Navigation Links
Astellas Signs Distribution Agreement With Tecnofarma For Enzalutamide In Latin America
Date:6/5/2013

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."

About Enzalutamide
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.

About Astellas
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.

About Tecnofarma
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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. First sales of DIFICLIRâ„¢ by Astellas Pharma Europe triggers 10 Million Euro Milestone Payment to Optimer Pharmaceuticals
2. Astellas and Fujita Health University Discover Neuronal Maturation Deficits in Patients Suffering from Schizophrenia and Bipolar Disorder
3. Astellas to Close Urogenix, North Carolina-based Urology Research Facility
4. Personal Connections Drive Employee Participation For Changing Tomorrow Day at Astellas
5. Astellas Announces Acceptance of U.S. New Drug Application for Tacrolimus Extended Release Capsules
6. Ambit and Astellas Announce Presentation of Results from Phase 2 ACE Study of Quizartinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) at the 54th Annual Meeting of the American Society of Hematology
7. Astellas Highlights Progress to Advance Care of Patients with Genitourinary Cancers at ASCO-GU Annual Meeting
8. Astellas to Drive PGA TOURs New Womens Initiative
9. PGA TOUR Celebrates Official Launch of the Astellas Presents Executive Womens Day Program
10. Astellas and Ambit to End Collaboration for Joint Development and Commercialization of FLT3 Kinase Inhibitors
11. Astellas Pharma Inc.: New Hire Reinforces Global Compliance Structure
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... MARLBOROUGH, Mass., May 10, 2017 Hologic, Inc. ... financial results for the fiscal second quarter ended April ... (EPS) of $1.84 increased 666.7% compared to the prior ... business resulted in a significant gain, while non-GAAP diluted ... increased 3.2%, or 3.8% in constant currency terms.  Excluding ...
(Date:5/10/2017)... CSSi, the global leader in patient recruitment, ... is proud to announce the launch of its newly ... both enriched content and a customized layout that provides ... already well-established position as the top global patient recruitment ... months of hard work, we are delighted to officially ...
(Date:5/9/2017)... 2017  Semler Scientific, Inc. (OTCQB: SMLR), an ... improve the clinical effectiveness and efficiency of healthcare ... quarter ended March 31, 2017. ... to identify when preventive care options are appropriate, ... heart attacks or strokes occur," said Doug ...
Breaking Medicine Technology:
(Date:5/27/2017)... ... May 27, 2017 , ... Hate visiting the dentist? You should go twice per ... take care of your teeth at home. Here are some dental tips to help out: ... a small toothbrush in your work desk or a locker at school for a quick ...
(Date:5/27/2017)... ... ... Most us are familiar with the sound of occasional popping joints that ... shows that certain people who experience consistent joint popping, grating and grinding are ... opportunity to treat patients before the problem becomes pronounced, potentially hedging off more severe ...
(Date:5/26/2017)... ... May 26, 2017 , ... Leading CEOs from ... May 30th and 31st at The Four Seasons Hotel Boston. , The ... life sciences, offering exclusive access to key decision makers who influence deal making ...
(Date:5/26/2017)... ... May 26, 2017 , ... ... the CareFusion NOX-T3 portable sleep monitor with its Somnoware Sleep Device Interface (SDI). ... interface for diagnostic device operations. With this platform, initializing devices and importing studies ...
(Date:5/26/2017)... ... May 26, 2017 , ... via seating ... mesh back 24/7 task chair specifically designed for clinical areas. Genie Copper Mesh ... to partner with Cupron® to provide customers with a game changing chair that ...
Breaking Medicine News(10 mins):