Inspiration Biopharmaceuticals (Inspiration) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced the closing of the sale of the proprietary hemophilia B product, IB1001 (recombinant FIX), to Cangene Corporation (TSX: CNJ) (Cangene). The transaction was announced on February 6, 2013. Ipsen and Inspiration jointly agreed to sell their respective commercialization rights to IB1001 as part of the transaction. Cangene acquired worldwide rights to IB1001, a recombinant factor IX currently under regulatory review in the United States and Europe. This transaction follows the announcement last month that Inspiration and Ipsen had agreed to sell OBI-1 (recombinant porcine FVIII) to Baxter International.
Cangene acquired worldwide rights to IB1001, as well as Inspiration's rights to two product candidates in pre-clinical development: IB1007 (recombinant FVIIa) and IB1008 (recombinant FVIII). The total aggregate consideration for these rights may exceed $300 million; including the upfront payment of $5.9 million, sales milestones totaling $50 million and annual net sales payments tiered up to a double-digit percentage of global net sales.
IB1001 is currently under regulatory review by both the FDA in the US and the EMA in Europe. The product was placed on clinical hold by the FDA in July 2012. Inspiration has been working to resolve the issues that led to the clinical hold and has discussed its plans to address the clinical hold with relevant regulatory authorities. Inspiration recently received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for IB1001. A Complete Response Letter is issued by the FDA when the Agency determines that an application cannot be approved in its current form.
The letter is consistent with previous discussions with FDA around the presence of host cell proteins (HCP) in IB1001 that was responsible for formation of anti-HCP antibodies in 26% of clinical trial subjects. Inspiration worked diligently to implement manufacturing process changes for drug substance to significantly reduce the levels of HCP aimed at eliminating host cell proteins 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. No additional clinical data was requested under the Clinical Response Letter. Next steps for the development of IB1001 are now determined by Cangene.
Inspiration previously announced the sale of OBI-1 to Baxter International for a total aggregate consideration that may exceed $700 million, including $185 million in upfront and milestone payments. The United States Bankruptcy Court in Boston approved that transaction on January 24, 2013, and the Federal Trade Commission is currently reviewing the transaction under the Hart-Scott-Rodino Act. The total aggregate consideration for Inspiration's assets through these two transactions may exceed $1 billion.