Cangene Announces Agreement to Acquire Late Stage Hemophilia B Product
News Feb 07, 2013
Cangene Corporation (Cangene) has announced that it has entered into an agreement to acquire investigational hemophilia compound IB1001 and certain other assets from Ipsen and Inspiration Biopharmaceuticals, Inc. 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.
IB1001 is an intravenous recombinant Factor IX (rFIX) being developed for the treatment and prevention of bleeding episodes in people with hemophilia B.
Hemophilia B is caused by a congenital FIX deficiency, leading to poor coagulation of the blood and potentially life-threatening hemorrhages.
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 U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively.
Based on recent communications with the FDA, a clear path to approval has been defined. Review of the MAA by the EMA is continuing through the regulatory review process.
John A. Sedor, President and Chief Executive Officer of Cangene says "The acquisition of IB1001 is consistent with our strategy of targeting late stage products to drive growth in our commercial business."
Mr. Sedor adds "We are a patient-focused Company and the addition of IB1001 to our pipeline provides an opportunity to address a significant global need for patients with hemophilia B. We will use our significant experience in developing and commercializing biological products to resolve the regulatory challenges and bring value to hemophilia B patients and to Cangene."
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.
"The acquisition of IB1001 represents an opportunity to add a fifth product to our commercial portfolio, and once regulatory approval is received, will further leverage our North American sales team" says Michael Adelman, Vice President, Commercial Operations.
"IB1001 will support our ongoing efforts to enhance value to our customers and will benefit from our experience in the hematology community. Additionally, IB1001 provides a potential revenue stream from international partnerships directed at expanding hemophilia B treatment programs worldwide" adds Mr. Adelman.
Oppenheimer & Co. acted as exclusive financial advisor, and Reed Smith acted as legal advisor, to Cangene on the transaction.