SOUTH SAN FRANCISCO, CA--(Marketwired - August 08, 2013) - Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that it is partnering with Idis Limited to initiate a Managed Access Program for carfilzomib in certain countries in Europe for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Managed Access Programs provide biopharmaceutical companies with a way to allow eligible patients ethical access to medicines for unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available.
For more information about Idis' services and its Managed Access Programs, healthcare professionals may contact Idis via telephone on +44 (0)1932 824 123, fax +44 (0)1932 824 323, or via email at email@example.com.
"Idis is the recognized leader in Managed Access Programs, making them an ideal partner to oversee this important initiative on behalf of Onyx," said Pablo J. Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations, Onyx Pharmaceuticals.
Idis, a UK-based global company, has over 25 years of experience partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs.
"Patients with advanced cancer face unique challenges, among them, gaining timely access to innovative new therapies," said Tony Dutta, Managing Director of Idis. "Through our work with Onyx Pharmaceuticals, we will share our expertise in successfully addressing access challenges and help educate a broad range of stakeholders on navigating the options and obstacles that exist for these patients."
Carfilzomib, marketed in the United States (U.S.) under the brand name Kyprolis® (carfilozmib) for Injection, is approved by the U.S. Food and Drug Administration for treatment of patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.
Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.
Idis has 25 years experience partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs. Since 1987, Idis has coordinated access to thousands of medicines, covering every therapeutic category, impacting the lives of hundreds of thousands of patients in countries around the world.
Idis leverages decades of experience, regulatory insight, and a thorough understanding of local and global requirements to create access to medicines at every stage of a product's lifecycle from pre-approval to market exit, and in times of unexpected production shortages.
The company's European headquarters are located in Weybridge, United Kingdom, and its North American headquarters are located in Princeton, NJ.
For more information about Idis please visit www.idispharma.com.
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of Kyprolis® (carfilzomib) for Injection. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2013, filed with the Securities and Exchange Commission under the heading "Risk Factors" for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
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