Antony (France), 1 April 2014 – STALLERGENES S.A. (Euronext Paris), the world leader in sublingual immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has approved ORALAIR®, the first immunotherapy tablet to be available in the U.S. for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis.
Until now, allergen immunotherapy has been administered via a series of subcutaneous injections in the allergy specialist’s office. The approval of ORALAIR provides an additional treatment option for allergy specialists and their patients.
Grass allergy is the most common seasonal allergy in the United States and most people are allergic to more than one type of grass. ORALAIR contains a mix of five grass pollens: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. The five grass pollens contained in ORALAIR represent those to which most patients in the U.S. are exposed.
ORALAIR is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.
ORALAIR is a tablet that dissolves under the tongue. The first dose is taken in the doctor’s office under medical supervision, and subsequent doses are administered once a day by the patient or the patient’s caregiver. ORALAIR treatment should be started four months before the expected onset of each grass pollen season and continued throughout the season. Allergy symptoms are reduced beginning with the first grass pollen season.
”We are very pleased with the U.S. approval of ORALAIR as it will bring a true benefit to US patients suffering from grass pollen-induced allergy”, said Christian Chavy, newly appointed Chief Executive Officer of STALLERGENES. “This approval is a major milestone for Stallergenes. The company not only developed ORALAIR but it also continues to expand the frontiers of allergen immunotherapy. I would like to congratulate my predecessor, Roberto GRADNIK and his teams on this major achievement.”
He added: “We look forward to launching ORALAIR with our partner, GREER®, a leader in the U.S. allergen immunotherapy market with strong and long-standing relationships with allergy specialists. Thanks to ORALAIR, U.S. allergy specialists will now be able to offer a valuable treatment alternative to their patients with grass pollen-induced allergy, including those likely to refuse or prematurely discontinue subcutaneous immunotherapy.”
In October 2013, GREER® and STALLERGENES announced the signing of an exclusive agreement for the U.S. commercialization rights to ORALAIR. 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. The approval of ORALAIR triggers a milestone payment from GREER® to STALLERGENES of $10 million (USD), which amount will be capitalized and recognized as revenue over the life of such agreement. Overall, under such agreement STALLERGENES would receive payments on the occurrence of regulatory and commercial milestone events totalling up to $120 million (USD), plus royalties and a transfer price.
ORALAIR was originally approved in Europe in 2008 and is currently authorized in 31 countries around the world, including most European countries, Canada, Australia, and Russia for the treatment of grass pollen allergy. In Canada, ORALAIR was launched in 2012, making it the first allergy immunotherapy tablet to be registered and marketed in North America. Worldwide post-marketing experience with ORALAIR includes more than 20 million doses given to more than 110,000 patients.
ORALAIR has been approved based on results from an extensive clinical development program. ORALAIR has been studied in double-blind, placebo-controlled trials, in both Europe and the United States in over 2,500 adults and children. The results of these trials demonstrated that pre-seasonal and co-seasonal treatment reduces patients’ allergy symptoms and their need for symptom-relieving medication. In the clinical development program, the most common adverse reactions for ORALAIR (reported in ≥5% of patients) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain.
ABOUT THE U.S. ALLERGEN IMMUNOTHERAPY MARKET
The U.S. market offers substantial potential for the development of sublingual immunotherapy: allergic rhinitis affects 60 million people and the most prevalent allergen is grass pollen. Each year, 12.5 million people consult a physician for symptoms of grass pollen allergy.
Today, fewer than 3 million allergy sufferers (i.e., 5% of the U.S. allergic population), are treated with allergen immunotherapy. The current standard of care for immunotherapy is multiple injections administered in a supervised medical setting. There is a strong need for an innovative sublingual treatment that enables patient self-administration.