Healthcare Industry News: S.A.
News Release - December 19, 2016
Aralez Announces Commercial Launch Of BLEXTEN(TM) In Canada
MISSIS.A.GA, Ontario, Dec. 19, 2016 -- (Healthcare Sales & Marketing Network) -- Aralez Pharmaceuticals Inc. (ARLZ) (ARZ.TO) (Aralez or the Company) today announced the commercial launch of BLEXTEN™ (Bilastine 20 mg oral tablet) for the treatment of the symptoms of S.A.onal Allergic Rhinitis (SAR) and Chronic Spontaneous Urticaria (CSU) (such as itchinesS.A.d 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.A. additional treatment option that physicians can offer Canadian patients suffering from S.A.onal allergieS.A.d hiveS.A.d will play a role in driving organic growth of the Canadian business."
BLEXTEN iS.A. 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 antihiS.A.ine 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.A.e 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).
About BLEXTEN™
BLEXTEN (Bilastine 20 mg oral tablet) iS.A.second generation antihiS.A.ine drug for the treatment of SAR and CSU. BLEXTEN exerts its effect aS.A.selective hiS.A.ine H1 receptor antagonist, and haS.A. 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 S.A.n by FAES Farma, S.A. Bilastine iS.A.proved 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.A.so available through our medical department. Call uS.A. 1-866- 391-4503.
The Company haS.A. exclusive license agreement with Faes Farma, S.A., a S.A.ish pharmaceutical company (Faes), to sell and market BLEXTEN in Canada for the treatment of SAR and CSU.
About Aralez Pharmaceuticals Inc.
Aralez Pharmaceuticals Inc. (NAS.A.: ARLZ and TSX: ARZ) iS.A.global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while creating S.A.eholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez's Global Headquarters is in MissiS.A.ga, 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 S.A.ements
This press release includes certain S.A.ements that constitute "forward-looking S.A.ements" within the meaning of applicable securities laws. Forward-looking S.A.ements include, but are not limited to, S.A.ements regarding the Company's commercialization of BLEXTEN in Canada, including support from its Canadian sales force, the benefitS.A.d risks of BLEXTEN, BLEXTEN aS.A. additional treatment option that physicians can offer Canadian patients suffering from S.A.onal allergieS.A.d hives, BLEXTEN playing a role in driving organic growth of the Canadian business, BLEXTEN aS.A. innovative drug and entitled to an eight-year term of data protection (market exclusivity), the estimated value of the Canadian antihiS.A.ine 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 S.A.ements that are not historical facts, and such S.A.ementS.A.e 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 S.A.ementS.A.e expressed differently.
You should be aware that the forward-looking S.A.ements included herein represent management's current judgment and expectations, and are based on current estimateS.A.d assumptions made by management in light of its experience and perception of historical trends, current conditionS.A.d expected future developments, as well as other factors that it believeS.A.e appropriate and reasonable under the circumS.A.ces, but there can be no assurance that such estimateS.A.d assumptions will prove to be correct and, aS.A.result, the forward-looking S.A.ements 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 S.A.ements. Our operations involve riskS.A.d uncertainties, many of which are outside of our control, and any one or any combination of these riskS.A.d uncertainties could also affect whether the forward-looking S.A.ements 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 S.A.ements. These riskS.A.d uncertainties include, without limitation, our inability to build, acquire or contract with a sales force of sufficient S.A.e for the commercialization of our products in a timely and cost-effective manner; our failure to successfully commercialize our productS.A.d product candidates; competition, including increased generic competition; costS.A.d 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 S.A.dards 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.A.d 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 neceS.A.y for the development, manufacture, commercialization, marketing, saleS.A.d distribution of any products, including our dependence on AstraZeneca AB and Horizon Pharma USA, Inc. for the saleS.A.d 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.A.d 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.A.; 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.A.d unanticipated tax liabilitieS.A.d 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.A.d Exchange Commission (SEC) filingS.A.d reportS.A.d 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 S.A.ementS.A.d should not rely upon this information as of any other date. We undertake no obligation to publicly update or revise any forward-looking S.A.ements, whether aS.A.result of new information, future events or otherwise, unless required by law.
Source: Aralez Pharmaceuticals
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