MONTREAL, CANADA--(Marketwire -03/21/12)- Paladin Labs Inc. (TSX: PLB.TO - News) announced today that Health Canada has approved 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% to 25% of adult Canadians have respiratory allergies, and of these about 50% would be allergic to grass pollen(1). 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, Chief Executive Officer 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™ Dosing Regimen
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.
Who Should Prescribe Oralair™?
Treatment with Oralair™ should only be prescribed and initiated by physicians with adequate training and experience in the treatment of respiratory allergic diseases.
About Paladin Labs
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at www.paladinlabs.com
(1) Bauchau V, Durham SR. Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J 2004;24:758-64
This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company's Annual Information Form for the year ended December 31, 2010. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.
Samira Sakhia, CA, MBA
Paladin Labs Inc.
Chief Financial Officer