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Insmed Incorporated Message Board

  • fudfighter4 fudfighter4 Nov 6, 2012 1:13 PM Flag

    Finally there is a manufacturer for iPlex once more

    Here are the details of the recent 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.

    To pre-empt any misunderstanding, the Orphan designation was granted in each case on the reported date, but in neither case is the actual use of iPlex in that Orphan indication yet approved by the FDA. Phase III clinical trials have historically been required before the FDA issues the final marketing authorisation.

    Below is 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 that there is an adequate supply of the drug. Both Premacure and PCUT must have supplied the name and address of a manufacturer.

    "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. A sponsor may request orphan drug designation of a previously unapproved drug, or of a new orphan indication for an already marketed drug. In addition, a sponsor of a drug that is otherwise the same drug as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent drug for the same rare disease or condition if it can present a plausible hypothesis that its drug may be clinically superior to the first drug. More than one sponsor may receive orphan drug designation of the same drug for the same rare disease or condition, but each sponsor seeking orphan drug designation must file a complete request for designation as provided 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."

    In my thread - "Merck has not forgotten its relationship with Insmed" - I posed the question -

    "Why the implication that there is an ongoing relationship with Insmed?"

    One wonders if the manufacturer named by Premacure and PCUT might have been Merck, given that when Merck acquired the Boulder facility from Insmed it acquired the only facility in the World at which the protein complex was being manufactured.

    Merck would have learned all about the potential of iPlex in the course of the extensive due diligence which preceded that $130 million deal.

    Apart from the obvious possibility that Genentech and Ipsen might decide to negotiate a deal to put iPlex on sale once more as a growth-promoting therapy before Genentech's IGF-1 patent expired in 2018, development of iPlex as a therapy for the complications of preterm birth had been ongoing for at least two years at the point when Merck acquired the Boulder facility. From a 2007 PR -

    "A Phase I clinical study investigating IPLEX(TM) as a treatment for ROP is underway at the University of Goteborg, in collaboration with scientists at the Harvard Medical School."

    Just as Merck would have formulated comprehensive peak revenue projections for the two biosimilars which were central to the 2009 acquisition of the Boulder facility (neither of which has yet progressed to Phase III) Merck would also have formulated peak revenue projections for iPlex.

    One wonders if Merck ever shut down that unique FDA-approved manufacturing process.

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