Date: 2013-02-20
Type of information:
Compound: IB1001 and certain other assets including two product candidates in pre-clinical development, IB1007 (a recombinant FVIIa) and IB1008 (a recombinant FVIII).
Company: Cangene (Canada) Ipsen (France) Inspiration Biopharmaceuticals (USA)
Therapeutic area: Genetic diseases - Hematological diseases
Type agreement: asset purchase
acquisition
Action mechanism: IB1001 is an intravenous recombinant Factor IX (rFIX) being developed for the treatment and prevention of bleeding episodes in people with hemophilia B.
Disease: hemophilia B
Details: * On February 20, 2013, Ipsen, Inspiration Biopharmaceuticals and Cangene have announced the closing of the sale of IB1001 (recombinant FIX) and certain other assets from Ipsen and Inspiration Biopharmaceuticals, Inc. in connection with Inspiration's bankruptcy proceedings. These assetsinclude two product candidates in pre-clinical development, IB1007 (a recombinant FVIIa) and IB1008 (a recombinant FVIII).
IB1001 is under regulatory review by both the FDA and the EMA. The FDA recently issued a Complete Response Letter (CRL) in connection with the Biologics License Application (BLA) for IB1001 and a clear path to approval has been defined which includes providing additional manufacturing and development information. No additional clinical data was requested under the CRL. Prior to the acquisition by Cangene, Inspiration implemented manufacturing process changes for drug substance to significantly reduce the levels of HCP aimed at eliminating HCP responsible for the immunogenic response to HCP in some clinical trial subjects. Preliminary comparability data available to date on drug substance manufactured using the original and the modified processes suggest that the process changes have been successful with no observed deleterious effect on the factor IX protein itself. Review of the MAA by the EMA is continuing through the regulatory review process. Cangene will immediately assume responsibility for the development of IB1001 and the regulatory activities required to meet these regulatory requirements.
* On February 6, 2013, Cangene has entered into an agreement to acquire investigational hemophilia compound IB1001 and certain other assets from Ipsen and Inspiration Biopharmaceuticals in connection with Inspiration's bankruptcy proceedings. The transaction is expected to close on or about February 15, 2013 and is subject to bankruptcy court approval and customary closing conditions. The IB1001 development program includes a comprehensive set of pharmacokinetic, safety, and efficacy data from a Phase 3 clinical trial in people affected by hemophilia B, including a surgery sub-study.
A biologics license application (BLA) and a Marketing Authorization Application (MAA) for IB1001 are under review by the FDA and the European Medicines Agency (EMA), respectively.Oppenheimer & Co. acted as exclusive financial advisor, and Reed Smith acted as legal advisor, to Cangene on the transaction.
This transaction follows the Asset Purchase Agreement (APA) that Ipsen and Inspiration Biopharmaceuticals have concluded in January with Baxter who acquired the worldwide rights to OBI-1, a recombinant porcine factor VIII (rpFVIII) in development for congenital hemophilia A with inhibitors and acquired hemophilia A, and Ipsen’s industrial facility in Milford (Boston, MA).
Financial terms: Under the terms of the agreement, Cangene will pay approximately $5.9 million upfront for IB1001 and other acquired assets, as well as tiered royalties on net sales and additional payments if certain sales milestones are achieved.
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