SAN FRANCISCO, CA--(Marketwired - Jul 10, 2014) - Medivation, Inc. (
"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® (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 INR monitoring.
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.