MILTON, Ontario, April 25, 2016 /PRNewswire/ -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company"), a global specialty pharmaceutical company, today announced the Health Canada approval of BLEXTEN™ (bilastine 20 mg oral tablet) for the treatment of the symptoms of Seasonal Allergic Rhinitis (SAR) and Chronic Spontaneous Urticaria (CSU) (such as itchiness and hives). The approval was granted to Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez formed under the laws of Ireland. BLEXTEN will be distributed in Canada by Tribute Pharmaceuticals Canada Inc., also a subsidiary of the Company.
"BLEXTEN represents an opportunity to introduce the first new antihistamine in Canada in over 15 years," said Adrian Adams, Chief Executive Officer of Aralez. "BLEXTEN represents an additional treatment option that physicians can offer Canadian patients suffering from seasonal allergies and hives. BLEXTEN, is patent protected and qualifies for 8 years of market exclusivity under Health Canada's Office of Patented Medicines and Liaison and we believe all of these factors will play an active role in driving organic growth of the Canadian business."
According to Doctor Gordon Sussman, MD, FRCPC, a Canadian renowned allergy clinical immunology specialist, "A new antihistamine with rapid and effective relief for patients with allergic rhinitis, including both nasal and ocular symptoms, without CNS effects such as somnolence, would be welcome by physicians. When selecting the optimal antihistamine therapy for patients with allergic rhinitis, physicians can look to the revised ARIA 2010 recommendations for further guidance."
BLEXTEN, is an innovative drug, and as such is entitled to an eight-year term of data protection (market exclusivity) under section C.08.004.1 of the Food and Drug Regulations. The Canadian antihistamine market is currently valued at approximately $115 million per year. SAR and CSU are both allergic disorders that can adversely affect quality of life to the extent that work or school productivity may be impaired[i]. The characteristic symptoms of allergic rhinitis are nasal itching, congestion, rhinorrhea and sneezing. 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).
BLEXTEN (bilastine 20 mg oral tablet) is a second generation antihistamine drug for the treatment of SAR and CSU. BLEXTEN exerts its effect as a selective histamine H1 receptor antagonist, and has an effectiveness comparable to cetirizine, fexofenadine and desloratadine. In comparative studies BLEXTEN demonstrated somnolence rates similar to placebo representing a potentially non-sedating effect at therapeutic doses. It was developed in Spain by FAES Farma, S.A. BLEXTEN is approved in Canada and approximately 90 countries including the European Union. Bilastine has not yet been submitted in the United States.
The Company has an exclusive license agreement with Faes Farma, S.A., a Spanish pharmaceutical company, to sell and market BLEXTEN in Canada for the treatment of SAR and CSU.
About Aralez Pharmaceuticals Inc.
Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while focusing on creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez's Global Headquarters is in Ontario, Canada, the U.S. Headquarters is planned to be in Princeton, NJ and the Irish Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.
Cautionary Language Concerning Forward-Looking Statements
This press release includes certain statements that constitute "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, BLEXTEN representing an additional treatment option that physicians can offer Canadian patients suffering from seasonal allergies and hives, the Company's belief that BLEXTEN's patent protection and market exclusivity will play an active role in driving organic growth of the Canadian business and other statements that are not historical facts, and such statements are typically identified by use of terms such as "may," "will," "would," "should," "could," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "likely," "potential," "continue" or the negative or similar words, variations of these words or other comparable words or phrases, although some forward-looking statements are expressed differently.
You should be aware that the forward-looking statements included herein represent management's current judgment and expectations, and are based on current estimates and assumptions made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that it believes are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct and, as a result, the forward-looking statements based on those assumptions could prove to be incorrect. Accordingly, actual results, level of activity, performance or achievements or future events or developments could differ materially from those expressed or implied in the forward-looking statements. Readers are cautioned that actual future operating results and economic performance of the Company, including with respect to the forward-looking statements referred to above, are subject to a number of risks and uncertainties, including, among other things, those described below, and could differ materially from what is currently expected as set out in this press release.
Our operations involve risks and uncertainties, many of which are outside of our control, and any one or any combination of these risks and uncertainties could also affect whether the forward-looking statements ultimately prove to be correct and could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, without limitation, our inability to build, acquire or contract with a sales force of sufficient scale for the commercialization of YOSPRALA™ in a timely and cost-effective manner, our failure to successfully commercialize our product candidates; our failure to successfully launch BLEXTEN and obtain significant market acceptance of this product among physicians, patients, third-party payors and the medical community, costs and delays in the development and/or FDA approval of our product candidates (including YOSPRALA), including as a result of the need to conduct additional studies or due to issues with third-party API or finished product manufacturers, or the failure to obtain such approval of our product candidates for all expected indications, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of its product candidates; the inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca and Horizon for the sales and marketing of VIMOVO, our dependence on Patheon for the manufacture of YOSPRALA™ 81/40 and YOSPRALA™ 325/40; our ability to protect our intellectual property and defend our patents; regulatory obligations and oversight; failure to make, integrate and maintain new acquisitions, such as the integration of Tribute; fluctuations in the value of certain foreign currencies, including the Canadian dollar, in relation to the U.S. dollar, and other world currencies; changes in government regulations, including tax laws and unanticipated tax liabilities; general adverse economic, market and business conditions; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in the Company's SEC filings and reports and Canadian securities law filings, including in our Annual Report on Form 10-K for the year ended December 31, 2015 which are available on EDGAR at www.sec.gov, on SEDAR at www.sedar.com, and on the Company's website at www.aralez.com, and those described from time to time in our future reports filed with the Securities and Exchange Commission and applicable securities regulatory authorities in Canada. You should not place undue importance on forward-looking statements and should not rely upon this information as of any other date. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
Aralez Pharmaceuticals US Inc.
Investor Relations & Corporate Communications
[i] Carter N J, Bilastine In Allergic Rhinitis and Urticaria. Drugs 2012; 72 (9); 1257‐1269.
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