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AFFY > SEC Filings for AFFY > Form 8-K on 13-Jun-2014All Recent SEC Filings

Show all filings for AFFYMAX INC

Form 8-K for AFFYMAX INC


13-Jun-2014

Termination of a Material Definitive Agreement, Financial Statements and Exhibits


Item 2.02 Termination of a Material Definitive Agreement.

On June 10, 2014, Affymax, Inc. ("Affymax") received from Takeda Pharmaceutical Company Limited ("Takeda," and together with Affymax, the "Parties" ) a written notice of termination (the "Notice") of the Collaboration and License Agreement between the Parties, dated June 27, 2006, as amended (the "Agreement"). The Notice provides that, in accordance with the Agreement, the Agreement will be terminated effective as of September 10, 2014. Takeda's decision to terminate the Agreement is a result of its detailed investigation of safety concerns of OMONTYS, which confirmed no quality or manufacturing issues were present, but did not identify a specific root cause for the reactions that were observed in patients treated with the product. In February 2013, in consultation with the U.S. Food and Drug Administration (the "FDA"), Affymax and Takeda voluntarily recalled OMONTYS from the market as a result of post-marketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.

Based on these findings and related discussions with Takeda, Affymax has determined not to exercise its rights with respect to the OMONTYS New Drug Application (the "NDA") and Takeda will work with the FDA to withdraw the NDA.

The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.



Item 9.01. Financial Statement and Exhibits.

(d) Exhibits:

Exhibit No.                               Description
99.1          Affymax and Takeda Announce Termination of OMONTYSŪ (peginesatide)
              Product Collaboration and License Agreement

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