Paladin Labs Inc. has received the Health Canada approval for its Oralair. Oralair is a sublingual grass pollen immunotherapy tablet for the treatment of the symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without conjunctivitis.

“We are pleased and excited that Health Canada has granted regulatory approval for Oralair,” said Mark Beaudet, interim president and chief executive officer of Paladin Labs Inc. “We anticipate launching Oralair in time for the 2013 allergy season and are confident that, when launched, Oralair will provide Canadian allergy sufferers with a safe, effective and convenient alternative for the treatment of seasonal grass allergies.”

The prevalence of grass pollen allergy in Canada is not well established, however, if prevalence is assumed to be similar to European rates, approximately 20 per cent to 25 per cent of adult Canadians have respiratory allergies, and of these about 50 per cent would be allergic to grass pollen. The current standard of care for grass allergy immunotherapy is multiple injections of grass allergens performed in a doctor's office. Oralair is a sublingual tablet which can be taken in the comfort of one's own home and has an unmatched safety profile. Oralair efficacy has been demonstrated through five placebo controlled clinical trials involving more than 1,000 patients from Europe and North America.

“We are delighted that Oralair has received regulatory approval in Canada. This approval confirms the strength of our clinical data and is a good base to continue together with our partner Paladin Labs the success already achieved by the product in other markets. It also demonstrates Stallergenes' strategy to strengthen its international expansion,” said Roberto Gradnik, CEO of Stallergenes SA.

Oralair has been marketed in Europe since 2008 and is now approved in 27 countries. Paladin obtained the Canadian development, promotion and distribution rights for Oralair (grass allergies), hdm tablet (dust mites allergies) and Stalair rBet v 1 tablet (birch pollen allergies) from Stallergenes SA (Euronext Paris CAC small) in January 2007.

Oralair is a sublingual immunotherapy tablet consisting of five pollen extracts corresponding to the epidemiological characteristics of patient exposure: rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum).

Oralair is indicated for the treatment of the symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without conjunctivitis in patients 5 to 50 years of age, confirmed by clinically relevant symptoms, a positive cutaneous test and a positive titre of the specific IgE to Poaceae grass pollen, who have suffered from allergic rhinitis with or without conjunctivitis for at least two pollen seasons and have not adequately responded to, or tolerated, conventional pharmacotherapy.

Oralair is administered once daily pre-seasonally (4 months prior pollen season) and co-seasonally (during pollen season). Although the grass pollen season varies geographically, typically patients will begin their therapy in January and continue until July.

A pharmacodynamic study has demonstrated that Oralair is effective from the first month of treatment. In addition, the sustained efficacy of Oralair following treatment in 3 consecutive allergy seasons continues to be studied as part of a long term follow up study involving patients initially enrolled in the product's pivotal trial.

Treatment with Oralair should only be prescribed and initiated by physicians with adequate training and experience in the treatment of respiratory allergic diseases.

Paladin Labs Inc., is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products.