Inspiration Biopharmaceuticals, Inc. (Inspiration) announced that the European Medicines Agency (EMA) has validated and accepted the filing of the Marketing Authorization Application (MAA) for Inspiration's IB1001, a recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with haemophilia B. In doing so, the EMA has verified that it will begin its regulatory review process of the MAA.
The application includes safety and efficacy data from Inspiration's clinical program for IB1001, which was conducted in the US, Europe, Israel and India.
Based on Inspiration's partnership agreement with the Ipsen Group, which was signed in January 2010, by receiving the IB1001 MAA submission acceptance for review from the EMA, Inspiration will receive a $35 million milestone payment from Ipsen. In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen's fully diluted equity ownership position in Inspiration to approximately 38 per cent.
In late August, Ipsen and Inspiration extended their partnership to create a haemophilia business unit structure that will act as the exclusive sales organization for all haemophilia products commercialized under the Inspiration brand in Europe.
“The MAA submission for our lead program, IB1001, is Inspiration's first product approval regulatory filing, and a key step in the Company's transformation toward becoming a commercial-stage company," stated John Taylor, co-founder and chairman of Inspiration. “We believe the haemophilia community would like to see greater product choice. Currently, individuals with haemophilia B only have one marketed recombinant FIX treatment option. Our IB1001 programme is designed to increase product supply, provide patient choice, and help achieve our mission to broaden access to care worldwide.”
IB1001, Inspiration's lead product candidate, is an intravenous recombinant FIX product being developed for the treatment and prevention of bleeding in individuals with haemophilia B. IB1001 has completed the pivotal phase III clinical testing for the European regulatory submission, while clinical testing for the US regulatory submission is ongoing. To date, IB1001 has been well-tolerated by patients and pharmacokinetic results have demonstrated non-inferiority to the one approved recombinant FIX product currently available for the treatment of haemophilia B.
Inspiration Biopharmaceuticals is dedicated exclusively to developing treatments for haemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve the treatment of individuals with inhibitor complications.