First market authorizations for liquid 10% immunoglobulin

First marketing authorizations in Europe for IQYMUNE®, LFB’s 10% liquid intravenous immunoglobulin.

Les Ulis, 21th September 2015 – LFB SA announces the first two marketing authorizations for its 10% liquid intravenous immunoglobulin (IVIg) in Europe, namely in the United Kingdom and in Denmark. Thirteen more national marketing authorizations in Europe are expected in the coming months. Simultaneously to this ongoing European decentralized procedure, registrations are to take place in 33 countries in rest of the world, for launches staggered between 2016 and 2020.

Since 26th August 2015, LFB’s « new generation » 10% liquid IVIg has been registered in the United Kingdom and in Denmark since 4th September, in the Core SmPC indications. This immunoglobulin has a high-level of purity, relying namely on an innovative manufacturing process developed by LFB for its liquid immunoglobulins.

For rare immune system disorders. LFB’s 10% liquid IVIg IQYMUNE® will allow clinicians to treat rare immunity disorders, mostly hereditary, such as Primary Immunodeficiencies, Immunologic Thrombocytopenic Purpura, Guillain-Barré syndrome and Kawasaki disease, and acquired conditions such as Secondary Immunodeficiency. These diseases concern dozens of thousands of people in Europe, calling for chronic care most of the time.

Immunoglobulins being more and more prescribed in rare and severe dysimmunitary neuropathic affections, LFB conducts two Phase III clinical trials in Europe in order to register IQYMUNE® in the indications of MMN and CIDP[1], two severe dysimmunitary neuropathic diseases.

Registration on the way in 15 European countries. LFB chose a decentralized procedure for European registration, with the German Paul Ehrlich Institute (PEI) as the referent authority for the procedure. Following the United Kingdom and Denmark, registration for IQYMUNE® is expected in the following European countries: Austria, Germany, Belgium, Spain, Finland, Greece, Hungary, Italy, Luxemburg, the Netherlands, the Czech Republic, Slovakia and Sweden.

LFB reinforces its positions in Immunology. « The registrations for IQYMUNE® in Europe and in 33 countries are to contribute to LFB group’s rapidly growing international activity, with LFB currently making a third of its turnover with international business » points out Christian Béchon, CEO of the LFB group. « Given the increasing global demand in immunoglobulins, the launch of our 10% liquid IVIg, to start in 2016, is of strategic importance » adds Mr. Béchon. The registration of IQYMUNE® in many European countries is also a major milestone for LFB’s research and development policy, particularly active in the field of Immunology. « With two current phases III on IQYMUNE®, and the first anti-D monoclonal antibody under clinical trials (phase II b) in the world, for the prevention of hemolytic disease of the newborn, we have major developments to achieve in the coming years » stresses out Guillaume Bologna, General Manager Development for the LFB group.

IQYMUNE® is to represent as much as 9 tons capacity in 2025, thanks to additional manufacturing capacities with upcoming new fractionation plant in France (city of Arras) that is to start around 2020.

[1] MMN: Multifocal Motor Neuropathy; CIDP: Chronic Inflammatory Demyelinating Polyradiculoneuropathy.