Stallergenes and CMC BIOPHARMACEUTICALS sign manufacturing agreement

Signature of an agreement for development and supply of recombinant Bet v 1 (rBet v 1) purified bulk.

Antony, France; Copenhagen, Denmark (May 14, 2007) STALLERGENES SA and CMC Biopharmaceuticals A/S announce today that they 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 stateof-the-art fermentation facilities but also from its compliance with EMEA[1] and FDA[2] 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

[1] EMEA: European Agency for the Evaluation of Medicinal Products
[2] FDA: Food and Drug Administration