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  • druid_of_scranton druid_of_scranton Jul 13, 2013 11:53 PM Flag

    OT AFFY from their 10K biosimilars: (bad news)

    "...The introduction of biosimilars into the rEPO market in the U.S. will constitute additional competition for OMONTYS if we are able to reintroduce the product. A biosimilar product is a subsequent version of an existing, branded biologic product. The patent for the existing, branded product must expire in a given market before biosimilars may enter that market. The patents for epoetin alfa, a version of rEPO, expired in 2004 in the E.U., and the remaining patents expired in 2012 through 2015 in the U.S. Several biosimilar versions of rEPO are available for sale in the E.U. and biosimilar versions of rEPO are currently being studied in clinical trials in the U.S. For example, in January 2012, Hospira, Inc. announced the beginning of its Phase 3 clinical program for its biosimilar with results anticipated in 2013, and in October 2012, Sandoz announced the beginning of its Phase 3 clinical program for its biosimilar with results anticipated in 2014. Upon entry into the U.S. market, biosimilars will compete with OMONTYS, when and if we reintroduce the product, and will drive down its price and sales volume, which would adversely affect our revenues."

    I don't see much hope for AFFY at this point (but who knows)

    As opposed to QCOR with no safety issues.. no patents...

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    • I really got burned on this stock!!!

    • What's your point???

      • 1 Reply to pissy_joe65
      • Affy's only drug loses patent protection net year and year after and also gets a generic competitor.

        That's what.

        There was a time when QCOR was supposedly going to get a "synthetic" and that was the reason the share price fell (not manipulation you see).

        The fact is, no one can introduce one because QCOR is protected, not by patents that expire, but by "trade secrets" which means anyone introducing one has to do their own phase I, II and III trials with all of the safety and efficacy studies.

        I think I mentioned this before, when QCOR was $25 and Michael had his panties all in a wad over some Fly on the Wall report about a synthetic.

        Novartis' Synacthen was never being studied for any indications that competed with QCOR. Novartis wasn't even doing any studies to introduce it into the US market.

        But apparently QCOR management decided that non-threat was enough to suppress the share price by enough to take that threat out anyway.

        Max was thinking AFFY would do like KERX. I think he might want to reconsider his position. I don't see it recovering.

        I don't really know all that much about no earnings dug stocks since I never buy them, as I prefer drug stocks that have real earnings with no patent or competition issues. I just thought I would mention it because others are interested in AFFY.

        You know, for diversification and all.