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Ipsen stake in Inspiration reaches 41 per cent as haemophilia trial starts

Enrolment of first patient into trial of OBI-1 triggers $25m purchase by Ipsen of Inspiration's stock

France-based Ipsen has expanded its stake in US partner Inspiration Biopharmaceuticals following the start of phase III trials of their candidate drug for haemophilia A.

The enrolment of the first patient into the trial of the OBI-1 (recombinant porcine Factor VIII) product triggers a $25m purchase by Ipsen of Inspiration's stock, boosting its stake in the US firm to almost 41 per cent.

The study is the second of two phase III trials scheduled for OBI-1, which is designed to treat patients with congenital haemophilia A who have developed inhibitory antibodies against human Factor VIII replacement therapies. It will gauge the efficacy of OBI-1 in the treatment of severe bleeding episodes.

An earlier phase III study, initiated in November 2010, is looking at the role of OBI-1 in patients with acquired haemophilia A who have developed inhibitors. Preliminary results from this trial were presented in July at the International Society on Thrombosis and Haemostasis (ISTH) annual meeting.

"Currently, patients suffering from haemophilia A who have developed inhibitors have limited therapeutic options," said Marc de Garidel, Ipsen's chairman and chief executive.

Ipsen and Inspiration forged an alliance at the beginning of 2010 which involved the cross-licensing of OBI-1 and Innovation's IB1001, a recombinant factor IX product being developed for the treatment and prevention of bleeding in individuals with haemophilia B.

At the time, Ipsen took a 20 per cent stake in the US firm for $85m, with an option to increase that to 47 per cent, based on milestones achieved in the clinical development programmes for the two drugs. All told, the value of the collaboration could reach $174m.

Last month, Inspiration had its marketing application for IB001 accepted by the European Medicines Agency (EMA), prompting a $35m payment from Ipsen.

In August, the two companies signed a new agreement to create a haemophilia business unit within Ipsen's existing European commercial operations, which will be the exclusive commercial agent for all products marketed under the Inspiration brand in Europe, including IB1001.

29th November 2011


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