Ipsen and Inspiration file for EU approval for IB1001

Ipsen has announced that its partner Inspiration Biopharmaceuticals has applied for EU approval for IB1001, a new therapy for haemophilia B.

A marketing authorisation application has been filed and accepted that will see the European Medicines Agency evaluating the compound as a therapy for the treatment and prevention of bleeding in individuals with the condition.

The application is supported by safety and efficacy data from clinical studies conducted by Inspiration, which involved patients from Europe, the US, India and Israel.

Ipsen and Inspiration have been collaboratively developing IB1001 since January 2010, with this latest achievement triggering a $35 million (22.71 million pounds) milestone payment to Inspiration.

Marc de Garidel, chairman and chief executive officer of Ipsen, said: "We believe the haemophilia community will positively receive an alternative to the single recombinant factor IX currently on the market."

This comes after the companies agreed in August to create a joint commercial organisation in Europe centred on haemophilia, which will support the launch of IB1001 and other products.