Nuvo Pharmaceuticals® Announces Health Canada Approves Suve

|Feb 27|magazine17 min read

- Canadian Launch Anticipated in the Second Half of 2020 -

MISSISSAUGA, ON, Feb. 27, 2020 /PRNewswire/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX: NRI; OTCQX: NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that its wholly owned subsidiary, Aralez Pharmaceuticals Canada Inc. (Aralez Canada) has received a Notice of Compliance from Health Canada for Suvexx™.  Suvexx (sumatriptan succinate and naproxen sodium tablets) is a fixed-dose combination prescription medication, indicated for the acute treatment of migraine attacks with or without aura in adults. Aralez Canada anticipates launching Suvexx into the approximately $130 million Canadian prescription acute migraine market in the second half of 2020. 

"The approval of Suvexx by Health Canada supports our growth strategy of building our commercial presence in Canada with new and innovative medicines.  Suvexx was one of the assets acquired during the acquisition of the Aralez Canada business and we are pleased to be able to bring Suvexx to market so quickly after closing that transaction," said Jesse Ledger, Nuvo's President & Chief Executive Officer.  "We will leverage our existing relationships with neurologists and physicians who treat migraineurs across Canada to support and grow the Suvexx brand.  These relationships were established from our 7 years of growing Cambia.  Our Canadian commercial team has already initiated pre-commercial launch activities."

Migraine patients suffer with a diminished quality of life and reduced productivity surrounding migraine attacks.  Suvexx helps patients manage acute migraine attacks using a combination of sumatriptan succinate and naproxen sodium in a single tablet.  

"The clinical development of Suvexx was extensive and included a total of 13 phase 3 studies, treating thousands of patients, to examine acute migraine, menstrual migraine and patients intolerant of other currently approved migraine medications.  Suvexx demonstrated early and sustained efficacy superior to sumatriptan and naproxen alone with a safety and tolerability profile similar to sumatriptan and naproxen.  We see Suvexx as an excellent addition to the health care professionals tool kit to help manage their patients' migraines," said Dr Bernard Chiasson, Nuvo's Chief Scientific Officer.

About Suvexx

Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. (POZEN) in collaboration with Glaxo Group Limited, d/b/a GSK (GSK).  The product is formulated with POZEN's patented technology (now owned by Aralez Canada) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK's RT Technology in a single tablet.  In 2008, the U.S. Food and Drug Administration (FDA) approved Treximet (the U.S. brand name) for the acute treatment of migraine attacks, with or without aura, in adults.  Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC.  Aralez Canada owns the product and intellectual property rights to Suvexx in Canada and Nuvo Pharmaceuticals (Ireland) DAC owns the intellectual property rights to Suvexx outside of Canada.

About Nuvo Pharmaceuticals Inc.

Nuvo (TSX: NRI; OTCQX: NRIFF) is a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products.  The Company targets several therapeutic areas, including pain, allergy and dermatology.  The Company's strategy is to in-license and acquire growth-oriented, complementary products for Canadian and international markets.  Nuvo's head office is located in Mississauga, Ontario, Canada, the international operations are located in Dublin, Ireland and the U.S. Food and Drug Administration (FDA), Health Canada and E.U. approved manufacturing facility is located in Varennes, Québec, Canada.  The Varennes facility operates in a Good Manufacturing Practices (GMP) environment respecting the U.S, Canada and E.U. GMP regulations and is regularly inspected by Health Canada and the FDA.  For additional information, please visit www.nuvopharmaceuticals.com.

Forward-Looking Statements
This press release contains "forward-looking information" as defined under Canadian securities laws (collectively, "forward-looking statements"). The words "plans", "expects", "does not expect", "goals", "seek", "strategy", "future", "estimates", "intends", "anticipates", "does not anticipate", "projected", "believes" or variations of such words and phrases or statements to the effect that certain actions, events or results "may", "will", "could", "would", "should", "might", "likely", "occur", "be achieved" or "continue" and similar expressions identify forward-looking statements. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking statements. 

Forward-looking statements are not historical facts but instead represent management's expectations, estimates and projections regarding future events or circumstances. Such forward-looking statements are qualified in their entirety by the inherent risks, uncertainties and changes in circumstances surrounding future expectations which are difficult to predict and many of which are beyond the control of the Company. Forward-looking statements are necessarily based on a number of estimates and assumptions that, while considered reasonable by management of the Company as of the date of this press release, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Material factors and assumptions used to develop the forward-looking statements, and material risk factors that could cause actual results to differ materially from the forward-looking statements, include but are not limited the outcome of ongoing patent litigation and other factors, many of which are beyond the control of Nuvo.  Additional factors that could cause Nuvo's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Nuvo's most recent Annual Information Form dated February 24, 2020 under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by Nuvo with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo's forward-looking statements. When relying on forward-looking statements to make decisions, the Company cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. Forward-looking statements should not be read as guarantees of future performance or results and will not necessarily be accurate indications of whether or not the times at or by which such performance or results will be achieved.

All forward-looking statements are based only on information currently available to the Company and are made as of the date of this press release. Except as expressly required by applicable Canadian securities law, the Company assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements in this press release are qualified by these cautionary statements.

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SOURCE Nuvo Pharmaceuticals Inc.