Medivation Announces Change in Executive Management Team
SAN FRANCISCO, CA -- (Marketwired) -- 07/10/14 -- Medivation, Inc.
(NASDAQ: MDVN) today announced Dawn Svoronos (formerly Graham) has
been appointed as its chief commercial officer, reporting to David
Hung, M.D., founder, chief executive officer and president of
Medivation. Ms. Svoronos currently is a member of Medivation's Board
of Directors and is a former president of Europe and Canada for Merck
& Co. Inc, where she oversaw commercial operations in approximately
30 EU and EU accession countries. Ms. Svoronos will lead Medivation's
commercial organization on an interim basis and will participate in
the Company's search for a permanent chief commercial officer. Cheryl
Cohen, Medivation's former chief commercial officer, has left the
Company to pursue other opportunities.
"We thank Cheryl for her years of service to Medivation and wish her
the best," said David Hung, M.D., president and chief executive
officer of Medivation, Inc. "We are fortunate to have Dawn Svoronos,
a seasoned executive with significant commercial expertise, step in
on an interim basis to lead Medivation's commercial operations."
Ms. Svoronos, who was elected to Medivation's Board of Directors in
April 2013, has more than 30 years of pharmaceutical industry
experience spanning the U.S., Europe, Asia and Canada. In March 2011,
Ms. Svoronos 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. Svoronos is a former President
of Europe and Canada for Merck. Before moving to Europe, Ms. Svoronos
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, China, and several other
countries in Southeast Asia.
Medivation currently markets XTANDI(R) (enzalutamide) capsules with
its collaboration partner Astellas Pharma, Inc. XTANDI is currently
approved for the treatment of patients with metastatic
castration-resistant prostate cancer (mCRPC) who have previously
received docetaxel chemotherapy. In March 2014, Astellas and
Medivation submitted a supplemental New Drug Application (sNDA) to
the FDA seeking approval of XTANDI for the treatment of men with
metastatic prostate cancer that has progressed on LHRH therapy or
after bilateral orchiectomy. In May 2014, the FDA granted the sNDA
application Priority Review designation with a Prescription Drug User
Fee Act date of September 18, 2014.
Important Safety Information for XTANDI (from the approved
prescribing information) Contraindications: 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 versus 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 for XTANDI (enzalutamide) capsules,
please visit www.XtandiHCP.com.
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 www.medivation.com.
Chief Financial Officer
Sr. Director, Investor Relations
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