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YM BioSciences, Inc. Ordinary S Message Board

  • drstoks drstoks Dec 28, 2004 9:27 AM Flag

    regarding IMCL's patent & other issues

    like garren, i have lot's of questions on the regulatory hurdles confronting ymi re: egfr. my very superficial take is that there may be a problem that the drug is licensed from cuba, possibly limiting US sales. there is an IMCL patent, possibly limiting european sales. so what is left? these were garren's comment's on ymi's egfr candidate:

    "The technology looks interesting especially the EGFR antibody but I have lots of IP and royalty questions, etc. This is a humanized antibody that is partnered in a joint venture with CIMAB, the commercial arm of CIM (the Cuban Center for Molecular Immunology). The antibody was developed in Cuba. Cuba has spent lots of money and effort developing vaccines and immunologic therapies. In fact Cuba developed the first synthetic antigen vaccine (for meningitis�Neisseria serogroup B). The Cuban programs are very high quality. I do have questions about how they discovered and humanized the antibody in relationship to existing patents in the antibody space. The joint venture may need other licenses to commercialize it in the developed world. There is lots of competition in the EGFR antibody space but they seem to have a relatively direct approach to the market�pivotal trials in combination with radiation for head and neck cancers."

    who can set us straight regarding theracim's path to market?

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    • Thanks dew. So it would be possible for YMI to ink a deal with Imclone, (not that it would happen) with for example a 50/50 split?

      The griffin report numbers are very conservative. For example they put the price of theracim at $15k and market penetration very low for tesmilifiene. I'am not saying they are wrong. I like the fact that they are convservative but if tesmilifene shows a OS in this group of patients any where close to where it was in the first phase 3 trial then they are very low imo.


    • if the cuban antibody works and is blocked by the bush government, then the next government will be run by democrats.

    • Dew posted info on IMCL's patent a few days ago. It would, if enforced, prevent YMI from using their egf'r drug with radiation or chemo. It is being challenged in EU.

      The patent could possibly be worked around using dosing regimes. Chemo/radiation one day. Erbitux the next. I'am not sure how well the patent covers this issue.

      It does not cover erbitux with other egf'r drugs or avastin or other newer biologics.

      Mono use is allowed. Combo patent is being challenged in europe and I'am sure it will be challenged here in the states. They could work out a deal with Imclone.

      The egf'r vaccine drug that was developed in CUBA has already gotten approval to be sold in US if it works. This should make the path for theracim easier.

      YMI owns all rights to tesmilifene.