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Affymax Announces Self-Imposed Quiet Period as the Company Analyzes Phase 3 Results for Hematide/peginesatide

Update: Omontys (peginesatide) Now FDA Approved - March 27, 2012

PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 22, 2010 - Affymax, Inc. (Nasdaq: AFFY) today announced that it has instituted a quiet period to curtail discussions with the investor community and the media in connection with the analysis of Phase 3 results for the investigational drug, Hematide, in four clinical trials (PEARL 1, PEARL 2, EMERALD 1 and EMERALD 2) which evaluated Hematide for the treatment of anemia in chronic renal failure patients.

As analysis of data from the first of the four trials begins, the company expects that full data gathering and analysis will take a period of weeks before top line results are announced some time in June 2010. The company expects to lift the quiet period following disclosure of Phase 3 results.

About Hematide

Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).

Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for Hematide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized in the European Union and Japan by Takeda.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding the success of the collaboration, timing, design and results of the Company's clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Company's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing and room temperature stability, the cardiovascular event rate in our Phase 3 program, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes 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. The Company undertakes no obligation to update any forward-looking statement in this press release.

 

Contact: Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications

 

 

Posted: April 2010

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