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Insmed Incorporated Message Board

  • fudfighter3 fudfighter3 Nov 13, 2013 2:52 PM Flag

    Bo - iPlex as a therapy for MMD ...

    While I do see why you're expecting another MMD study I rather fancy Shire will arrive at that particular destination via a different route.

    As regards demonstrating the potential of iPlex to combat muscle degeneration, MMD offers an unsuitable route. The muscle degeneration in MMD occurs over the life span of the individual, and doesn't result in the drastically shortened life span seen in ALS. So the difference iPlex could make over a year or two is likely to be very small.

    The approval of iPlex as an ALS therapy would suggest efficacy in MMD. But its approval as a therapy for insulin resistance would qualify it as a therapy for both diabetes and MMD.

    Insmed already has lots of Phase II data demonstrating that iPlex improves insulin resistance - including the data from the "failed" MMD Phase II study.

    And for newbies - after a company registers a patent in Europe it must pay an annual renewal fee in each individual European country. When the company ceases to pay the renewal fee the patent lapses in that country.

    Within a couple of years following Insmed's patent infringement setback Insmed had ceased to pay European renewal fees for almost all of its iPlex patents. As far as I am aware Insmed now has only three valid iPlex patents in Europe, two of which cover the manufacturing process. The sole remaining non-manufacturing patent, for which Insmed once again paid renewal fees earlier this year in ten European countries, is this -

    EP1183042 - Methods for treating Diabetes.

    Even more remarkable is that methods of therapy are not patentable in Europe.

    Despite having the two newer manufacturing patents, both of which will be valid for years after the Diabetes patent has expired, Insmed is still paying to maintain the validity of a patent covering the manufacture of iPlex specifically as a therapy for Diabetes.

    I guess the perceived payback is that it covers the treatment of Diabetes by a protein complex of less than 96% purity.

    Important to Insmed?

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    • Last year's grants of Orphan designation for the use of iPlex -

      Generic Name: mecasermin rinfabate
      Trade Name: n/a
      Date Designated: 09-20-2012
      Orphan Designation: Prevention of retinopathy of prematurity in premature infants born at risk for the disease
      Orphan Designation Status: Designated
      FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
      Sponsor: Premacure AB

      Generic Name: mecasermin rinfabate
      Trade Name: Iplex
      Date Designated: 07-23-2012
      Orphan Designation: Treatment of amyotropic lateral sclerosis
      Orphan Designation Status: Designated
      FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
      Sponsor: PCUT BioPartners, Inc.

      From the guide to completing the application for Orphan designation -

      [ Designation of an Orphan Drug § 316.20 Content and format of a request for orphan drug designation.

      (a) A sponsor that submits a request for orphan drug designation of a drug for a specified rare disease or condition shall submit each request in the form and containing the information required in paragraph (b) of this section .....

      (b) A sponsor shall submit two copies of a completed, dated, and signed request for designation that contains the following:

      ... (1) A statement that the sponsor requests orphan drug designation for a rare disease or condition, which shall be identified with specificity.

      ... (2) The name and address of the sponsor; the name of the sponsor's primary contact person and/or resident agent including title, address, and telephone number; the generic and trade name, if any, of the drug or drug product; and the name and address of the source of the drug if it is not manufactured by the sponsor. ]

      Both Premacure and PCUT must have supplied the name and address of a manufacturer.

      Shire's acquisition of Premacure and payment of $11.5 million to Insmed also suggest that iPlex will once again be manufactured. And unlike Insmed, Shire has the financial resources required to develop iPlex for Insulin resistance / Diabetes.

    • What a heartbreaker!
      All that research over the last several years,
      that thoughtful composition (I suppose),
      and pretty much all you get for it is 11 middle fingers over 72 hours.
      Well, at least maybe somebody read it before they gave you the finger.

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