Affymax Receives a $50 Million Milestone Payment for U.S. Approval of OMONTYS® (peginesatide) Injection
PALO ALTO, Calif.--(BUSINESS WIRE)--
Affymax, Inc. (Nasdaq: AFFY) today announced that it has received a $50
million development milestone payment from Takeda Pharmaceutical Company
as part of the companies' exclusive global agreement to develop and
commercialize OMONTYS® (peginesatide) Injection. The
milestone was triggered by the U.S. Food and Drug Administration (FDA)
approval of OMONTYS on March 27, 2012.
This is in addition to the $5 million milestone payment the company
received from Takeda that was triggered by the European Medicines Agency
acceptance of the Marketing Authorization Application in February.
About Affymax and Takeda Partnership
In 2006, Affymax, Inc. and Takeda Pharmaceutical Company Limited entered
into an exclusive global agreement to collaborate on the development and
commercialization of OMONTYS. Both companies are working together to
co-commercialize OMONTYS in the U.S., while Takeda holds an exclusive
license to develop and commercialize the product outside the U.S.
Based on the acceptance of a Marketing Authorization Application (MAA)
submitted by Takeda, peginesatide is currently under review by the
European Medicines Agency (EMA) for the treatment of symptomatic anemia
associated with chronic kidney disease in adult patients on dialysis.
Takeda and Affymax are exploring options for the commercialization
rights for peginesatide in the Japanese market, including potentially
licensing to a third party.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company based in Palo Alto,
California. Affymax's mission is to discover, develop and deliver
innovative therapies that improve the lives of patients with kidney
disease and other serious and often life-threatening illnesses.
The company's first marketed product, OMONTYS, was approved by the U.S.
Food and Drug Administration (FDA) in March 2012. For additional
information on Affymax, please visit www.affymax.com.
This release contains forward-looking statements, including
statements regarding the continuation and success of our collaboration
with Takeda, the timing and potential for the EMA approval of the MAA in
Europe and the commercialization of OMONTYS. Affymax's actual results
may differ materially from those indicated in these forward-looking
statements due to risks and uncertainties, including risks relating to
the EMA approval of the MAA, risks relating to regulatory requirements
required by the FDA, the EMA or other regulatory authorities, including
post-marketing studies, trials and Risk Evaluation and Mitigation
Strategy (REMS), industry and competitive environment, financing
requirements and our ability to access capital and other matters that
are described in Affymax's Annual Report on Form 10-K filed with the
Securities and Exchange Commission. Investors are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date of this release. Affymax undertakes no obligation to update
any forward-looking statement in this press release.
Vice President, Corporate Communications
Source: Affymax, Inc.
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