Lonza and LFB today announced the signing of an agreement to manufacture a monoclonal anti-RhD antibody developed by LFB. Under this agreement, the process developed by LFB will be transferred to Lonza which will provide GMP manufacturing services for supporting the phase III clinical program. Lonza, with its successful regulatory track record, will also support LFB in its regulatory submissions by providing appropriate documentation. Financial details of the agreement are not being disclosed.
The monoclonal anti-RhD antibody is used in case of rhesus incompatibility between a mother and her fetus. RhD-negative women who carry a RhD-positive fetus may produce antibodies to fetal RhD antigens. This new compound will ensure guarantee of supply as in this indication only plasma-derived therapies are available. The antibody, which is currently in phase I will enter phase II efficacy trial in the second half of 2009.
“We are very pleased to enter this new collaboration with LFB, a successful French biopharmaceutical company and major player in plasma-derived medicinal products. Supporting LFB in the development of proteins using innovative technologies is exciting and will be the basis for a long-term relationship.”, said Dr. Stephan Kutzer, Head of Lonza Biopharmaceuticals.
“LFB’s monoclonal anti-RhD antibody is now entering a strategic phase of its development. We chose Lonza, a worldwide recognized player, to partner with us on this major project” added Bertrand Mérot, Chief Operations Officer at LFB Biotechnologies.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.
About LFB S.A.
LFB is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, namely Hemostasis, Immunology and Intensive Care. LFB Group is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide and is also among the leading European companies for the development of monoclonal antibodies and new-generation proteins based on biotechnologies. With its strong focus on research, the LFB Group is pursuing a growth strategy that seeks to extend its activities at international level and develop innovative therapies. LFB markets its products in 20 countries and is present in Germany and the UK since 2007 and in Brazil since 2004. Christian Béchon is president and CEO of the LFB Group (1531 employees).
For further information : http://www.lfb.fr
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