Therapure Biopharma Inc. Signs Multi-Year Manufacturing Agreement With LFB Biomedicaments
Therapure Biopharma Inc. and LFB Biomedicaments, a wholly owned subsidiary of LFB S.A. a French biopharmaceutical company, recently announced the signing of a toll manufacturing agreement under which Therapure will manufacture key plasma proteins to support an expansion by LFB into global plasma derived medicinal markets. Financial terms were not disclosed.
Under the terms of the agreement, Therapure will be responsible for the manufacture of two major plasma proteins and LFB will remain responsible for global regulatory approvals and marketing of these products. Therapure will retrofit its Health Canada licensed manufacturing facility to accommodate the installation of LFB proprietary technology and processes necessary to meets its manufacturing obligations.
The companies expect the facility to be completed in 2011. Qualification and validation process, including regulatory batches will be performed in 2012 in order to complete the regulatory approval process in the course of 2013.
The global market for plasma proteins is expected to grow at a rate of 6% over the next several years. These proteins extracted directly from human plasma include clotting factors that are crucial to patients with congenital or acquired bleeding disorders should be made widely available to these communities. Even though there are sometimes recombinant alternatives to a selection of these proteins, significant investments of time and money are required to bring new sources of supply to market. Therapure will produce these plasma-derived products using LFB’s existing technologies shortening in this manner the time required to bring the increased supply onto the market.
“We are proud to have been chosen by LFB as its contract manufacturer to support this important market expansion” said Thomas Wellner, President and CEO of Therapure. “We will be making a substantial investment in manufacturing capacity to meet LFB’s needs and to provide them with a more globally diversified and secure supply chain for these life-saving products,” continued Mr. Wellner.
"LFB is engaged on rare diseases management and is developing its manufacturing capacities to provide patients with the specific medicines they need" explained Pierre-Francois Falcou, Head of International Operations for LFB. “Their commitment of time and capital to retrofit their Toronto, Canada facility has made us confident that Therapure will be well positioned to significantly contribute to the global expansion of LFB which include North America for added value proteins” concluded Christian Béchon, President and CEO of LFB.
About Therapure Biopharma Inc.
Therapure Biopharma Inc. is an integrated biopharmaceutical company that develops, manufactures, purifies and packages therapeutic proteins. As a contract development and manufacturing organization (CDMO) Therapure Biopharma applies scientific, manufacturing, and downstream purification expertise with an intimate understanding of advanced biology, complex proteins, and regulatory processes to develop effective and innovative solutions to advance products from discovery to market for its clients. Therapure’s Health Canada licensed 130,000 sq.ft. facility, includes manufacturing, research and quality control laboratories and a cGMP warehouse, and is built to U.S. FDA, EMEA, MHRA and Health Canada standards for the aseptic handling and purification of proteins.
For more information, visit www.therapurebio.com
About LFB
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’s 2008 turnover reaches €353 million, of which €67 million were dedicated to the R&D effort.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 more information, visit www.lfb.fr
SOURCE: Therapure Biopharma Inc.