Healthcare Industry News: S.A.
News Release - April 25, 2016
Aralez Receives Health Canada Approval For BLEXTEN(TM)
MILTON, Ontario, April 25, 2016 -- (Healthcare Sales & Marketing Network) -- Aralez Pharmaceuticals Inc. (ARLZ) (ARZ.TO) ("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 S.A.onal Allergic Rhinitis (SAR) and Chronic Spontaneous Urticaria (CSU) (such as itchinesS.A.d 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.A. opportunity to introduce the first new antihiS.A.ine in Canada in over 15 years," 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. BLEXTEN, is patent protected and qualifies for 8 years of market exclusivity under Health Canada's Office of Patented MedicineS.A.d 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 SusS.A., MD, FRCPC, a Canadian renowned allergy clinical immunology specialist, "A new antihiS.A.ine 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 antihiS.A.ine therapy for patients with allergic rhinitis, physicians can look to the revised ARIA 2010 recommendations for further guidance."
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 Canadian antihiS.A.ine 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.A.e 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).
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, 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 S.A.n by FAES Farma, S.A. BLEXTEN iS.A.proved in Canada and approximately 90 countries including the European Union. Bilastine has not yet been submitted in the United S.A.es.
The Company haS.A. exclusive license agreement with Faes Farma, S.A., a S.A.ish pharmaceutical company, to sell and market BLEXTEN in Canada for the treatment of SAR and CSU.
About Aralez Pharmaceuticals Inc.
Aralez Pharmaceuticals Inc. (ARLZ) (ARZ.TO) iS.A.global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while focusing on 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 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 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, BLEXTEN representing an additional treatment option that physicians can offer Canadian patients suffering from S.A.onal allergieS.A.d 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.A.d 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. ReaderS.A.e cautioned that actual future operating resultS.A.d economic performance of the Company, including with respect to the forward-looking S.A.ements referred to above, are subject to a number of riskS.A.d 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.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 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.A.d the medical community, costS.A.d 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 S.A.dards 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 neceS.A.y for the development, manufacture, commercialization, marketing, saleS.A.d distribution of any products, including our dependence on AstraZeneca and Horizon for the saleS.A.d 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.A.d 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.A.d 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.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 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.A.d Exchange Commission 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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