Nuvo Pharmaceuticals® Announces The Canadian Commercial Launch of Suvexx™ - For The Acute Treatment of Migraine

- Combination of sumatriptan succinate and naproxen sodium in a single tablet -

MISSISSAUGA, ON, Sept. 9, 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 launched Suvexx™ into the approximately $130 million Canadian prescription acute migraine market. 

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.  Suvexx helps patients manage acute migraine attacks using a combination of sumatriptan succinate and naproxen sodium in a single tablet.  In thirteen phase 3 studies, Suvexx demonstrated early and sustained efficacy superior to sumatriptan and naproxen alone with a safety and tolerability profile similar to sumatriptan and naproxen.  Thousands of patients were treated during the development program including patients with menstrual migraine and patients intolerant of other currently approved migraine medications.

"Suvexx was approved by Health Canada in late February of this year and the subsequent launch of Suvexx by our commercial team supports our strategy of building on our existing commercial presence in Canada and expanding our portfolio of migraine treatments.  Suvexx adds an additional potential revenue-generating product to our strong product portfolio," said Jesse Ledger, Nuvo's President & Chief Executive Officer.  "We have established relationships with neurologists and physicians who treat migraineurs across Canada through our 7 years of promoting Cambia, our first medication used to treat acute migraine."

"Migraine is a neurological disease that impacts close to three million Canadians, the majority of them, women.  Migraines are more severe and debilitating than other types of headaches and, consist of moderate to severe throbbing or pulsating pain and are often on one side of the head.  Other debilitating symptoms include nausea; vomiting; and hypersensitivity to lights, sounds and smells.  Migraine patients suffer with a diminished quality of life and reduced productivity surrounding their migraine attacks.  Until recently, physicians have been challenged to find appropriate acute therapies to abort a patient's migraine attack.  Our goal is to prescribe medications that provide patients with sustained pain free relief, low recurrence rates of the migraine attack, and with few to no side effects.  With the addition of Suvexx to the Canadian market, patients will have a new and innovative option to treat their migraine attacks that is supported by strong clinical data.  The introduction of this novel "combination therapy" will be a welcome addition to my clinical practice." 

Ian Finkelstein, MD
Director, Toronto Headache & Pain Clinic

"The entry of Suvexx into the Canadian market provides migraine sufferers with an innovative treatment for acute migraine supported by strong clinical data.  Suvexx, a combination of sumatriptan succinate and naproxen sodium in a single tablet, provides a novel approach for treating acute migraine.  Clinical trials involving thousands of migraineurs demonstrated efficacy and a safety profile that makes me confident in prescribing Suvexx to patients suffering with acute migraine attacks."

Elizabeth Leroux, MD, FRCPC
Headache Neurologist in Montreal and
President of the Canadian Headache Society

"Migraine is a neurological condition which can significantly reduce a sufferers quality of life. Migraineurs experience recurrent debilitating symptoms that affect day-to-day activities, including home life, hobbies, social relationships and work.  Many Canadian migraineurs are dissatisfied with their current treatments.  Migraineurs and the physicians who care for them welcome the availability in Canada of innovative acute migraine therapies such as Suvexx that increase the likelihood that migraine sufferers can better control their migraines and improve their quality of life."

Dr. Jonathan Gladstone, MD FRCPC
Director, Gladstone Headache Clinic
Consultant Neurologist, Headache Clinic, Hospital for Sick Children
Consultant Neurologist, Cleveland Clinic Canada
Consultant Neurologist, Toronto Raptors

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 Suvexx) 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 Company's 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 U.S. Food and Drug Administration.  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, including the anticipated receipt of certain milestone and royalty payments, the anticipated launch of certain products and the potential impact of COVID-19. 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 and may prove to be incorrect. 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 to, the validity of the '907 and '285 Patents claims, the outcome of ongoing patent litigation, the potential impact of COVID-19 on the Company's operations, business and financial results 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. 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.

SOURCE Nuvo Pharmaceuticals Inc.

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