GRASTEK™, an allergy immunotherapy tablet for the treatment of signs and symptoms of grass allergy, is now available in Canada

An estimated 20% to 25% of the Canadian population suffer from allergic rhinitis¹

KIRKLAND, QC, Feb. 3, 2014 /CNW Telbec/ - A new treatment option is now available for Canadian allergic rhinitis sufferers. GRASTEK™ (Standardized Allergenic Extract, Timothy Grass (Phleum pratense) Sublingual Tablet), an immunotherapy treatment to help manage grass allergies, is indicated for reducing the signs and symptoms of moderate to severe seasonal Timothy and related grass pollen induced allergic rhinitis (with or without conjunctivitis) in adults and children five years of age and older confirmed by clinically relevant symptoms for at least two pollen seasons and a positive skin prick test and/or a positive titre to Phleum pratense specific IgE; and who have responded inadequately, or are intolerant to conventional pharmacotherapy.²

"The aim of immunotherapy is to prevent or suppress allergic symptoms, such as allergic rhinitis, through repeated administration of the allergen, leading to long-term tolerance," says Dr. Susan Waserman, an immunologist and allergist at McMaster University in Hamilton. "Allergen-specific immunotherapy is an important disease management strategy for patients whose symptoms are not adequately controlled by allergen avoidance and medication."

A clinically documented efficacious treatment, allergy immunotherapy can reduce the patient's allergic symptoms and the need for traditional, symptom-relieving medication.³

Efficacy demonstrated during the first grass pollen season
For optimal results, the dosing should be initiated at least eight weeks before the grass pollen season and maintained throughout this period. However, treatment can be initiated at any time during the year.⁴

"This immunotherapy can begin at any time during the year, but for symptom improvement during the first grass pollen season, allergy sufferers should start taking treatment at least eight to twelve weeks before the grass pollen season begins," says Dr.  Waserman.

Pediatrics
GRASTEK™ has been approved for children aged 5 and above, with safety data established based on three clinical trials which randomized 881 patients between five and seventeen years of age with grass pollen induced rhinoconjunctivitis.⁵

"Patients with allergic rhinitis can find their quality of life significantly impaired, especially children during summer activities. Immunotherapy tablets that can be taken at home are a more convenient option," concludes Dr. Waserman.

With this new treatment option, Merck Canada affirms its longtime commitment to developing respiratory products that provide physicians with a wide range of treatment options to help their patients suffering from allergies.

About allergies and allergic rhinitis
Caused by the immune system over reacting to a normally harmless substance called an allergen, allergic rhinitis sufferers can experience symptoms such as sneezing, congestion, a runny nose, itchiness in the nose, throat, eyes and ears.⁶

Approximately 20% to 25% of the Canadian population suffers from allergic rhinitis, an inflammatory disease whose prevalence is increasing worldwide.¹ Often starting in childhood and persisting into adult life,⁷ allergic rhinitis can have an impact on the sufferers' social life, school performance, and work productivity.⁸

About Merck
Today's Merck is a global healthcare leader working to help the world be well.  Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca.

Forward Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2012 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

The news release is available at www.cnw.ca.

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¹ Keith, P., Desrosiers, M. et al, 2012. The Burden of Allergic Rhinitis (AR) in Canada: Perspectives of Physicians and Patients, Allergy, Asthma and Clinical Immunology [Online] Available at: www.aacijournal.com/content/8/1/7 [Accessed 2013-12-19].
² GRASTEK Product Monograph, Merck Canada Inc., December 12, 2013. Page 3
³ ALK-Abello Pharmaceuticals, Inc., 2012. Allergy Immunotherapy [Online] Available at: www.alkabello.com/ca/allergy/treatment/immunotherapy/Pages/welcome.aspx [Accessed 2013-12-19].
⁴ GRASTEK Product Monograph, Merck Canada Inc., December 12, 2013. Page 15
⁵ GRASTEK Product Monograph, Merck Canada Inc., December 12, 2013. Page 11
⁶ American Academy of Allergy Asthma & Immunology, 2013. Allergic Reactions: Tips to Remember [Online] Available at:
www.aaaai.org/patients/publicedmat/tips/whatisallergicreaction.stm [Accessed 2013-12-20].
⁷ Allergy/Asthma Information Association, 2008. Allergic Rhinitis [Online] Available at: www.aaia.ca/en/allergic_rhinitis.htm [Accessed 2014-01-10].
⁸ Brozek, J. L., Bousquet, J. et al. Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines: 2010 Revision. Journal of  Allergy & Clinical Immunology Vol. 126(3), pp. 466-476

SOURCE: Merck

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