Phase 3 PREVAIL trial, which is evaluating the effect of MDV3100 on overall survival and progression-free survival in 1,700 men with advanced prostate cancer who have not yet received chemotherapy.
• Continued to enroll patients in the Phase 2 TERRAIN trial, which is comparing the effect of MDV3100 versus bicalutamide, the most commonly used anti-androgen, on progression-free survival in approximately 370 men with advanced prostate cancer who have progressed following medical castration with LHRH analog therapy or surgical castration.
• Continued to enroll patients in an open-label Phase 2 clinical trial designed to evaluate the effect of MDV3100 in 60 men with advanced prostate cancer who have not had any previous hormonal therapies. This trial marks the first step to determine whether MDV3100 can achieve comparable tumor control to LHRH analogs, as measured by prostate-specific antigen (PSA) response, while avoiding the negative quality of life impacts of castration.

Dimebon (latrepirdine)

• Remained on track to announce top-line results from the 12-month Phase 3 CONCERT trial in the first half of 2012. This trial completed enrollment in November 2010 with a total of 1,003 mild-to-moderate Alzheimer’s disease patients and is evaluating dimebon when added to ongoing treatment with donepezil, the leading approved treatment for mild-to-moderate Alzheimer’s disease.

Corporate

• Appointed Cheryl Cohen as chief commercial officer and Stewart Hallett as vice president, clinical operations.
• Exercised its co-promotion option for MDV3100 under the Astellas collaboration agreement. Should MDV3100 receive marketing approval, the Company will provide fifty percent of the sales and medical affairs field forces in support of MDV3100 in the United States.

Third Quarter 2011 Financial Results

Revenue for the third quarter of 2011 was $14.9 million, consisting of partial recognition of the non-refundable up-front and development milestone payments to date from the Company’s corporate partners Astellas and Pfizer. These payments were recorded as deferred revenue upon receipt and are being recognized as revenue on a straight-line basis over the estimated performance period of the Company’s obligations under the applicable collaboration agreement.

Total operating expenses for the third quarter were $26.4 million, compared with total operating expenses of $21.1 million for the same period in 2010. These figures include non-cash stock-based compensation expense of $3.2 million in the quarter ended September 30, 2011, compared with $3.3 million for the same period in 2010.

For the nine months ended September 30, 2011, total operating expenses were $76.4 million, compared with total operating expenses of $77.7 million for the same period in 2010. These figures include non-cash stock-based compensation expense of $10.5 million in the nine months ended September 30, 2011, compared with $10.0 million for the same period in 2010.

Medivation reported a net loss for the quarter ended September 30, 2011 of $10.0 million, or $0.29 per share, compared with a net loss of $5.4 million, or $0.16 per share, for the same period in 2010. For the nine months ended September 30, 2011, the net loss was $28.0 million, or $0.80 per share, compared with a net loss of $30.1 million, or $0.88 per share, for the same period in 2010.

Cash, cash equivalents and short-term investments at September 30, 2011 totaled $163.4 million, compared with $207.8 million at December 31, 2010.

2011 Financial Outlook

Medivation continues to expect total operating expenses for 2011, net of cost-sharing payments from Astellas and Pfizer, to be between $100.0 and $110.0 million. This forecast includes approximately $14.0 million of non-cash stock-based compensation expense.

http://investors.medivation.com/releasedetail.cfm?ReleaseID=622443

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Dimebon Dimebolin Information Availability

SAN FRANCISCO, Nov. 5, 2010 /PRNewswire-FirstCall/ — Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the third quarter ended September 30, 2010.

“In the third quarter, we began the expansion of our MDV3100 development program into earlier stage patients with the initiation of the Phase 3 PREVAIL trial, which is enrolling men with advanced prostate cancer who have not yet received chemotherapy.  Additionally, we believe that the positive interim analysis of the abiraterone Phase 3 study is a net positive for MDV3100, as it provides further clinical validation for the importance of the androgen receptor signaling pathway in advanced prostate cancer,” said David Hung, MD, president and chief executive officer of Medivation.  ”Together with our partner Pfizer, we continue to investigate dimebon’s potential clinical benefit in the ongoing Phase 3 HORIZON trial in Huntington disease and the ongoing Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s disease patients who are taking donepezil.  We remain on track to complete enrollment in the CONCERT trial this year and look forward to announcing top-line results from the HORIZON trial in the first half of 2011.”

Recent Accomplishments and Anticipated Milestones

MDV3100

• Initiated the Phase 3 PREVAIL trial evaluating MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy.  This randomized, double-blind, placebo-controlled, multi-national Phase 3 trial is expected to enroll approximately 1,700 patients globally.
• Continued to enroll patients in the AFFIRM trial and expect to complete patient accrual on November 15, 2010. This randomized, double-blind, placebo-controlled Phase 3 trial is evaluating MDV3100 in men with advanced prostate cancer who have been previously treated with docetaxel-based chemotherapy.
• On track to initiate two new MDV3100 trials in earlier-stage prostate cancer this year: a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 2 trial in hormone-naive patients.
• The Proceedings of the National Academy of Sciences (PNAS) published a paper showing the preclinical efficacy of MDV3100 against splice variants, which are mutated forms of the androgen receptor that may be associated with the development of prostate cancer resistance to hormone therapy.

Dimebon (latrepirdine)

• On track to report top-line data from HORIZON in the first half of 2011.  This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition and global function in patients with Huntington disease.

• Continued to enroll patients in CONCERT and expect to complete patient accrual on November 30, 2010.  This 12-month randomized, double-blind, placebo-controlled Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil.

Corporate

• Were awarded a $733,000 research and development grant under the Internal Revenue Service’s Therapeutic Discovery Project Credit Program.

Third Quarter 2010 Financial Results

Revenue for the third quarter of 2010 was $14.4 million, consisting of partial recognition of the non-refundable up-front payments to date from the Company’s corporate partners Pfizer and Astellas.  These payments were recorded as deferred revenue upon receipt and are being recognized as revenue on a straight-line basis over the estimated performance period of the Company’s obligations under the applicable collaboration agreement.

Total operating expenses for the third quarter of 2010 were $21.1 million, compared with $27.6 million for the same period in 2009.  These figures are net of cost-sharing payments from the Company’s corporate partners of $17.9 million and $4.2 million in the third quarters of 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $3.3 million and $2.5 million, respectively.

For the nine months ended September 30, 2010, total operating expenses were $77.7 million, compared with $73.8 million for the same period in 2009.  These figures are net of cost-sharing payments from the Company’s corporate partners of $41.5 million and $16.2 million in the nine months ended September 30, 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $10.0 million and $7.7 million, respectively.

Income tax benefit for the third quarter of 2010 was $1.5 million, compared with income tax expense of $2.8 million in the comparable period of 2009.  For the nine months ended September 30, 2010, income tax benefit was $1.5 million, compared with income tax expense of $4.5 million in the prior year period.

Medivation reported a net loss for the quarter ended September 30, 2010, of $5.4 million, or $0.16 per share, compared with a net loss of $14.0 million, or $0.42 per share, for the same period in 2009.  For the nine months ended September 30, 2010, the net loss was $30.1 million, or $0.88 per share, compared with a net loss of $28.5 million, or $0.90 per share, for the same period in 2009.

Cash, cash equivalents and short-term investments at September 30, 2010, totaled $211.5 million, compared with $278.2 million at December 31, 2009 and $233.3 million at June 30, 2010.

Financial Outlook

Medivation expects that its existing cash resources are adequate to fund its currently budgeted operations beyond 2012.  By the end of 2012, the Company expects to have reported top-line data from the Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s disease, the Phase 3 HORIZON trial in Huntington disease and the Phase 3 AFFIRM trial in advanced prostate cancer patients who have failed chemotherapy..

http://www.prnewswire.com/news-releases/medivation-reports-third-quarter-2010-financial-results-and-provides-corporate-update-106783688.html

Dimebon

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