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Affymax, Inc. Message Board

  • jagan1961 jagan1961 Apr 27, 2013 9:52 PM Flag

    Read this filing Taken from SEC site - Affy is in a Cool spot, no sweat, no effort!

    Affymax, Inc. (the “Company”) and Takeda Pharmaceutical Company Limited (“Takeda,” and collectively with Affymax, the “Parties”) entered into the Fourth Amendment (the “Amendment”) to the February 13, 2006 and June 27, 2006 Collaboration and License Agreements to amend and restate the ongoing respective roles and responsibilities and related commitments and financial terms between the Parties, including the termination of the Collaboration and License Agreement dated as of February 13, 2006, under which Affymax has granted Takeda a certain right and license for the development and commercialization in Japan of OMONTYS, as amended by the First Amendment, dated April 1, 2007, the Second Amendment, dated January 1, 2008 and the Third Amendment, dated November 7, 2011, as well as the related manufacturing supply, safety, quality and co-promotion agreements between the parties. The Amendment changes the economics from a profit-sharing arrangement to a milestone and royalty-based compensation structure to Affymax effective as of April 1, 2013, and is part of the Company’s ongoing restructuring efforts resulting from the voluntary recall announced on February 23, 2013 related to OMONTYS® (peginesatide) Injection, the suspension of U.S. marketing and promotional activities, and the ongoing investigation with the U.S. Food and Drug Administration, or FDA.

    The Amendment effectuates a transfer of regulatory responsibilities, including the OMONTYS New Drug Application, or NDA, and all manufacturing, and development responsibilities from the Company to Takeda as soon as practicable but in any event prior to April 30, 2013 with related transition services and support. Takeda has agreed to reimburse the Company for certain personnel costs to assist in the transition and investigation activities for the month of April in order to support the planned transition. Takeda receives a worldwide, exclusive royalty-bearing license under Affymax and joint Takeda-Affymax patents to devel

    Sentiment: Hold

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    • Jagan. The more I look into this, the more I am convinced the corrupt Orwin talked about BK to drive the PPS down so his buddies on wall street could pick up more shares. This might have been the plan all along. Here is the ray of light. People still holding will see a windfall in a year and many years to come. I have never doubted that O will be back. I think there is still more drama that will be played out. They will drive the pps even more to panic some longs into selling. The further it goes down, the more I am buying. I am willing to take the risk. This time next year either I would have written Affy off as a tax loss, or will be celebrating the fact that I did not panic and will reap the benefits for years. If this is how it's being played, I will not be surprised if they push PPS down to under 50 cents to pick up more cheap shares from scared investors. GLTA.

    • As a result of the Amendment, Takeda assumes full responsibility for OMONTYS, including the ongoing recall and investigation of OMONTYS as well as any subsequent decisions as to whether the product may be subject to re-introduction if Takeda is able to complete the investigation and address the safety concerns to the satisfaction of the FDA. If Takeda decides to re-introduce OMONTYS, all of which is highly uncertain, the Company is eligible to receive royalties and (i) potential commercial milestone payments totaling up to $180 million of which $10 million is payable upon the first commercial sale after re-introduction of OMONTYS in the U.S., of which a $10 million and another $10 million relates to U.S. sales-based milestones, and of which $150 million relates to sales-based milestones in amounts as previously disclosed outside of the U.S. but now including Japan as a result of the Amendment and (ii) a potential development milestone payment of $5 million payable either upon regulatory approval in the E.U. or Japan. The royalties are tiered in the range of 13-17% with respect to net sales in the U.S. and in the range of 13-24% depending on the level of net sales by Takeda worldwide ex- U.S.

      The foregoing summary of material terms is qualified in its entirety by reference to the Amendment, which will be attached as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2013, portions of which will be subject to a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

      Sentiment: Hold

0.080.0000(0.00%)Oct 21 2:51 PMEDT