MISSISSAUGA, Ontario, Dec. 19, 2016 /PRNewswire/ -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) (Aralez or the Company) today announced the commercial launch 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) in Canada. BLEXTEN will be distributed in Canada by Tribute Pharmaceuticals Canada Inc. (Tribute), a subsidiary of the Company.
"We are pleased to announce the commercial launch of BLEXTEN in Canada supported by our Canadian sales force," 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 and will play a role in driving organic growth of the Canadian business."
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 Company estimates that the Canadian antihistamine market is currently valued at approximately C$120 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 impairedi. The characteristic symptoms of allergic rhinitis are nasal itching, congestion, runny nose (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 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. Bilastine is approved in Canada and over 100 countries including Japan and most European countries. Consult the product monograph at http://aralez.com/blexten/ for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical department. Call us at 1-866- 391-4503.
The Company has an exclusive license agreement with Faes Farma, S.A., a Spanish pharmaceutical company (Faes), to sell and market BLEXTEN in Canada for the treatment of SAR and CSU.
About Aralez Pharmaceuticals Inc.
Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ and TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez's Global Headquarters is in Mississauga, Ontario, Canada, its U.S. Headquarters is planned to be in Princeton, NJ and the Ireland Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.
Cautionary Note Regarding 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, statements regarding the Company's commercialization of BLEXTEN in Canada, including support from its Canadian sales force, the benefits and risks of BLEXTEN, BLEXTEN as an additional treatment option that physicians can offer Canadian patients suffering from seasonal allergies and hives, BLEXTEN playing a role in driving organic growth of the Canadian business, BLEXTEN as an innovative drug and entitled to an eight-year term of data protection (market exclusivity), the estimated value of the Canadian antihistamine market, the Company's exclusive license agreement with Faes to sell and market BLEXTEN in Canada for the treatment of SAR and CSU, 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. 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 our products in a timely and cost-effective manner; our failure to successfully commercialize our products and product candidates; competition, including increased generic competition; costs and delays in the development and/or approval of our product candidates, 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 our product candidates; with respect to certain products, dependence on reimbursement from third-party payors and the possibility of a failure to obtain coverage or reduction in the extent of reimbursement; 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 AB and Horizon Pharma USA, Inc. for the sales and marketing of VIMOVO®, our dependence on Patheon Pharmaceuticals Inc. for the manufacture of YOSPRALA™, our dependence on Schering-Plough (Ireland) Company for the supply of ZONTIVITY® and our dependence on AstraZeneca AB for the manufacture and supply of Toprol-XL® and its currently marked authorized generic (AG); our ability to protect our intellectual property and defend our patents; regulatory obligations and oversight; failure to successfully identify, execute, integrate, maintain and realize expected benefits from new acquisitions, such as the acquisitions of Tribute, ZONTIVITY and Toprol-XL and its AG; 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 and regulations regarding the pricing of pharmaceutical products; risks related to our financing; 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 Securities and Exchange Commission (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 and our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2016, 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 SEC 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. Contact:
Nichol L. Ochsner
Executive Director, Investor Relations & Corporate Communications
i Carter N J, Bilastine In Allergic Rhinitis and Urticaria. Drugs 2012; 72 (9); 1257‐1269.
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SOURCE Aralez Pharmaceuticals Inc.