Paladin Labs Announces the Canadian Launch of Oralair(TM)
November 20 2012 - 4:50PM
Marketwired
Paladin Labs Inc. ("Paladin")(TSX:PLB), a leading Canadian
specialty pharmaceutical company, today announced the launch of
Oralair, Canada's first 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 very pleased to announce the launch of Oralair, the
first allergen immunotherapy tablet to be available in Canada,"
said Mark Beaudet, interim President and Chief Executive Officer of
Paladin Labs Inc. "With Oralair, Canadian patients now have a safe,
effective and convenient way to relieve their seasonal grass
allergy symptoms."
Oralair is a sublingual tablet administered once daily and
initiated 4 months before the expected onset of the grass pollen
season and then throughout the season. Oralair has an unmatched
safety profile and its efficacy has been demonstrated through five
placebo controlled clinical trials involving more than 1,000
patients from Europe and North America.
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 has been marketed in Europe since 2008 and is now
approved in 28 countries. Paladin obtained the Canadian
development, promotion and distribution rights for Oralair (grass
allergies), HDM tablet (dust mites allergies) and Stalair(TM) birch
tablet (birch pollen allergies) from Stallergenes SA (Euronext
Paris CAC small) in January 2007.
About Oralair
Oralair is a sublingual immunotherapy tablet consisting of five
grass pollen extracts: rye grass (Lolium perenne), meadow grass
(Poa pratensis), timothy grass (Phleum pratense), cocksfoot
(Dactylis glomerata) and sweet vernal grass (Anthoxanthum
odoratum).
Oralair Indication
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
Forward-looking statements
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, 2011. 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.
Contacts: Samira Sakhia, MBA, CPA, CA Chief Financial Officer
Paladin Labs Inc. Tel. : 514-669-5367 514-344-4675 (FAX) E-mail :
info@paladinlabs.com Website : www.paladinlabs.com