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Medivation Reports Second Quarter 2008 Financial Results and Provides Corporate Update

- Conference Call Today at 4:30 p.m. Eastern Time -

SAN FRANCISCO, Aug. 11 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its corporate progress and financial results for the quarter ended June 30, 2008.

"Based on the significant findings of the Dimebon 12-month pivotal trial in Alzheimer's disease recently published in The Lancet, as well as the promising results from our Phase 2 study in Huntington's disease announced last month, we believe Dimebon is among the most promising drug candidates being investigated today to treat patients with debilitating, and ultimately fatal, neurodegenerative diseases," said David Hung, M.D., president and chief executive officer of Medivation. "We are making excellent progress opening U.S. sites and enrolling patients in our confirmatory Phase 3 trial of Dimebon in Alzheimer's disease, and remain on target to complete the study in time to file for U.S. marketing approval for Alzheimer's disease in 2010. In addition, we continue to increase the dose and enroll patients in our ongoing Phase 1-2 study of MDV3100 for castration-resistant prostate cancer. We remain on track for completing that study later this year, after which we intend to seek FDA approval to enter Phase 3 in 2009."

Second Quarter Highlights and Recent Accomplishments

Alzheimer's Disease

-- Initiated dosing of patients in a second pivotal Phase 3 trial of the

investigational drug Dimebon in patients with mild-to-moderate

Alzheimer's disease. This international, double-blind,

placebo-controlled safety and efficacy study of oral Dimebon, known as

the CONNECTION study, will enroll approximately 525 patients at 60 to

80 clinical sites in the U.S., Europe and South America.

-- Published results of the first pivotal clinical trial of Dimebon in the

July 19, 2008 issue of The Lancet. The article highlighted that

patients with mild-to-moderate Alzheimer's disease treated with Dimebon

experienced statistically significant improvements compared to placebo

on all of the key aspects of the disease -- memory and thinking,

activities of daily living, behavior and overall function -- over a

12-month period.

-- Presented new Dimebon data at three presentations at the 2008

Alzheimer's Association International Conference on Alzheimer's

Disease (ICAD):

-- Presented results from a six-month, open-label extension of the

12-month placebo-controlled study showing that Dimebon continued

to improve the clinical course of the disease. After 18 months

of treatment, Dimebon preserved function in patients at or near

their original levels upon entering the trial across all key

aspects of Alzheimer's disease. Dimebon remained well tolerated

throughout the 18-month treatment period.

-- Presented new 12-month data from subgroup analyses by disease

severity of the first pivotal trial showing that Dimebon

benefited both mild and moderate patients, resulting in

significant benefit on the study's primary endpoint, the

Alzheimer's Disease Assessment Scale-cognitive subscale

(ADAS-cog). The drug-placebo difference in moderate patients

was 9.7 ADAS-cog points after 12 months of Dimebon treatment.

-- Presented new preclinical data at a podium presentation on

Dimebon's novel mechanism of action, showing that Dimebon

improves mitochondrial function in the setting of cellular

stress with very high potency. Mitochondria, which generate

energy for cells and play important roles in mediating cell

function and survival, have been associated with both

Alzheimer's and Huntington's diseases in the published


-- Successfully completed a thorough QTc cardiac safety study of Dimebon.

In this study, Dimebon was well tolerated and did not produce any

cardiac safety issues. The U.S. Food and Drug Administration requires

thorough QTc studies for all new drugs undergoing regulatory approval.

Huntington's Disease

-- Announced top-line results of a Phase 2 study showing that Dimebon was

well tolerated and significantly improved cognitive function in

patients with mild-to-moderate Huntington's disease compared to those

treated with a placebo. Medivation intends to submit results from the

Phase 2 study for presentation at an upcoming scientific meeting, and

to seek FDA approval to begin a Phase 3 Huntington's disease study in


Castration-Resistant Prostate Cancer

-- Presented data at the American Society of Clinical Oncology 2008 Annual

Meeting from the ongoing Phase 1-2 study showing that MDV3100 was

associated with encouraging anti-tumor activity as measured by

declining serum levels of prostate specific antigen (PSA) and

circulating tumor cells (CTC), as well as radiographic disease

stabilization, after three months of treatment.

-- Obtained IRB approval to add two higher dose groups (480 mg and 600 mg)

to the ongoing Phase 1-2 study, increasing the total number of dose

groups from five to seven.

-- Began dosing patients in the 360 mg expansion cohort, which will

include up to 24 patients, and in the 480 mg dose escalation cohort,

which will include up to six patients. MDV3100 remains well tolerated

and a maximum tolerated dose has not yet been defined.

Second Quarter 2008 Financial Results

Medivation reported a net loss for the quarter ended June 30, 2008 of $18.5 million, or $0.64 per share, compared to a net loss of $7.2 million, or $0.26 per share, for the same period in 2007. For the six months ended June 30, 2008, the net loss was $34.1 million, or $1.18 per share, compared to a net loss of $12.8 million, or $0.46 per share, for the same period in 2007.

Total operating expenses for the three months ended June 30, 2008 were $18.7 million, compared to $7.7 million for the same period in 2007. The increase in operating expenses for the second quarter of 2008 compared to the same period in 2007 is primarily due to increased development costs associated with the Company's lead investigational products, Dimebon and MDV3100, currently in clinical trials.

For the six months ended June 30, 2008, total operating expenses were $34.6 million, compared to total operating expenses of $13.9 million for the same period in 2007. These figures include non-cash stock-based compensation expense of $4.2 million in the six months ended June 30, 2008 compared to $2.6 million for the same period in 2007. Medivation expects that total operating expenses in 2008 will be in the range of $65 million to $75 million, excluding stock-based compensation expense. The increase from prior guidance is due primarily to increased manufacturing and clinical development costs to support the expansion of the Company's ongoing and upcoming clinical trials.

Cash and cash equivalents at June 30, 2008 totaled $33.4 million, compared to $43.3 million at December 31, 2007 and $32.9 million at March 31, 2008. During the second quarter of 2008, the Company raised approximately $15 million in net proceeds from the sale of shares to existing institutional investors. At June 30, 2008 the remaining capacity under Medivation's committed equity line of credit with Azimuth Opportunity, Ltd. was $78.8 million. The Company may draw on that remaining capacity at its discretion during the term of the facility, which expires on April 1, 2009.

Conference Call Information

To participate in today's live call beginning at 4:30 p.m. Eastern Time by telephone, please call 877-397-0286 from the U.S. or +1-719-325-4901 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 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. The Company's current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer's disease and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. Medivation recently announced that it plans to continue further development of Dimebon in patients with mild-to-moderate Huntington's disease based on the positive results seen in its Phase 2 trial. For more information, please visit us at

This press release contains forward-looking statements, including statements regarding 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, 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 today 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.




(In thousands, except per share data)






Three Months Ended Six Months Ended 4, 2003)

June 30, June 30, to June

2008 2007 2008 2007 30, 2008

Operating expenses:

Research and

development $14,258 $5,257 $26,214 $9,509 $68,553

General and

administrative 4,457 2,407 8,410 4,357 27,572

Total operating

expenses 18,715 7,664 34,624 13,866 96,125

Loss from operations (18,715) (7,664) (34,624) (13,866) (96,125)

Other income (expense):

Interest and other

income 184 504 565 1,062 3,504

Other expense (12) - (14) (3) (1,652)

Total other

income (expense) 172 504 551 1,059 1,852

Net loss $(18,543) $(7,160) $(34,073) $(12,807) $(94,273)

Basic and diluted net

loss per share $(0.64) $(0.26) $(1.18) $(0.46)

Weighted average common

shares used in the

calculation of basic and

diluted net loss per

share 28,943 27,785 28,895 27,765




(in thousands, except share and per share data)


June 30, December 31,

2008 2007


Current assets:

Cash and cash equivalents $33,434 $43,258

Prepaid expenses and other current

assets 2,321 991

Total current assets 35,755 44,249

Property and equipment, net 739 689

Intellectual property, net 56 58

Other non-current assets 1,254 600

Total assets $37,804 $45,596


Current liabilities:

Accounts payable $3,889 $1,747

Accrued expenses 7,101 2,218

Other current liabilities 82 70

Total current liabilities 11,072 4,035

Other non-current liabilities 450 492

Series A redeemable preferred stock 11 11

Total liabilities 11,533 4,538

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


50,000,000 shares authorized;

issued and outstanding

30,004,998 shares at June 30, 2008

and 28,837,290 at December 31,

2007 300 288

Additional paid-in capital 120,244 100,970

Deficit accumulated during the

development stage (94,273) (60,200)

Total stockholders' equity 26,271 41,058

Total liabilities and stockholders'

equity $37,804 $45,596

SOURCE Medivation, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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