Medivation (AMEX:MDV)
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Medivation, Inc. (AMEX:MDV) today announced that its
proprietary drug Dimebon(TM) met all five efficacy endpoints in a
six-month randomized, double-blinded, placebo-controlled Phase 2
clinical study of 183 patients with mild to moderate Alzheimer's
disease conducted at 11 sites in Russia. Compared with patients
receiving placebo, patients treated with Dimebon demonstrated highly
statistically significant improvement on the study's primary efficacy
endpoint, the Alzheimer's Disease Assessment Scale-cognition
(ADAS-cog; 4.0 point improvement in the mean change from baseline to
week 26 as compared to placebo; p less than 0.0001), and on the key
secondary efficacy endpoint, the Clinical Global Impression of Change
(CGIC; 0.6 point improvement in the mean change from baseline to week
26 as compared to placebo; p less than 0.0001). Dimebon-treated
patients also achieved statistically significant improvement (p less
than 0.01) compared with placebo patients on all three of the other
secondary efficacy endpoints - the Activities of Daily Living, the
Neuropsychiatric Inventory and the Mini Mental State Examination.
In addition to these improvements in comparison to placebo,
Dimebon-treated patients also showed statistically significant
improvement over baseline on all five efficacy endpoints used in this
study (p less than 0.05). By contrast, placebo-treated patients
deteriorated from baseline on all five endpoints.
Dimebon was well tolerated in this study. There were fewer serious
adverse events in Dimebon-treated patients than in placebo-treated
patients. No gastrointestinal side effects occurred in more than 3% of
the Dimebon-treated patients except for dry mouth, which occurred in
13.5% of the Dimebon-treated patients. A higher percentage of
Dimebon-treated patients than placebo-treated patients completed the
trial (87.6% and 81.9%, respectively), for an overall trial completion
rate of 84.7%.
Rachelle Doody, MD, PhD, Effie Marie Cain Chair, Director of the
Alzheimer's Disease and Memory Disorders Center at Baylor College of
Medicine, and a member of Medivation's Clinical and Scientific
Advisory Board, observed: "From my review of these rigorously
collected data, I believe the results are striking. It is very rare
for a Phase 2 Alzheimer's disease study to demonstrate significance on
all of the primary and secondary endpoints, five in this case, and
with strong statistical significance. I look forward to continued
collaboration with the Medivation team to further develop Dimebon as a
potential new therapy for Alzheimer's disease."
"We believe that these results are important, in part because the
primary and key secondary efficacy endpoints used in this trial are
accepted by the FDA for registration of drugs to treat mild to
moderate Alzheimer's disease," stated David Hung, MD, President and
Chief Executive Officer of Medivation. "In a meta-analysis of 10
randomized, double-blinded, placebo-controlled trials of approved
Alzheimer's disease drugs, published in 2006(1), treatment with these
drugs produced an average ADAS-cog improvement over placebo of 2.7
points. We thus believe that our results support continued, aggressive
pursuit of the further studies required to assess Dimebon's potential
safety and efficacy in treating Alzheimer's disease."
As the first step in its subsequent development plans, Medivation
today also announced that in the second quarter of 2006 it initiated a
double-blinded extension study which allows patients from the Phase 2
study to continue treatment for up to a total of 12 months in the same
treatment group to which they originally were randomized. Enrollment
in the extension study was 86% of eligible patients, and study results
are expected in the second quarter of 2007. Plans for further
Alzheimer's disease studies with Dimebon will be disclosed as they are
finalized.
"Given the encouraging results from the six-month trial, we are
delighted that such a large number of patients have elected to
continue treatment," noted Lynn Seely, MD, Chief Medical Officer of
Medivation. "The extension study will give us a unique opportunity to
investigate the effects of Dimebon compared with placebo at 12 months,
and also will provide longer term safety information to assist in
addressing regulatory requirements."
Dr. Hung concluded: "The Phase 2 data that we are announcing today
are an important step in validating Medivation's business model. We
secured our first equity financing less than two years ago, and to
date have used less than $20 million in funding our operations. With
that investment of time and cash, we have not only generated positive
results in a large Phase 2 Alzheimer's disease trial, but also
initiated new development programs in Huntington's disease and
hormone-refractory prostate cancer, both of which are scheduled to
enter the clinic in the next three quarters. We also remain committed
to finding new technologies to reach our targeted portfolio of four to
six programs."
Conference Call
Medivation will host a conference call today beginning at 1:00
p.m. Eastern time (10:00 a.m. Pacific time) to discuss the Phase 2
clinical trial results and to answer questions. To participate in the
live call by telephone, please dial (866) 271-5140 from the U.S. or
(617) 213-8893 from outside the U.S., and enter passcode 13594622.
Individuals interested in listening to the live call via webcast may
do so by visiting www.medivation.com.
A telephone replay will be available for 48 hours beginning
approximately two hours after the completion of the call by dialing
(888) 286-8010 from the U.S., or (617) 801-6888 from outside the U.S.,
and entering passcode number 13941286. A replay of the webcast will be
available on the company's web site for 30 days.
About Medivation
Medivation, Inc. acquires promising pharmaceutical and medical
device technologies in the late preclinical development phase, and
develops those technologies quickly and cost-effectively through human
first proof-of-efficacy studies (generally the end of Phase 2 clinical
trials). Depending on the indication, Medivation either will seek to
sell or partner successful programs with larger pharmaceutical,
biotechnology and medical device companies for late-stage clinical
studies and commercialization, or will conduct those activities
internally. The Company intends to build and maintain a portfolio of
four to six development programs at all times.
Medivation's current portfolio consists of small molecule drugs in
development to treat three large, unmet medical needs - Alzheimer's
disease, Huntington's disease and hormone-refractory prostate cancer,
the last two of which are likely Orphan Drug indications. Dimebon(TM),
with a 20-year record of human use, has generated positive results in
a randomized, double-blinded, placebo-controlled Phase 2 study in
Alzheimer's disease patients, as well as in animal studies of both
Alzheimer's disease and Huntington's disease. Medivation expects to
initiate a Phase 1-2a study of Dimebon in Huntington's disease
patients in 2006. The MDV300 series compounds are in development for
the treatment of hormone-refractory prostate cancer, and are expected
to enter clinical studies in the first half of 2007. Further
information about Medivation can be found on its website
(www.medivation.com).
Safe Harbor Statement
This press release contains forward-looking statements, including
statements regarding the anticipated timing of regulatory and clinical
milestones on the Company's Alzheimer's disease, Huntington's disease
and hormone-refractory prostate cancer programs, 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. We also caution you that the successful
development of Dimebon for any indication, including Alzheimer's
disease, will require significant additional preclinical and clinical
studies, and we cannot assure you that the results in our prior
studies will be indicative of future results. We also cannot assure
you that we will be able to prove that Dimebon is a safe and effective
treatment for any indication, including Alzheimer's disease, or that
the FDA or any foreign regulatory body will ever grant marketing
approval for Dimebon. Our filings with the Securities and Exchange
Commission, including our Annual Report on Form 10-KSB for the year
ended December 31, 2005, and our Quarterly Reports on Form 10-QSB for
the quarters ended March 31, 2006 and June 30, 2006, include more
information about factors that could affect our financial and
operating results, including factors that could impede or preclude us,
or any of our potential future corporate partners, from receiving
approval to market Dimebon for any indication, including Alzheimer's
disease.
(1)Birks, J. Cholinesterase inhibitors for Alzheimer's disease.
Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.:
CD005593.