Prophylix Pharma Signs Manufacturing Agreement with Emergent BioSolutions
New York, Tromso October 14, 2014. Prophylix Pharma has signed an agreement with Emergent BioSolutions to manufacture a potentially new FNAIT prophylaxis, NAITgam being by Prophylix and its partners in the EU-funded PROFNAIT consortium of ten universities, hospitals and research organizations. FNAIT is a potentially lethal or disabling bleeding disorder which every year affects 10,000 babies in EU and the US.
NAITgam will be produced from human plasma using Emergent's proprietary hyperimmune manufacturing process, which today is used to produce a number of similar FDA-licensed products such as the anti-D drug WinRho®SDF [Rho (D) Immune Globulin Intravenous (Human)].
Dr. Søren Weis Dahl, Chief Business Officer and EU Project Coordinator, Prophylix comments, "Emergent is the perfect manufacturing partner to complement the efforts of the PROFNAIT partners, New York Blood Center, Biotest Pharmaceuticals Corporation and BloodCenter of Wisconsin who all collaborate to identify plasma donors and collect their plasma for use in NAITgam manufacture." In general, NAITgam can only be produced from plasma from women who have had a baby affected by the rare condition FNAIT.
Barry Labinger, Executive Vice President and President Biosciences Division at Emergent, adds, "We are pleased to leverage our hyperimmune manufacturing expertise and platform to produce clinical grade material for Prophylix Pharma's upcoming clinical studies. We look forward to supporting the team at Prophylix in their efforts to address this unmet medical need."
Ten thousand babies in the United States and European Union suffer each year from a potentially crippling or fatal bleeding disorder called Fetal and Neonatal Alloimmune Thrombocytopenia, or FNAIT. There is no medical product available to prevent the condition, which most often occurs when a mother develops antibodies against her baby's platelets, an important blood component that stops bleeding.
About Prophylix Pharma
Prophylix Pharma AS, Norway and its fully owned subsidiary Prophylix Pharma Inc, New York coordinate the PROFNAIT consortium's drug development activities and lead the procurement of specialty source plasma in the US and manufacture of NAITgam. In addition, Prophylix develops a test for routine typing of pregnant women to identify those at risk of causing FNAIT in their baby. Further information about Prophylix Pharma can be found at www.prophylixpharma.com and at www.profnait.eu.