Stallergenes SA, world leader in sublingual immunotherapy, and Greer Laboratories, Inc., a leader in allergy immunotherapy in the United States, has signed an exclusive agreement for the United States commercialization rights to Oralair, an investigational grass allergy immunotherapy tablet currently under review by the FDA.

Under the terms of the agreement, Greer will lead the sales and marketing efforts for Oralair in the United States and Stallergenes will be responsible for tablet production and supply. Stallergenes will receive  regulatory and commercial milestone payments totalling up to $120 million (USD), plus royalties and a transfer price.

“We believe that this partnership is an important first step, and if approved Oralair will help to fill an unmet need for grass allergy sufferers who are candidates for allergy immunotherapy,” said John G Roby, Greer president and CEO. “Currently there are no FDA approved oral allergy immunotherapy treatments. Greer is committed to advancing allergy immunotherapy and we see this as a natural extension of our current R&D program for oral immunotherapy. We look forward to working with Stallergenes to help bring this innovative product to both allergy specialists and patients here in the United States.”

Roberto Gradnik, chief executive officer of Stallergenes said, “We are delighted to team with Greer, a leader in allergy  immunotherapy in the United States. Greer has in-depth knowledge of the United States allergy immunotherapy market and strong relationships with allergy specialists. This is the perfect combination, two complementary dedicated allergy immunotherapy companies working together to provide an innovative therapeutic solution for United States grass allergy sufferers.”

Oralair is a grass pollen sublingual immunotherapy tablet that includes five grasses (sweet vernal grass, orchard grass, perennial rye grass, timothy grass, and Kentucky bluegrass) and is being investigated for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in adults and children aged five and older. Grass allergies are the most common seasonal allergy in the United States and most people are allergic to more than one type of grass. The 5 grasses included in Oralair provide a wide range of grass allergy coverage in the United States. If approved, Oralair would be a tablet that dissolves under the tongue and  could be selfadministered at home after receiving the first dose in a physician’s office.

The application pending at FDA is based on results from an extensive clinical development programme. Oralair has been studied in double-blind, placebo-controlled trials, in both Europe and the United States in over 1,500 adults and children. Positive results were achieved in these trials designed to demonstrate that pre-seasonal and co-seasonal treatment with grass allergy immunotherapy reduces patients’ allergy symptoms and their need for symptom-relieving medication and provides a sustained long-term effect after completion of treatment. Oralair was generally well tolerated and the most common treatment-emergent adverse events (greater than 10 per cent) were application site reactions including oral pruritus and throat irritation.

Stallergenes is dedicated to the treatment of allergy-related respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma, using allergy immunotherapy.