NORTHBROOK, Ill., June 5, 2013 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the company has entered into a distribution agreement with Tecnofarma International Ltd. to distribute enzalutamide (XTANDI® in the U.S.) in Latin America, excluding Brazil, upon regulatory approvals in the various countries. Financial terms of the agreements were not disclosed.
"We are pleased to initiate a distribution arrangement for enzalutamide with Tecnofarma, which represents an important milestone to further expand our oncology business in Latin America," said Martin Mercer , Vice President of Latin America. "Tecnofarma, with whom Astellas already has a relationship through our Mycamine® distribution agreement in Latin America, has a strong Latin American sales and marketing oncology organization, which is why they are an ideal partner to help build the Astellas oncology pipeline with enzalutamide."
Jorge Ramos , CEO Latin America for Tecnofarma: "We want to thank Astellas for trusting us with the distribution rights of this important product. It is an extremely valuable new option for patients in this region."
Enzalutamide (XTANDI® in the U.S.) is an oral, once-daily androgen receptor inhibitor. XTANDI was approved by the U.S. Food and Drug Administration on August 31, 2012 for the treatment of metastatic castration resistant prostate cancer for patients who have previously received docetaxel (chemotherapy). On May 30, 2013, Health Canada approved XTANDI (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer in the setting of medical or surgical castration who have received docetaxel therapy. Marketing applications for XTANDI have also been submitted in Japan, Europe, Switzerland, South Korea and Brazil.
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 coadministration 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.
Astellas Pharma US, Inc. ("Astellas"), located in Northbrook, Illinois, is an affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information on Astellas, please visit our website at www.astellas.us.
Tecnofarma, headquartered in Montevideo, Uruguay, is a principal supplier of pharmaceutical products to the Latin American market. Tecnofarma provides leading pharmaceutical products and technologies in a variety of therapeutic categories. Tecnofarma's field sales force of approximately 2000 representatives calls on physicians and other health care professionals throughout the region.
|SOURCE Astellas Pharma US, Inc.|
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