Paladin Labs Inc.

Paladin Labs Inc.

May 24, 2011 08:00 ET

Paladin Labs Files New Drug Submission for Oralair™

MONTREAL, CANADA--(Marketwire - May 24, 2011) - Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, announced today that it has filed a new drug submission for Oralair™ with Health Canada. Oralair™ is a sublingual grass pollen immunotherapy tablet for the treatment of grass pollen rhinitis with or without conjunctivitis for patients uncontrolled with current symptomatic medications.

The current standard of care for grass allergy sufferers - multiple injections of grass allergens performed in a doctor's office - is very cumbersome for the patients. In addition, one of the potential side effects of such injections is anaphylactic shock. This can be compared to Oralair™, which is a sublingual tablet and can be taken in the comfort of one's own home. Oralair™ has an unmatched safety profile with no severe adverse event reported. Unlike subcutaneous immunotherapy treatments, Oralair™ efficacy is documented with seven placebo controlled clinical trials involving more than 2,500 patients.

"In short we are excited for Canadian allergy sufferers to have an efficacious, safer and more convenient treatment option." said Jonathan Ross Goodman, President & CEO of Paladin Labs.

Paladin obtained the Canadian development, promotion and distribution rights for Oralair™, Actair™ (Dust Mites allergies) and Stalair™ rBet v 1 tablet (birch pollen recombinant allergen) from Stallergenes SA in January 2007. Stallergenes (Euronext Paris SBF120) is a European biopharmaceutical company dedicated to allergen immunotherapy for the treatment of allergy-related respiratory diseases, actively involved in the development of a new therapeutic class: sublingual immunotherapy tablets.

About Oralair

Oralair™ is a sublingual allergen immunotherapy tablet aimed at patients suffering from severe allergic rhinoconjunctivitis caused by grass pollens, inadequately controlled using symptomatic treatments. The Oralair™ active substance consists of five purified and calibrated pollen extracts corresponding to the epidemiological characteristics of patient exposure: perennial rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum).It has been marketed in Europe since 2008 and is now approved in 23 countries.

Oralair™ efficacy and safety have been documented with double-blind placebo controlled trials involving more than 2,500 patients in Europe & North America. From the outset, its clinical development has taken into account the benefit to patients: proven efficacy, safety, ease of use, compliance, and cost-containment through a pre- and coseasonal protocol (the treatment is taken for four months prior to the pollen season and then throughout it, for three consecutive seasons) rather than a perennial protocol (when the treatment is taken all year round). A pharmacodynamic study has demonstrated that Oralair™ is effective from the first month of treatment. The long-term efficacy of Oralair™ – after 3 years of treatment – was demonstrated in the VO53.06 long-term phase III clinical trial in European and Canadian centers.

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

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

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