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Medivation Reports Year-End 2007 Financial Results and Pipeline Progress

SAN FRANCISCO, Feb. 19 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its financial results and pipeline progress for the year ended December 31, 2007.

"In 2007 we continued our track record of milestone achievement to advance development across our entire portfolio, and we are pleased to enter 2008 with an Alzheimer's disease product candidate in confirmatory Phase 3 development," said David T. Hung, M.D., president and chief executive officer of Medivation. "We remain committed to the rapid, efficient development of our novel product candidates for Alzheimer's disease, Huntington's disease and hormone-refractory prostate cancer to make them available to people around the world who are increasingly afflicted with these deadly and debilitating diseases for which there are still very few treatment options."

Recent Accomplishments

Alzheimer's Disease

-- Completed a double-blinded, placebo-controlled twelve month extension

of our first pivotal Alzheimer's disease (AD) trial, in which patients

continued to show statistically significant benefits on all five

clinical endpoints studied;

-- Completed a comprehensive Phase 1 clinical development program in the

U.S., which continued to show Dimebon to be safe and well tolerated;

-- Completed a successful end-of-Phase 2 meeting with the U.S. Food and

Drug Administration, which recognized our previously completed AD trial

as pivotal and allowed us to proceed to a confirmatory pivotal Phase 3


Huntington's Disease

-- In collaboration with the Huntington Study Group, began a randomized,

double-blinded, placebo-controlled Phase 1-2 trial in Huntington's

disease patients;

-- Completed the Phase 1 portion of the trial, in which Dimebon was safe

and well tolerated, and the Phase 2 portion remains ongoing;

Hormone-Refractory Prostate Cancer

-- Began an open-label Phase 1-2 clinical trial in hormone-refractory

prostate cancer patients;

-- Reported early, positive data showing encouraging, dose-dependent

reductions in serum prostate-specific antigen (PSA) in our two lowest

dosing groups;

-- Based on these results, received approval to expand the size of the

trial and now expect to enroll approximately 100 patients, including

both chemotherapy naive patients as well as patients who have failed

prior chemotherapy;

Strengthened Management Team and Financial Position

-- Appointed Rohan Palekar, a 16-year marketing executive from Johnson &

Johnson's Centocor division as chief commercial officer to lead

commercialization activities for all of our product candidates;

-- Promoted Michele Bronson, Ph.D., to vice president of regulatory

affairs, to represent Medivation programs to U.S. and international

regulatory agencies, develop regulatory strategies and oversee quality

and project management; and,

-- Entered into a $100 million committed equity line of credit facility

with Azimuth Opportunity, Ltd., which provides access to committed

capital at times and in amounts of Medivation's choosing.

2007 Financial Results and 2008 Financial Outlook

Medivation reported a net loss of $31.7 million for the year ended December 31, 2007, compared to a net loss of $15.4 million in the prior year. The basic and diluted loss per share for 2007 was $(1.14) on 27.9 million weighted average common shares outstanding compared to a basic and diluted loss per share of $(0.63) on 24.2 million weighted average common shares outstanding for 2006.

Total operating expenses increased to $33.8 million for the year ended December 31, 2007, from $16.1 million for the same period in 2006.

Medivation ended 2007 with $43.3 million in cash and equivalents, plus a remaining capacity of $78.8 million under its committed equity line of credit facility. The Company expects total operating expenses in 2008 to increase significantly beyond 2007 levels, due primarily to further expansion of Dimebon and MDV3100 development, including the upcoming confirmatory pivotal Phase 3 trial of Dimebon in AD and the expanded dosing groups in the ongoing Phase 1-2 trial of MDV3100 in HRPC.

2008 Corporate Milestones

"In 2008, we plan to begin multiple AD clinical trials for Dimebon, including our confirmatory pivotal Phase 3 trial. We also look forward to presenting a steady stream of data across all of our programs in 2008 -- including top-line results from our ongoing Phase 2 trials in Huntington's disease and hormone-refractory prostate cancer," continued Dr. Hung.

During 2008 Medivation intends to:

-- Initiate a second, confirmatory pivotal Phase 3 trial of Dimebon in AD

in the second quarter with the goal of completing the trial and

applying for U.S. and European marketing approval in 2010.

-- Conduct multiple clinical trials of Dimebon in AD for marketing and

reimbursement purposes and to provide a safety database of

approximately 1,500 patients as part of its marketing application. In

the second quarter of 2008, the Company plans to begin the first of

these trials -- a 20 patient Phase 1 trial to evaluate the safety and

tolerability of Dimebon when given to AD patients who are also taking

Aricept(R), the leading AD treatment on the market.

-- Complete the ongoing Phase 2 study of Dimebon in Huntington's disease

in the second quarter.

-- Begin global Phase 3 clinical studies in Huntington's disease if the

results of the ongoing Phase 2 clinical trial are supportive.

-- Report additional follow-up data from the first pivotal trial of

Dimebon in AD.

-- Report data on Dimebon's novel mechanism of action.

-- Complete the ongoing Phase 1-2 clinical trial of MDV3100 in HRPC.

About Medivation

Medivation, Inc. is a biopharmaceutical company with small molecule drugs in clinical development to treat three large, unmet medical needs -- Alzheimer's disease, Huntington's disease and hormone-refractory prostate cancer. The Company's strategy is to identify promising product candidates, to develop them in a rapid, cost-effective manner, and to seek development and/or commercialization partners as appropriate to complement its internal efforts. For more information, please go to

This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. None of the Company's product candidates has been approved for sale, significant additional animal and human testing is required in order to seek marketing approval for any of its product candidates, and Medivation cannot assure you that marketing approval can be obtained for any of its product candidates. Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of Medivation's preclinical and clinical data, so its views remain subject to change. Medivation's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2007, include information about additional factors that could affect the Company's financial and operating results.

- financial statements to follow -




December 31, 2007


Current assets:

Cash and cash equivalents $43,258,479

Prepaid expenses and other current assets 990,909

Total current assets 44,249,388

Property and equipment (net of accumulated depreciation and

amortization of $69,474) 688,743

Intellectual property (net of accumulated amortization

of $16,673) 58,327

Other non-current assets 599,601

Total assets $45,596,059


Current liabilities:

Accounts payable $3,884,995

Other current liabilities 149,777

Total current liabilities 4,034,772

Other non-current liabilities 492,109

Series A redeemable preferred stock 11,000

Total liabilities 4,537,881

Commitments and contingencies

Stockholders' equity:

Preferred stock, $0.01 par value per share;

1,000,000 shares authorized; no shares issued and outstanding -

Common stock, $0.01 par value per share;

50,000,000 shares authorized; 28,837,290 shares issued and

outstanding 288,372

Additional paid-in capital 100,969,362

Deficit accumulated during the development stage (60,199,556)

Total stockholders' equity 41,058,178

Total liabilities and stock and stockholders' equity $45,596,059





Year ended December 31, (September 4, 2003)

2007 2006 to December 31, 2007

Operating expenses:

General and administrative:

Payroll * $2,819,931 $937,677 $4,647,224

Consulting and other

professional fees * 4,086,689 1,964,819 7,952,822

Other general and

administrative 2,222,262 911,638 4,251,064

Total general and

administrative 9,128,882 3,814,134 16,851,110

Research and development:

Payroll * 5,321,212 1,358,735 7,693,780

Consulting and other

professional fees * 3,869,029 2,306,660 8,316,550

Preclinical and clinical

studies 14,088,491 8,405,044 26,658,806

Other research and

development 1,355,332 261,520 1,981,103

Total research and

development 24,634,064 12,331,959 44,650,239

Total operating expenses 33,762,946 16,146,093 61,501,349

Loss from operations (33,762,946 (16,146,093) (61,501,349)

Other income (expense):

Interest income 2,022,361 785,016 2,938,459

Warrants issued to related

party guarantors - - (17,505)

Liquidated damages expense:

To related parties - - (1,102,530)

To other parties - - (507,900)

Total other income

(expense) 2,022,361 785,016 1,310,524

Loss before provision for

income taxes (31,740,585) (15,361,077) (60,190,825)

Provision for income taxes 2,400 2,331 8,731

Net loss $(31,742,985) $(15,363,408) $(60,199,556)

Basic and diluted net loss per

share: $(1.14) $(0.63)

Weighted average common shares

outstanding used in the

calculation of basic and

diluted net loss per share 27,932,309 24,247,522

* Includes non-cash stock-based compensation expense.

SOURCE Medivation, Inc.
Copyright©2008 PR Newswire.
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