SAN FRANCISCO, May 10 /PRNewswire-FirstCall/ – Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the first quarter ended March 31, 2010.

“After thorough review of all available dimebon data, including the disappointing CONNECTION results, Medivation remains committed to determining whether dimebon may offer clinical benefit to Alzheimer’s and Huntington disease patients,” said David Hung, MD, president and chief executive officer of Medivation.  ”We will continue to enroll patients in the 12-month Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s patients and the six-month Phase 3 HORIZON study in Huntington disease, and will stop our two ongoing Phase 3 trials in moderate-to-severe Alzheimer’s disease.  In reaching this conclusion, we considered all dimebon data generated thus far, including the negative CONNECTION data, the clinical benefit seen in two prior dimebon trials in mild-to-moderate Alzheimer’s disease and Huntington disease, the excellent safety and tolerability profile in all dimebon trials to date covering more than 2,000 patients, the preclinical data consistently showing that dimebon is pharmacologically active, and the potential risks and returns of continuing development for Alzheimer’s and Huntington diseases.  We believe both the CONCERT and HORIZON studies offer independent pathways to registration, and we will be meeting with the Food and Drug Administration this quarter to discuss the CONNECTION data and obtain guidance on our proposed regulatory path forward.”

“We also continue to make progress on our MDV3100 program,” continued Dr. Hung. “This year we and our partner Astellas expect to complete enrollment in the Phase 3 AFFIRM trial in advanced prostate cancer patients and to initiate three new trials in earlier-stage prostate cancer, including a second Phase 3 trial. Our cash position remains strong and, based on current assumptions, we expect our cash to last beyond 2012, without regard to whether Pfizer elects to remain in our dimebon collaboration.  We also expect to have reported top-line data from the CONCERT, HORIZON and AFFIRM trials by the end of 2012.”

Recent Accomplishments and Anticipated Milestones

Dimebon (latrepirdine*)

• Completed an analysis of data from the Phase 3 CONNECTION trial in patients with mild-to-moderate Alzheimer’s disease, and confirmed that dimebon did not show clinical benefit in this trial. The analysis did not identify any systematic issues with the conduct of the trial or with the drug product that would explain the results.
• Continued to enroll patients in CONCERT, with the goal of completing patient accrual in 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.
• Continued to enroll patients in HORIZON, with the goal of completing patient accrual in 2010. This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition in patients with Huntington disease.
• Agreed with our partner Pfizer to discontinue the CONSTELLATION and CONTACT Phase 3 trials in patients with moderate-to-severe Alzheimer’s disease. These trials were part of a label expansion strategy for dimebon, which can be revisited at a later time if the results of the ongoing CONCERT trial warrant.

*Latrepirdine is the proposed generic name for dimebon.

MDV3100

• Announced publication in The Lancet of positive efficacy data from the Phase 1-2 trial of MDV3100 in advanced prostate cancer patients. MDV3100 demonstrated anti-tumor activity as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts.  MDV3100 was generally well-tolerated in this trial at doses up to and including 240 mg/day.
• Continued to enroll patients in the AFFIRM trial, with the goal of completing patient accrual in 2010. This randomized, double-blind, placebo-controlled Phase 3 survival trial is evaluating 160 mg/day of MDV3100 in men with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
• Obtained issuance of a U.S. patent claiming MDV3100′s composition of matter.  The term of this patent runs through 2027, and under current law is eligible for up to five years’ patent term extension based on time spent pursuing regulatory approval to market MDV3100.
• On track to initiate three new MDV3100 trials in earlier-stage prostate cancer this year: a Phase 3 trial in men with chemotherapy-naive castration-resistant prostate cancer; a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 1 trial in hormone-naive patients. Initiation of the Phase 3 trial would trigger a $10 million milestone payment under our collaboration agreement with Astellas.

Corporate

• Implemented a 20 percent workforce reduction to focus resources on the prioritized CONCERT and HORIZON dimebon trials and expanded development of MDV3100.

First Quarter 2010 Financial Results

Revenue for the first quarter of 2010 was $15.7 million, consisting of partial recognition of the non-refundable up-front payments of $225.0 million received from Pfizer in the fourth quarter of 2008 and $110.0 million received from Astellas in the fourth quarter of 2009. Both up-front payments were recorded as deferred revenue upon receipt and are being recognized on a straight-line basis over the estimated performance period of the Company’s obligations under the applicable collaboration agreement, which the Company presently expects to complete in the second quarter of 2013 for the Pfizer collaboration and in the fourth quarter of 2014 for the Astellas collaboration.

For the three months ended March 31, 2010, total operating expenses were $33.4 million, compared with total operating expenses of $22.1 million for the same period in 2009.  These figures include non-cash stock-based compensation expense of $3.5 million in the quarter ended March 31, 2010, compared with $2.6 million for the same period in 2009.

Beginning in October 2008, Pfizer became responsible for 60 percent of all dimebon-related development and commercialization costs in the U.S., and 100 percent of such costs outside the U.S.  Beginning in October 2009, Astellas became responsible for 50 percent of all MDV3100-related development and commercialization costs in the U.S. (other than costs for clinical trials supporting development in both the U.S. and either Europe or Japan, including the ongoing Phase 3 AFFIRM trial and the two additional trials in earlier-stage prostate cancer we expect to initiate in 2010, which are borne two-thirds by Astellas and one-third by Medivation) and 100 percent of such costs outside the U.S.  The parties make quarterly true-up payments as necessary to ensure that each bears its applicable share of costs.  For the first quarter of 2010, the net true-up payments payable to Medivation were $4.6 million and $6.1 million under the Pfizer and Astellas collaborations, respectively.  Medivation presents these cost-sharing true-up payments in the applicable expense line of its consolidated statement of operations.

Medivation reported a net loss for the quarter ended March 31, 2010, of $17.5 million, or $0.51 per share, compared with a net loss of $5.6 million, or $0.19 per share, for the same period in 2009.

Cash, cash equivalents and short-term investments at March 31, 2010, totaled $255.5 million, compared with $278.2 million at December 31, 2009.

2010-12 Financial Outlook

Medivation currently expects that total operating expenses for 2010, net of cost-sharing payments from Pfizer and Astellas, will be between $105 and $115 million.  This forecast includes approximately $13.5 million of non-cash stock-based compensation expense.  We also expect to receive a $10 million milestone payment from Astellas in 2010 upon initiation of the second Phase 3 study of MDV3100.

Medivation believes that its existing cash resources are adequate to fund its currently budgeted operations beyond 2012, without regard to whether Pfizer elects to remain in the dimebon collaboration.  By the end of 2012, the Company expects to have reported top-line data from the CONCERT trial in mild-to-moderate Alzheimer’s disease, the HORIZON trial in Huntington disease, and the AFFIRM trial in castration-resistant prostate cancer patients who have failed chemotherapy.

Conference Call Information

To participate by telephone in today’s live call beginning at 4:30 p.m. Eastern Time, please call 877-303-2523 from the U.S. or +1-253-237-1755 internationally.  In addition, the live conference call is being webcast and can be accessed on the “Events and Presentations” page of the “Investor Relations” section of the Company’s website at www.medivation.com.  A replay also will be available for 30 days following the live call.

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 announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases.  With Pfizer, Medivation is conducting a clinical development program that includes CONCERT, a Phase 3 trial assessing dimebon in patients with mild-to-moderate Alzheimer’s disease, and HORIZON, a Phase 3 trial of dimebon in Huntington disease.  In October 2009, Medivation entered into a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for both early- and late-stage prostate cancer.  The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy.  Additional trials in earlier-stage prostate cancer will begin in 2010.  For more information, please visit us at www.medivation.com.

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The Dimebon Plus Aricept Combination Will Become Decision Resources’ Proprietary Clinical Gold Standard for the Treatment of Moderate to Severe Alzheimer’s Disease in 2013

WALTHAM, Mass., Feb. 17, /PRNewswire/ – Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of moderate to severe Alzheimer’s disease, a combination therapy that delays nursing home admission at 19 months would earn 43 percent patient share, according to surveyed U.S. neurologists. In comparison, in Europe, such an agent would earn a slightly lower patient share of 30 percent, according to surveyed European neurologists. This lower share estimate is possibly a result of higher price sensitivity of European markets.

The new report entitled Alzheimer’s Disease (Moderate to Severe): Significant Opportunity Awaits Novel Agents Offering Only Incremental Efficacy and Delivery Advantages also finds that the Pfizer/Medivation’s Dimebon plus donepezil (Eisai/Pfizer’s Aricept, Bracco’s Memac) combination earns Decision Resources’ proprietary clinical gold-standard status for the treatment of moderate to severe Alzheimer’s disease in 2013, following Dimebon’s approval for Alzheimer’s disease in 2012. The Dimebon/donepezil combination has competitive advantages in efficacy—including effect on cognition, the highest-weighted efficacy outcome by surveyed neurologists—over the current gold standard combination donepezil plus memantine (Merz/Grupo Grunenthal’s Axura/Akatinol, Lundbeck’s Ebixa, Forest Laboratories’ Namenda).

“Surveyed neurologists say that a therapy’s effect on cognitive decline is the attribute that most influences their prescribing decisions in moderate to severe Alzheimer’s disease,” stated Decision Resources Analyst Matthew Winton, Ph.D. “Clinical data and the opinions of interviewed thought leaders indicate that the Dimebon plus donepezil combination has advantages over the sales-leading memantine plus donepezil combination on this attribute.”

About the Report

Alzheimer’s Disease (Moderate to Severe): Significant Opportunity Awaits Novel Agents Offering Only Incremental Efficacy and Delivery Advantages is a DecisionBase 2010 report. DecisionBase 2010 is a decision-support tool that provides in-depth analysis of unmet need, physician expectations of new therapies and commercial dynamics to help pharmaceutical companies optimize their investments in drug development.

About Decision Resources

Decision Resources (www.DecisionResources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

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– Medivation to Receive $110 Million Upfront Cash Payment and Eligible to Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and Double-Digit Royalties on Ex-U.S. Sales — – Medivation to Host Conference Call/Webcast Today at 8:30 a.m. Eastern Time –

TOKYO and SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ — Astellas Pharma Inc. (“Astellas”) and Medivation, Inc. (Nasdaq: MDVN) announced today that they have entered into a global agreement to develop and commercialize MDV3100, Medivation’s investigational drug for the treatment of prostate cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

Under the terms of the agreement, Medivation will receive an up-front cash payment of $110 million. Medivation is also eligible to receive payments of up to $335 million upon the attainment of development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. The companies will share equally all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales.

“We are pleased to initiate a great partnership with Medivation,” stated Masafumi Nogimori, president and chief executive officer of Astellas. “We believe that MDV3100 has the unique potential to establish a new treatment approach for prostate cancer. Astellas already has the global expertise in urology and the strong commitment to focus on oncology. This partnership is a significant milestone to further expand our business in urology and to establish our franchise in oncology.”

“We are excited to be working with Astellas to develop MDV3100 for a broad spectrum of prostate cancer disease states,” said David Hung, M.D., president and chief executive officer of Medivation. “Astellas is an ideal partner for MDV3100 given its global reach, leading commercial presence in the urology space, and strategic focus on oncology. Astellas is the second major collaboration we have completed in the past year, and we are confident we have the right partners in place for each of our late-stage programs–Astellas for MDV3100 and Pfizer, Inc for dimebon (latrepirdine*).”

According to the American Cancer Society, prostate cancer is the most common non-skin cancer among men in the United States. More than 2 million American men have prostate cancer, and it is the second leading cause of cancer death among men after lung cancer. In 2009, an estimated 192,000 new cases are expected to be diagnosed, and approximately 27,000 men are expected to die from the disease.

MDV3100, a new generation of oral anti-androgen, which shows different pharmacological profiles from current anti-androgens, has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and becomes effective immediately. Medivation’s legal and financial advisers on the transaction were Cooley Godward Kronish LLP and Aquilo Partners, L.P. Astellas’ legal adviser on the transaction was Covington & Burling LLP.

*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.

Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 888-280-4443 for domestic callers and 1-719-457-2638 for international callers. In addition, this call is being Webcast and can be accessed at Medivation’s website at www.medivation.com.

About MDV3100′s Clinical Program
In September 2009, Medivation began enrolling patients in a randomized, placebo-controlled, double-blind, multi-national Phase 3 clinical trial known as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally once daily versus placebo in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa.

Medivation previously announced interim safety and efficacy results from an ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that MDV3100 was associated with anti-tumor activity in patients who had become resistant to bicalutamide or other standard anti-androgen treatments, including both patients who had failed prior chemotherapy and patients who were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in prostate-specific antigen levels, improvement or stabilization in tumors that had spread to soft tissue or bone, and a decrease in circulating tumor cells, which has been associated in published literature with improved survival in patients with castration-resistant prostate cancer. MDV3100 was generally well tolerated in this trial at doses up to and including 240 mg/day, with fatigue being the most frequently reported adverse event.

About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 14,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology and Inflammatory, Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com.

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 announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer’s medications in patients with mild, moderate and severe Alzheimer’s disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. For more information, please visit us at http://www.medivation.com.

Medivation Forward Looking Statement
This press release contains forward-looking statements, including statements related to future clinical development of and ongoing clinical trials evaluating MDV3100, the therapeutic and commercial potential of MDV3100, and potential future development and regulatory milestone payments, commercial milestone payments and royalty payments under the agreement with Astellas, 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 the progress, timing and results of Medivation’s clinical trials, including the risk that positive results in earlier clinical trials may not be repeated in subsequent clinical trials and the risk that interim results from ongoing clinical trials may not be predictive of the final results of any such trial, enrollment of patients in Medivation’s clinical trials, difficulties or delays in obtaining regulatory approvals, Medivation’s dependence on Astellas for aspects of the development, regulatory approval, manufacturing and commercialization of MDV3100, manufacturing of MDV3100, competition with MDV3100 should it receive marketing approvals, 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 (SEC), including its quarterly report on Form 10-Q for the quarterly period ended June 30, 2009, filed with the SEC on August 5, 2009. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.

http://www.earthtimes.org/articles/show/astellas-and-medivation-enter-into,1015012.shtml

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Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and
Co-Commercialize MDV3100 for the Treatment of Prostate Cancer
– Medivation to Receive $110 Million Upfront Cash Payment and Eligible to
Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and
Double-Digit Royalties on Ex-U.S. Sales –

TOKYO and SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ — Astellas Pharma
Inc. (“Astellas”) and Medivation, Inc. (Nasdaq: MDVN) announced today that
they have entered into a global agreement to develop and commercialize
MDV3100, Medivation’s investigational drug for the treatment of prostate
cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical
trial in men with castration-resistant prostate cancer who were previously
treated with docetaxel-based chemotherapy.

Under the terms of the agreement, Medivation will receive an up-front cash
payment of $110 million. Medivation is also eligible to receive payments of
up to $335 million upon the attainment of development and regulatory
milestones plus up to an additional $320 million in commercial milestone
payments. The companies will collaborate on a comprehensive development
program that will include additional studies to develop MDV3100 for both late-
and early-stage prostate cancer. Subject to receipt of regulatory approval,
the companies will jointly commercialize MDV3100 in the U.S. The companies
will share equally all U.S. development costs, commercialization costs, and
profits. Astellas will have responsibility for developing and commercializing
MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties
on ex-U.S. sales.

“We are pleased to initiate a great partnership with Medivation,” stated
Masafumi Nogimori, president and chief executive officer of Astellas. “We
believe that MDV3100 has the unique potential to establish a new treatment
approach for prostate cancer. Astellas already has the global expertise in
urology and the strong commitment to focus on oncology. This partnership is a
significant milestone to further expand our business in urology and to
establish our franchise in oncology.”

“We are excited to be working with Astellas to develop MDV3100 for a broad
spectrum of prostate cancer disease states,” said David Hung, M.D., president
and chief executive officer of Medivation. “Astellas is an ideal partner for
MDV3100 given its global reach, leading commercial presence in the urology
space, and strategic focus on oncology. Astellas is the second major
collaboration we have completed in the past year, and we are confident we have
the right partners in place for each of our late-stage programs–Astellas for
MDV3100 and Pfizer, Inc for dimebon (latrepirdine*).”

According to the American Cancer Society, prostate cancer is the most common
non-skin cancer among men in the United States. More than 2 million American
men have prostate cancer, and it is the second leading cause of cancer death
among men after lung cancer. In 2009, an estimated 192,000 new cases are
expected to be diagnosed, and approximately 27,000 men are expected to die
from the disease.

MDV3100, a new generation of oral anti-androgen, which shows different
pharmacological profiles from current anti-androgens, has been shown in
preclinical studies to provide more complete suppression of the androgen
receptor pathway than bicalutamide, the most commonly used anti-androgen.
MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers
via three complementary actions – MDV3100 blocks testosterone binding to the
androgen receptor, impedes movement of the androgen receptor to the nucleus of
prostate cancer cells (nuclear translocation), and inhibits binding to DNA.
Preclinical data published in Science earlier this year demonstrated that
MDV3100 is superior to bicalutamide in each of these three actions.

The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 and becomes effective immediately. Medivation’s
legal and financial advisers on the transaction were Cooley Godward Kronish
LLP and Aquilo Partners, L.P. Astellas’ legal adviser on the transaction was
Covington & Burling LLP.

*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.

Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30
a.m. Pacific Time) to discuss this announcement. To participate in the
conference call, please dial 888-280-4443 for domestic callers and
1-719-457-2638 for international callers. In addition, this call is being
Webcast and can be accessed at Medivation’s website at www.medivation.com.

About MDV3100′s Clinical Program
In September 2009, Medivation began enrolling patients in a randomized,
placebo-controlled, double-blind, multi-national Phase 3 clinical trial known
as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally
once daily versus placebo in men with castration-resistant prostate cancer who
were previously treated with docetaxel-based chemotherapy. The primary
endpoint of the trial is overall survival; secondary endpoints include
progression-free survival, safety and tolerability. This trial is expected to
enroll approximately 1,200 patients at sites in the United States, Canada,
Europe, South America, Australia and South Africa.

Medivation previously announced interim safety and efficacy results from an
ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that
MDV3100 was associated with anti-tumor activity in patients who had become
resistant to bicalutamide or other standard anti-androgen treatments,
including both patients who had failed prior chemotherapy and patients who
were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in
prostate-specific antigen levels, improvement or stabilization in tumors that
had spread to soft tissue or bone, and a decrease in circulating tumor cells,
which has been associated in published literature with improved survival in
patients with castration-resistant prostate cancer. MDV3100 was generally well
tolerated in this trial at doses up to and including 240 mg/day, with fatigue
being the most frequently reported adverse event.

About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceuticals. Astellas has
approximately 14,000 employees worldwide. The organization is committed to
becoming a global category leader in Urology, Immunology and Inflammatory,
Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more
information on Astellas Pharma Inc., please visit our website at

http://www.astellas.com.

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 announced a global agreement
with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the
treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is
conducting a broad dimebon clinical development program that includes several
Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in
combination with other Alzheimer’s medications in patients with mild, moderate
and severe Alzheimer’s disease. The companies are also conducting a Phase 3
trial of dimebon in Huntington disease. In October 2009, Medivation entered a
global agreement with Astellas Pharma Inc. to develop and commercialize
MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100
development program, known as the AFFIRM trial, is under way in patients with
castration-resistant prostate cancer who have previously been treated with
docetaxel-based chemotherapy. For more information, please visit us at

http://www.medivation.com.

Medivation Forward Looking Statement
This press release contains forward-looking statements, including statements
related to future clinical development of and ongoing clinical trials
evaluating MDV3100, the therapeutic and commercial potential of MDV3100, and
potential future development and regulatory milestone payments, commercial
milestone payments and royalty payments under the agreement with Astellas,
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 the progress, timing and results of Medivation’s clinical trials,
including the risk that positive results in earlier clinical trials may not be
repeated in subsequent clinical trials and the risk that interim results from
ongoing clinical trials may not be predictive of the final results of any such
trial, enrollment of patients in Medivation’s clinical trials, difficulties or
delays in obtaining regulatory approvals, Medivation’s dependence on Astellas
for aspects of the development, regulatory approval, manufacturing and
commercialization of MDV3100, manufacturing of MDV3100, competition with
MDV3100 should it receive marketing approvals, 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 (SEC), including its quarterly report on
Form 10-Q for the quarterly period ended June 30, 2009, filed with the SEC on
August 5, 2009. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this press
release. Medivation disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press release.

SOURCE Medivation, Inc.

Patrick Machado, Chief Financial Officer of Medivation, +1-415-829-4101; or
Corporate Communications of Astellas Pharma Inc., +81-3-3244-3201, Fax:
+81-3-5201-7473

http://www.reuters.com/article/pressRelease/idUS121460+27-Oct-2009+PRN20091027

SAN FRANCISCO, Oct. 23 CA-Medivation-VP

SAN FRANCISCO, Oct. 23 /PRNewswire-FirstCall/ — Medivation, Inc. (Nasdaq: MDVN) today announced the appointment of Hank Mansbach, M.D., as vice president of medical affairs. Dr. Mansbach will lead Medivation’s medical affairs activities for dimebon (latrepirdine*), the company’s Phase 3 candidate for the treatment of Alzheimer’s and Huntington diseases, and MDV3100, which is in Phase 3 clinical development for the treatment of advanced prostate cancer.

“Hank brings a vast array of experience in a broad range of CNS therapeutic areas, and we are delighted to have him join the Medivation team,” said Rohan Palekar, chief commercial officer of Medivation. “With multiple Phase 3 trials ongoing with both dimebon and MDV3100, this is an excellent time for Hank to help deepen our relationships with the medical community and expand the visibility of our programs as we move towards commercialization.”

Dr. Mansbach is a neurologist with more than 10 years of strategic and operational drug development experience across all phases of development and multiple therapeutic areas. Prior to joining Medivation, he was senior vice president and head of global drug development at Valeant Pharmaceuticals, a specialty pharmaceutical company. At Valeant, among other programs, he led the development of retigabine, a novel epilepsy therapy which successfully completed Phase 3 trials in 2008 and was subsequently licensed to GlaxoSmithKline (GSK). From 2004 to 2006, Dr. Mansbach was chief medical officer and vice president for clinical development at Cortex Pharmaceuticals, an emerging biotechnology company developing novel CNS therapeutics. Dr. Mansbach began his industry career in the U.S. medical affairs department at GlaxoWellcome supporting the commercialization of Imitrex®/Imigran® and Lamictal® before taking on leadership roles in the GSK Neurosciences clinical development organization. While at GSK he worked on programs in migraine, stroke, epilepsy, multiple sclerosis, pain and Alzheimer’s disease.

Dr. Mansbach earned a medical degree from Duke University and a bachelor’s degree cum laude in philosophy from Yale University.

*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.

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 announced a global agreement with Pfizer Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer’s medications in patients with mild, moderate and severe Alzheimer’s disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. A Phase 3 clinical trial of MDV3100 in patients with castration-resistant prostate cancer is under way. For more information, please visit us at http://www.medivation.com.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com