Stallergenes SA and CMC Biopharmaceuticals A/S have entered into an agreement for development and supply of recombinant Bet v 1 (rBet v 1) purified bulk.

Bet v 1 is the protein that embodies most of the allergenicity of birch pollen, so called the major allergen of birch pollen.

CMC Biopharmaceuticals will scale up the manufacturing of GMP purified recombinant Bet v 1 and produce batches for phase III clinical trials and commercial supply.

"CMC will allow us to benefit not only from its experienced management and its state-of-the-art fermentation facilities but also from its compliance with EMEA and FDA requirements," said Albert Saporta, chairman and CEO of Stallergenes. "This agreement will speed our Oralair Bet v 1 project towards late stage clinical trials and registration while securing the supply of active ingredients for commercial batches".

"CMC is pleased to establish such a partnership with Stallergenes in this truly innovative field of recombinant allergens; It is also a great opportunity to leverage our cGMP manufacturing capabilities with the short term prospect of an EMEA/FDA registration of a tablet for desensitization," said Mads Laustsen, CEO of CMC Biopharmaceuticals.

According to World Health Organization (WHO) estimates, 20 per cent to 25 per cent of the world population is suffering from respiratory allergic symptoms, rhinitis and/or asthma.

Birch pollen is a major cause of those allergic symptoms, especially in the Northern countries of the Northern hemisphere. For instance, in Germany, up to 16% of the patients are sensitized to birch pollen.

Stallergenes has carried out a Proof Of Concept trial aiming at demonstrating the ability of Bet v 1 to reduce the symptoms in patients allergic to birch pollen. This double blind placebo controlled study conducted in 150 patients in 5 countries was highly significant in efficacy and has also shown a good safety profile in the rBet v 1 group versus placebo, similar to the natural extract group.

Stallergenes is a European biopharmaceutical company dedicated to desensitization therapies for the prevention and treatment of allergy-related respiratory diseases, e.g. rhino-conjunctivitis and allergic asthma.