- 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.
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.
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