Ipsen is building out its hemophilia franchise by paying $85 million for a 20 percent stake in Inspiration Biopharmaceuticals, along with an option to acquire up to 47 percent of the Laguna Niguel, Ca., company for an additional $174 million, which will be tied to development milestones. The deal structure mirrors that which the mid-sized French group signed with Tercica in 2006, centered on building a global endocrinology business.
Inspiration will take over the development of the French pharma's recombinant porcine factor VIII compound OBI-1, which is set to enter Phase III studies this year. Inspiration also will head global commercial efforts for OBI-1 and its three other hemophilia products in development.
As part of the deal, announced Jan. 21, Ipsen will receive $50 million in convertible notes and a 27.5 percent share of future sales of OBI-1 as part of the deal. At that point, Ipsen also has an option to buy Inspiration.
Ipsen's earlier, and very similar, agreement with Tercica enabled the French group to acquire a smaller equity stake in Tercica, along with an option to increase its share up to 40 percent. In addition to a U.S foothold, Ipsen gained a U.S. and Canadian distribution partner for Somatuline Autogel ('Tercica Gives Ipsen US Foothold,' IN VIVO, Sept. 2006).
"The deal structure allows Inspiration share holders to continue to benefit from a very substantial enterprise value increase they will see over the initial launch of the first products, while providing a clear pathway for Ipsen in the longer term to achieve the goal of controlling the company," said Stephen Evans-Freke, a co-founder and managing general partner at Celtic Pharma, which has a significant equity interest in Inspiration.
In addition to endocrinology, Ipsen also has built up an oncology and neurology franchise, which makes hemophilia its fourth specialized business.
Finding Inspiration In A Diverse Portfolio
When Ipsen licensed full rights to OBI-1 from Octagen in June 2008, after 10 years of collaborating on its development, the French drug maker hoped it could "earn more value from its direct commercialization," according to a statement issued at that time. OBI-1 is being developed for the treatment of patients with acquired hemophilia and hemophilia A who do not respond to human forms of factor VIII.
Now, though, Ipsen's strategy has shifted.
"We're more and more cognizant of what the hematology market is made of ... as we progress our development and get more concrete about future launches, we realize how important it is to provide a portfolio of solutions," Stephane Thiroloix, Ipsen's executive vice president of corporate development, said in an interview.
He noted that the pharma opted to partner with Inspiration because of its pipeline of hematology products that target several aspects of the condition and the expertise its team brings to the table. Some of Inspiration's execs come from larger pharmas that launched the earlier hematology products, such as Baxter.
Inspiration's factor IX product, IB1001, is being developed for the acute and preventative treatment of bleeding in patients with hemophilia B, and also is expected to enter Phase III studies this year. Inspiration also has two earlier stage compounds in the pipeline to target additional hemophilia factors - a factor VIIa and a factor VIII product.
The targeted filing dates for OBI-1 are 2012 and 2013 for two indications: acquired and congenital hemophilia, respectively, and the company expects to submit an application for IB1001 in 2011. Filings for the earlier stage products are expected in 2014 and 2015, Thiroloix said.
Inspiration CEO Michael Griffith estimates that, globally, there are 400,000 hemophiliacs, 25 percent of who currently receive care. There is a large untreated group because of limited access to therapy and the high cost of care, he said.
"We're hoping to be able to change the dynamics and offer the same quality of therapies [available now], but at hopefully a lower cost," Griffith said. He believes that cost of therapy can be lowered largely because of Inspiration's recombinant protein manufacturing technology, which increases cell-line productivity and decreases manufacturing capacity requirements, in turn lowering overall production costs compared to other technologies being used for marketed treatments now.
"We're coming in about 20 years later and seizing the opportunity to take advantage of what's been learned chemically," he added.
Inspiration To Build Commercial Team From The Ground Up
In gaining Ipsen's OBI-1 compound, Inspiration also has a significant amount of work ahead since it now has to establish a commercial team and sales force in anticipation of product approvals. Marketing the drugs will be Inspiration's responsibility.
"One of our big tasks now is building a commercial team," Griffith said.
Inspiration expects to have about 70 sales reps globally, though this number is not set in stone, yet. The deal is expected to close in the first quarter of 2010.
-Carlene Olsen (c.olsen@elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY –Jan 21, 2010
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