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Affymax, Inc. (AFFY) Message Board

  • godwinpeak godwinpeak Apr 28, 2013 5:17 PM Flag

    AFFY Longs May Have to Be Patient..... Very Patient

    I have just spent a couple of hours, for fun, researching the Takeda website and the website for the European Medicines Agency (EMA) to see what is going on with Takeda/Affymax and Omontys (peginesatide). Here are some interesting observations.

    At the Takeda website: (1) there is no mention whatsoever of the Affymax milestone/royalties licensing agreement; and (2) the Takeda press release of December 16, 2011 announces Takeda's decision not to commercialize peginesatide in Japan (but to potentially license it to a 3rd party) and to file a Marketing Authorization Application with the EMA during the first quarter of 2012.

    At the EMA website the following is what I discovered: After using the search term "peginesatide", (1) it appears that Takeda has never submitted the Marketing Authorization Application for peginesatide to commercialized for CKD patients on dialysis for the EU; and (2) the only documents pertaining to peginesatide is the EMA decision of October 24, 2012 authorizing Takeda to the modification of an agreed pediatric investigation plan for peginesatide with results to be completed by June 2027, approx. 14 years from now. See EMA decision P/0251/2012.

    From what my efforts have uncovered with respect to Europe and Japan, it does not appear that Takeda has much confidence in peginesatide (Omontys). The longs, however, seem to have great confidence that Takeda is going to somehow rescue Affymax through its vigorous commercialization of Omontys. Wonder how Takeda is doing with the FDA?

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    • The takeda website has Peginesatide listed under core products as holland indicated and says:

      Peginesatide is an erythropoiesis-stimulating agent (ESA) for the treatment of anemia in adult patients on dialysis. It is the first ESA formulation in the U.S. to be approved for once monthly dosing.
      In-house sales regions: U.S.
      Brand Names: OMONTYS (U.S.)
      New Product (Launched in April 2012).

      I'm confident that they take it seriously enough.

    • I am wrong. Takeda apparently did submit the MAA for peginesatide to the EMA in March 2012. There has been no decisions or recommendations made with respect to the MAA submitted March 2012. Takeda's PIP for peginesatide remains with a completion date by June 2027.

      • 1 Reply to godwinpeak
      • Since you like to play the "chicken and egg game" can you find anything in the EMA relating Dendreon Sipuleucel-T becausse I know it was filed and the agency opinion is due mid-june according to J J. DNDN CEO. Perhaps Omontys will be in the may agenda but I know for fact the EMA doesn't publicized their decision. The estimate day is made based upon the filing date.

        Sentiment: Hold

    • Affymax to Receive $5 Million Milestone Payment for Acceptance of European Marketing Authorization Application for Peginesatide
      PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq: AFFY) today announced that it will receive a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide. The milestone is triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for the investigational compound peginesatide for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.

      "We are delighted with Takeda's execution on the European front and are encouraged by the EMA acceptance of the MAA," said John Orwin, president and CEO of Affymax. "While we are concurrently preparing for potential commercialization of peginesatide in the United States, we are pleased that progress is being made to potentially make the product available outside the U.S."

      Peginesatide was discovered by Affymax, and if approved, will be co-marketed by Affymax and Takeda in the United States. Takeda has commercialization rights in the European Union. In the United States, the scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.

      Sentiment: Hold

    • It seems that in your investigation of the takeda website you missed the most important part when looking at their ' core products' list. Core product

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