Nuvo Pharmaceuticals Inc. (TSX: NRI) (OTCQX: NRIFF) d/b/a Miravo Healthcare ("Miravo" or the "Company"), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that its wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare ("Miravo Ireland"), has entered into an exclusive license and supply agreement (the "License Agreement") with SK Chemicals Co., Ltd. ("SK Chemicals") for the exclusive right to commercialize Suvexx in the Republic of South Korea (the "Territory").

SK Chemicals is headquartered in Seongnam, South Korea and is part of the SK Group, a major South Korean conglomerate that generated over US$105 billion in revenue in 2020. SK Chemicals generated US$1.0 billion in sales in 2020 and has Korean partnerships with many multinational pharmaceutical companies including Eli Lilly, AstraZeneca and Janssen. 

The commercial launch of Suvexx in the Territory is anticipated to commence in 2023, subject to receipt of regulatory approval from the local regulatory authorities.  Upon regulatory approval, Suvexx is anticipated to be entitled to 6 years of marketing exclusivity in the Territory.  The South Korean prescription acute migraine treatment market was valued at over US$20 million in 2020 based on IQVIA domestic data.

"This agreement with SK Chemicals provides Suvexx with access to the dynamic and growing acute migraine market in South Korea," said Jesse Ledger, Miravo's President & CEO.  "SK Chemicals is a strong partner for Suvexx in South Korea with their complementary CNS product portfolio, and we are pleased to add them to our growing roster of Suvexx partners." 

License Agreement Details

The License Agreement grants SK Chemicals the exclusive rights to commercialize Suvexx in the Territory.  SK Chemicals will be responsible for obtaining and maintaining the marketing authorizations for Suvexx in the Territory and will also manage all Territory specific commercial activities.  Miravo Ireland will receive up to EUR 1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in the Territory and revenue pursuant to the supply of product.  Suvexx is currently manufactured by the Company's contract manufacturing partner in the United States.

About Suvexx

Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was originally 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 Miravo) 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.  Miravo owns the product and intellectual property rights to Suvexx in Canada and Miravo Ireland owns the intellectual property rights to Suvexx outside of Canada.

About SK Chemicals Co., Ltd. 

SK Chemicals is committed to perform practices from research & development to marketing activities in South Korea.  The company is well known for extensive domestic market coverage with talented sales representatives, facilitating the company's balanced pipeline.  As an affiliate of SK Group, the huge conglomerate in Korea having total revenue over US$105 billion as of year 2020, SK Chemicals has been rapidly growing its Life Science business domain and its annual sales reached US$1.0 billion in year 2020.  SK Chemicals is committed to both R& D and marketing activities with its vision to become a leading global total healthcare solutions provider.  Through such commitment, SK Chemicals has grown into one of the major pharmaceutical companies in Korea since its establishment in 1969.  

About Miravo Healthcare

Miravo 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.  Miravo'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.