In the Press
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In the Press |
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Date: 9th May 2007 Title: STALLERGENES and CMC Biopharmaceuticals sign manufacturing agreement for Recombinant Bet V 1 STALLERGENES SA and CMC Biopharmaceuticals A/S announce today that they have entered into an agreement for development and supply of Bet v 1 purified bulk. The recombinant protein Bet v 1 is the birch major allergen used for ORALAIR® Bet v 1 (Birch), STALLERGENES' sublingual desensitization tablets. The efficacy of desensitization to birch pollen with recombinant Bet v 1 has been demonstrated, through a proof of concept (P.O.C.) study. CMC Biopharmaceuticals will be in charge of scaling up GMP purified recombinant Bet v 1 and producing batches for Phase III clinical trials and commercial supply. "CMC offers a high-performance organization with experienced people and state-of-the-art facilities in full compliance with EMEA and FDA quality standards”, said Albert Saporta, CEO and Chairman of STALLERGENES. “We are convinced that this agreement will enable STALLERGENES to secure the recombinant Bet v 1 development on a long term basis and prepare for the commercialization of ORALAIR® Bet v 1". "CMC is very pleased to have established this partnership with STALLERGENES, the leader in sublingual desensitization. It is a great opportunity for us to leverage our cGMP manufacturing expertise for the benefit of the innovative and challenging recombinant Bet v 1 project," said Mads Laustsen, CEO of CMC Biopharmaceuticals.
The World Health Organisation (WHO) estimates that approximately 20% of the European population suffer from respiratory allergic diseases, of which approximately 14% are allergic to Betulaceae pollen. A subcutaneous Proof of Concept (P.O.C.) study was
carried out in five European countries over two consecutive years,
involving in 150 patients. This study showed highly significant efficacy
and safety results of recombinant Bet v 1 versus placebo. About
STALLERGENES STALLERGENES is listed on the Eurolist Compartment
B of the Euronext Paris Stock Exchange. Additional information is available on www.stallergenes.com. About CMC Biopharmaceuticals
A/S CMC specializes in process and analytical development as well as the scale-up and cGMP manufacture of Active Pharmaceutical Ingredients for pre-clinical, clinical trials and in-market production. CMC’s competitive strength is centered on the flexibility it can offer to customers combined with the extensive experience of its management and key personnel in the field of biopharmaceutical manufacture and development. Additional information is available on www.cmcbio.com
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