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Insmed Incorporated Message Board

  • fudfighter4 fudfighter4 Aug 4, 2013 7:51 AM Flag

    iPlex manufacture as seen by us paid bashers

    Whereas IGF-1 and IGFBP-3 are manufactured in small quantities for research, as far as I am aware only Merck has the technology both for folding the two proteins into the protein complex and for filtering out the flawed variants to produce on a commercial scale a 99%-pure product.

    A reminder of last year's grant of two Orphan designations 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.

    Here's an extract from the guide to completing the application for Orphan designation. The last part of (b) (2) indicates that in order to be granted Orphan designation the Sponsor must demonstrate there is an adequate supply of the drug.

    "(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 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."

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    • ...99%-pure product
      Wasn't Insmed granted a patent to for production methods that achieve 99% purity after the Transave deal?

      • 1 Reply to sigma_capitals
      • Absolutely.

        For newbies - until 2018 Ipsen will own the rights (via a patent licensed from Genentech) to the manufacture in the US of IGF-1 via e.coli host cells.

        However, IGF-1 produced in the body circulates in the bloodstream attached to a binding protein (primarily IGFBP-3) which renders it inactive until needed. Uncomplexed IGF-1 therapy has serious side effects.

        Until 2025, Insmed will own the rights to the manufacture of the high-purity IGF-1/IGFBP-3 protein complex (irrespective of the host cells used) -

        US Patent 7968679 - Purified rhIGF-I/rhIGFBP-3 complexes and their method of manufacture

        "IGF-I, IGFBP-3, and IGF-I/IGFBP-3 complexes typically are purified after expression in recombinant systems using such techniques as size exclusion chromatography, hydrophobic interaction chromatography, and ion exchange chromatography. However, such techniques fail to remove all impurities. For example, IGF-I/IGFBP-3 complexes typically are present in partially purified preparations containing protein aggregates. Moreover, new impurities, such as mass and charge variants of IGFBP-3, have been discovered that are not removed by prior art techniques."

        Claims:

        1. An isolated protein complex comprising insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3), wherein said protein complex is at least 96% free of mass and charge variants as measured by analytical CM-HPLC.

        2. The protein complex of claim 1, wherein said protein complex is at least 97% free ...

        3. The protein complex of claim 1, wherein said protein complex is at least 98% free ...

        4. The protein complex of claim 1, wherein said protein complex is at least 99% free ...

        The multi-id loser spamming the board doesn't tell you the whole story. Although no longer developing the protein complex, Insmed will still be able to earn licensing revenue from commercialisation by others (excluding the CPB rights sold to Shire).

        CPB = Complications of Premature Birth

 
INSM
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