Medivation Elects Dawn Graham to Board of Directors
SAN FRANCISCO, CA -- (Marketwired) -- 04/23/13 -- Medivation, Inc.
(NASDAQ: MDVN) today announced that Dawn Graham has been elected to
the Company's Board of Directors. Ms. Graham joins Medivation
following a 23-year career in pharmaceutical commercial leadership
positions at Merck & Co. Inc., from which she retired in 2011 as
President of Europe and Canada.
"Dawn's depth of knowledge and experience in the pharmaceutical
industry and her significant commercial expertise will make her an
outstanding contributor to our board as we look to maximize the
commercial opportunity for XTANDI and to diversify our portfolio to
include other product candidates," said David Hung, M.D., president
and chief executive officer of Medivation, Inc. "The international
commercialization expertise that Dawn brings to our board will be of
particular benefit to Medivation as our business interests expand
outside the United States."
"With the recent launch of XTANDI, Medivation has established a
strong foundation for global commercial success," said Ms. Graham.
"The speed and efficiency with which XTANDI was advanced from the
laboratory to commercialization is quite impressive, and I look
forward to working with the Medivation team to optimize XTANDI's
commercial opportunity and to seek to replicate its successful track
record with other potential product candidates."
Ms. Graham has more than 30 years of pharmaceutical industry
experience spanning the U.S., Europe, Asia and Canada. In March 2011,
Ms. Graham retired from Merck & Co., Inc, one of the world's leading
healthcare companies, where she worked in the commercial side of the
organization for 23 years. Ms. Graham is the former President of
Europe/Canada for Merck, where she oversaw commercial operations in
approximately 30 EU and EU accession countries. Before moving to
Europe, Ms. Graham was President of Merck in Canada and prior to
that, she was Vice President of Merck for Asia Pacific where she
focused on advancing the commercial interests of Merck in Japan and
Ms. Graham was the Chair of the Board of Rx&D, the Canadian
pharmaceutical industry association, and she has served on a number
of Boards in Canada including the Conference Board of Canada. She
currently serves on the Board of the Centre for Drug Research and
Development, Canada's national, not-for-profit drug development and
commercialization center, and the Health Research Foundation. In
2009, Ms. Graham was elected "one of the most powerful women in
Canada" by the Canadian Women's Executive Network.
Medivation, Inc. is a biopharmaceutical company focused on the rapid
development of novel therapies 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 families. For more information, please visit us at
About XTANDI(R) (enzalutamide) capsules
XTANDI is indicated for the treatment of patients with metastatic
castration-resistant prostate cancer (mCRPC) who have previously
Important Safety Information for XTANDI
can cause fetal harm when administered to a pregnant woman based on
its mechanism of action. XTANDI is not indicated for use in women.
XTANDI is contraindicated in women who are or may become pregnant.
Warnings and Precautions- In the randomized clinical trial, seizure
occurred in 0.9% of patients on XTANDI. No patients on the placebo
arm experienced seizure. Patients experiencing a seizure were
permanently discontinued from therapy. All seizures resolved.
Patients with a history of seizure, taking medications known to
decrease the seizure threshold, or with other risk factors for
seizure were excluded from the clinical trial. Because of the risk of
seizure associated with XTANDI use, patients should be advised of the
risk of engaging in any activity where sudden loss of consciousness
could cause serious harm to themselves or others.
Adverse Reactions- The most common adverse drug reactions (≥
5%) reported in patients receiving XTANDI in the randomized clinical
trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot
flush, peripheral edema, musculoskeletal pain, headache, upper
respiratory infection, muscular weakness, dizziness, insomnia, lower
respiratory infection, spinal cord compression and cauda equina
syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade
1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and
in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin
occurred in 3% of XTANDI patients and 2% on placebo. One percent of
XTANDI patients compared to 0.3% on placebo died from infections or
sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI
patients vs 1.3% on placebo. Falls were not associated with loss of
consciousness or seizure. Fall-related injuries were more severe in
XTANDI patients and included non-pathologic fractures, joint
injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6%
of XTANDI patients and 0.3% on placebo, with the majority on
opioid-containing medications at the time of the event.
Drug Interactions- Effect of Other Drugs on XTANDI: Administration of
strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI.
Co-administration of XTANDI with strong CYP2C8 inhibitors should be
avoided if possible. If co-administration of XTANDI cannot be
avoided, reduce the dose of XTANDI. Co-administration of XTANDI with
strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma
exposure of XTANDI and should be avoided if possible.
Effect of XTANDI on Other Drugs: XTANDI is a strong CYP3A4 inducer
and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4,
CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as
XTANDI may decrease the plasma exposures of these drugs. If XTANDI is
co-administered with warfarin (CYP2C9 substrate), conduct additional
For Full Prescribing Information, please visit www.XtandiHCP.com.
Chief Business & Financial Officer
Sr. Director, Investor Relations
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