BioWorld International Correspondent

PARIS - Stallergènes SA plans to launch a hay fever remedy in tablet form in 2007, heralding a major shift away from the mode of administration of most allergy treatments today, which is by subcutaneous injection.

It also is developing a tablet for mite allergy.

At the same time, Stallergènes is developing second-generation treatments based on recombinant allergens and has completed an initial Phase I/II trial of its first recombinant treatment (for allergy to birch pollen). The trial involved administration by subcutaneous injection, but a future Phase III trial would use a tablet formulation, Stallergènes' CEO, Albert Saporta, told BioWorld International.

Stallergènes, which is based in the Paris suburb of Antony, was founded by the Institut Mérieux in 1962. Mérieux sold the company to the Paris-based investment bank Wendel Investissement in 1994, and four years later Stallergènes went public, securing a listing on the Second Marché of the Paris stock exchange. Wendel sold 52 percent of its holding in the company, leaving it with 48 percent.

Stallergènes is a world leader in allergen immunotherapy, which entails desensitizing sufferers to the source of their allergy. Stallergènes maintains that desensitization is the only "truly curative" means of dealing with allergy. The allergen extracts injected subcutaneously are loaded onto physiological adjuvants, either calcium phosphate or aluminum hydroxide. The extracts include a range of hymenoptera venoms, in particular for protection against wasp and bee stings. The other main allergies targeted by Stallergènes are rhinitis and asthma.

The tablets it now is developing will enable it to market allergy treatments through pharmacies. At present, it supplies custom-made treatments direct to individual patients, who must have obtained a doctor's prescription, ideally from an allergy specialist, Saporta said. Patients have to return to their doctor each time they need an injection of the treatment. The company handles 3,000 prescriptions a day, 70 percent of which come from outside France.

Saporta said the tablets will not be tailor-made to target the specific allergens to which the individual patient is most sensitive. They will deliver a set of the most common allergens that should meet the needs of three-fourths of patients, while those with rarer conditions might have to continue purchasing specific treatments tailored to their requirements.

A final Phase IIb/III trial of Stallergènes' hay fever tablet has been completed and the results are expected in December. It involved 600 patients at 50 centers in 10 countries. The company would file the product with the regulatory authorities in Europe next year and have it on the market in 2007, if all goes well.

A Phase I/II trial for mites has been completed and final results are pending. A Phase III trial will be initiated once the results of the hay fever trial are in.

The next step in Stallergènes' development will be the switch to recombinant allergens. Saporta said the company had been working on that for years, but recent advances in genetic engineering had enabled it to produce its first recombinant allergen. Recombination yielded a purer product that was easier to characterize, he said.

The company is comparing several expression systems (including bacteria, yeast and tobacco leaves) for the efficient production of recombinant allergens presenting the same biological properties as natural molecules. Once it has perfected its production process for recombinant allergens, Stallergènes plans to phase out the production of biological allergen extracts, which require more complex procedures.

The first recombinant allergen it developed is BET V1, the principal allergen in birch pollen, for which it purchased a license from Vienna, Austria-based Biomay AG. It has completed a proof-of-concept Phase I/II trial of the product to test its efficacy and tolerability, and the final results will be available in a few months. A tablet formulation will be available by the time the company is ready to initiate a Phase III trial.

Stallergènes also produces a broad range of diagnostic products, including in vivo prick tests and in vitro tests. The company's revenues are set to top €100 million (US$123.4M) in 2005, having already reached EUR95 million last year, when Stallergènes earned a net profit of €9.8 million. Stallergènes has subsidiaries in Germany, Spain, Italy, Portugal and Belgium, as well as distributors in Eastern Europe, North Africa and elsewhere, and currently employs some 500 people worldwide.

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