SAN FRANCISCO, CA--(Marketwired - Apr 23, 2013) - Medivation, Inc. (
"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 China.
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 www.medivation.com.
About XTANDI® (enzalutamide) capsules
XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.
Important Safety Information for XTANDI
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 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 INR monitoring.
For Full Prescribing Information, please visit www.XtandiHCP.com.