Both companies’ lead recombinant products are scheduled to move into Phase III this year.

Ipsen is to provide Inspiration Biopharmaceuticals with up to $259 million in funding as part of the companies’ strategic partnership to develop Inspiration’s hemophilia products. The deal will also see Ipsen pay $85 million up front for a 20% stake in Inspiration.

Additionally, Ipsen will grant Inspiration an exclusive, worldwide sublicense to the recombinant porcine factor VIII product OBI-1, in exchange for $50 million in convertible notes and a 27.5% royalty on future OBI-1 sales.

The successful development of OBI-1 and Inspirations lead candidate could earn Inspiration another $174 million in clinical and regulatory milestones. For each milestone payment, Ipsen would receive a note convertible into Inspiration equity. The company states that assuming all milestones payments are made and the notes are converted into Inspiration equity, it could feasibly take on a 47% ownership of Inspiration’s equity on a fully diluted basis. Upon certain triggering events, Ipsen would also have the ability to acquire full control of Inspiration.

Ipsen’s OBI-1 is in development for the treatment of patients with acquired hemophilia and hemophilia A who have developed an inhibitory immune reaction to human forms of factor VIII. Inspiration’s lead in-house hemophila product is a recombinant factor IX called IB1001 (rFIX) for hemophilia B. Both OBI-1 and IB1001 are expected to start Phase III trials this year.

Inspiration also has earlier-stage candidates focused on both intravenous and noninvasive dosage forms of factor IX (hemophilia B), factor VIII (hemophilia A), and factor VIIa (hemophilia A&B). It is using its recombinant protein-manufacturing technologies to develop new, more efficacious, and cost-effective hemophila products. The company’s portfolio

As a result of the alliance, global private equity firm Celtic Pharma, has converted both its direct interest in Inspiration’s IB1001 product and its equity interest in the company into a new class of preferred shares in Inspiration. Celtic says that this will give it a significant interest in the new enterprise.

“OBI-1 makes sense to us as a strategic fit in our portfolio of products,” comments John Taylor, co-founder and chairman of Inspiration. “Not only does it add a valuable late-stage product to our pipeline, but it will benefit from our existing development infrastructure and future specialty sales force.”

Jean-Luc Bélingard, chairman and CEO of Ipsen, adds, “Inspiration has both strong development experience and a broad pipeline that will provide the opportunity for new growth on our way to building a new, multiproduct global franchise for Ipsen in hematology. Subject to the products in development being approved by the relevant regulatory authorities and upon successful commercialization, we believe Inspiration’s portfolio including OBI-1 could exceed sales of $1 billion in the next 10 years.”

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