Onyx Pharmaceuticals and Idis Form Partnership to Introduce Carfilzomib Managed Access Program in Europe
August 08 2013 - 3:36PM
Marketwired
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
onyx@idispharma.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."
About Carfilzomib 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.
About Idis 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.
Forward-Looking Statements 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.
Contacts: Investors Amy Figueroa Senior Director,
Investor Relations (650) 266-2398 Media Lori Melancon Senior
Director, Corporate Communications (650) 266-2394
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