Ipsen (Euronext: IPN, ADR: IPSEY) announced today that its partner Inspiration Biopharmaceuticals, Inc. (Inspiration) has initiated treatment of patients in the first of two phase III pivotal clinical studies of OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, for the treatment of acquired hemophilia A, a rare, though potentially life-threatening bleeding disorder.
Under the terms of their partnership agreement signed in January 2010, Inspiration in-licensed OBI-1 from Ipsen, and is responsible for the clinical development, regulatory process and commercialization of the product.
In the context of this first phase III clinical study initiation, Ipsen has subscribed to a US$50 million newly issued convertible note by Inspiration, bringing its fully diluted share ownership position in Inspiration to about 34.0%.
Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen said: “The initiation of this OBI-1 phase III clinical trial marks a milestone in the treatment of acquired hemophilia. Currently, patients suffering from acquired hemophilia do not have access to a reliable satisfactory therapeutic response.
The advancement of OBI-1 development paves the way towards radical improvement in the therapeutic armamentarium available to the medical practice within the coming years.
Ipsen is proud to have started the development of this compound and is convinced that the partnership with Inspiration may result not only in the optimization of the clinical development of OBI-1’s but also in a promising pipeline in the field of hemophilia.”
Source: Ipsen