Manufacturing agreement for recombinant Bet v 1 will help take Stallergene’s Oralair into Phase III trials.

Stallergenes and CMC Biopharmaceuticals inked an agreement for development and supply of recombinant Bet v 1 (rBet v 1) purified bulk. The product is the protein that embodies most of the allergenicity of birch pollen, according to Stallergenes.

Scale up the manufacturing of GMP purified recombinant Bet v 1 will be undertaken by CMC Biopharmaceuticals. The company also will produce batches for Phase III trials and commercial supply.

“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,” remarks Albert Saporta, chairman and CEO of Stallergenes.

Stallergenes reports that it has carried out a proof-of-concept trial aimed 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 five 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, says the firm.

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