On July 29, 2021 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, reported that its wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare ("Miravo Ireland"), reported that it 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") (Press release, Nuvo Pharmaceuticals, JUL 29, 2021, View Source [SID1234585409]).
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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.