Ipsen prepares for EU resupply of Increlex; enters deal with Mayoly Spindler

French drugmaker Ipsen (Euronext: IPN) says that Lonza has successfully re-manufactured the active ingredient of Increlex(mecasermin [rDNA origin] Injection). The European Medicines Agency has been informed that Ipsen is preparing for the resupply of Increlex, a treatment for severe Primary IGFD, a unique short stature disorder,  in the European Union.

Ipsen revealed early this year that Lonza was facing manufacturing issues with Increlex at its Hopkinton site (Massachusetts, USA; The Pharma Letter April 25). Lonza has been working closely with the Food and Drug Administration to address these issues. The supply interruption occurred in mid-June 2013 in the USA and in the third quarter of 2013 in Europe and the rest of the world.

Consultations with the EU member states’ national competent authorities are now in process to allow immediate resupply. Resupply in the US is still pending. Ipsen continues to actively address the management of the shortage period in the US to reduce its impact on patients and their families.

Christel Bories, deputy chief executive of Ipsen, stated: “We are very pleased that resupply of Increlexto patients in Europe is imminent. We are still working closely with other national competent authorities to solve the outstanding issues in those countries.”

Ipsen and Mayoly Spindler sign cross- promotion agreement

Additionally, Ipsen announced the signing of a cross-promotion agreement with Mayoly Spindler for their primary care activities in France. Through the creation of a co-managed commercial platform, the two companies will leverage their complementary competencies and product portfolios.