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news.Tribute Pharmaceuticals Canada and Faes Farma have announced the signing of an exclusive license agreement that grants Tribute the exclusive right to sell Faes's Bilastine product for the treatment of Allergic Rhinitis and Chronic Idiopathic Urticaria (hives) in Canada, following receipt of regulatory approval from Health Canada for such product.
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The exclusive license is inclusive of prescription and non-prescription rights for Bilastine, as well as adult and paediatric presentations in Canada. Terms of the agreement were not disclosed.
Allergic rhinitis and urticaria are both allergic disorders that can adversely affect quality of life to the extent that work or school productivity may be impairedi. The characteristic symptoms of allergic rhinitis are nasal itching, congestion, rhinorrhoea and sneezingii.
For urticaria, characteristic symptoms include itchy skin lesions with a central swelling (wheals) and painful areas of deeper swelling involving the skin and mucous membranes (angioedema)iii. Both types of allergies are common, with a global prevalence of 10-30% for allergic rhinitis and of >20% for urticariaiv.
Even though the cost of care for individuals with allergic disorders is low, the total global cost is high, predominantly because these disorders are so highly prevalentv. According to the Canadian Allergy, Asthma and Immunology foundation, Allergic Rhinitis affects 20% to 25% of Canadiansvi.
IMS Health reports that the Canadian oral antihistamines market had sales of approximately $120 million in 2013. Upon approval by Health Canada, Bilastine will be the first new oral antihistamine approved in Canada since 2001.
Bilastine will provide Allergists, Immunologists, Dermatologists, Family Medicine and General Practitioners a new treatment option for allergic rhinitis and chronic idiopathic urticaria with a clinically proven safety and efficacy profile.
Tribute president and CEO Rob Harris noted that the company is excited to have the opportunity to launch a globally recognized product like Bilastine in Canada, and to further strengthen its dermatology and primary care portfolio.
"Bilastine has been approved in 48 countries worldwide and we look forward to introducing this new and innovative product to Canadian physicians. Furthermore, the execution of this agreement underscores Tribute’s commitment to expanding its business in Canada with licensed, long-term, patent-protected, revenue generating products like Bilastine, while also acquiring and licensing mature products in Canada. Bilastine is a great opportunity for Tribute because it also provides us with the ability to maximize a longer-term revenue source with an over-the-counter strategy as well," Harris added.