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Nuvo Pharmaceuticals (TSX:NRI) announced an exclusive license agreement with Sayre Therapeutics to distribute, market and sell Pennsaid 2% in India, Sri Lanka, Bangladesh, and Nepal.
Nuvo Pharmaceuticals (TSX:NRI) announced an exclusive license agreement with Sayre Therapeutics to distribute, market and sell Pennsaid 2% in India, Sri Lanka, Bangladesh, and Nepal.
As quoted in the press release:
Nuvo has received an upfront payment and is eligible to receive milestone payments and a double-digit royalty on net sales. Nuvo will supply Pennsaid 2% to Sayre on an exclusive basis from its manufacturing facility in Varennes, Québec.
“We are extremely pleased that our very capable and committed new partner, Sayre Therapeutics, will represent the Pennsaid 2% brand in this significant South Asian region,” said Jesse Ledger, Nuvo’s President. “We expect to complete Pennsaid 2% out-licensing agreements for other territories throughout 2017 and 2018. Our strategy is to make Pennsaid 2% a global brand which will increase and diversify our revenue streams and increase capacity utilization at our manufacturing facility.”
Shukrit Chimote, CEO, Sayre Therapeutics said, “Our collaboration with Nuvo helps us bring a U.S. FDA approved best-in-class solution to South Asia. Pennsaid adds an additional first-line treatment option to our growing portfolio of rheumatology medicines. Pennsaid 2% will greatly benefit the South Asian patient community and improve their quality of life.”
License Agreement Details
The License Agreement grants Sayre the exclusive right throughout the Territory to market, sell and distribute Pennsaid 2% as a prescription drug for the human treatment of osteoarthritis of the knee and acute pain from sprains and strains. Nuvo will provide Sayre with its existing Pennsaid 2% regulatory dossier and the U.S. Food and Drug Administration (FDA) approval of Pennsaid 2% which Sayre will use to support its application for regulatory approvals in the countries within the Territory.
About Pennsaid 2%
Pennsaid 2% is topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium. It is approved by the FDA for treating the pain of osteoarthritis of the knee(s). Pennsaid 2% is a gel formulation that is supplied in a metered dose pump bottle. It is the only topical NSAID approved by the FDA for twice daily dosing. Pennsaid 2% is protected by multiple U.S. patents that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations database or Orange Book. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories. Pennsaid 2% has not yet received regulatory approval outside of the U.S. and Russia.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch. Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ: HZNP), is approved for sale, but has not yet been commercially launched, in Russia and is available for partnering in certain other territories around the world. Nuvo manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA, Health Canada and E.U. approved manufacturing facility in Varennes, Québec. For additional information, please visit www.nuvopharmaceuticals.com.
About SAYRE:
M/S Sayre Therapeutics Private Ltd. is South Asia’s only integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics and drug-delivery devices in the super-specialty areas of Oncology and Immunology/Rheumatology. Sayre Therapeutics was founded in 2015 backed by leading global venture capital firms. The Sayre team boasts 25 years of global executive experience in leading Pharmaceuticals, Medical Diagnostics & Devices companies. Sayre is creating a portfolio of differentiated global assets in emerging markets, including India, Pakistan, Sri Lanka and Nepal which are witnessing high growth for pharmaceutical products. Sayre has a geographically focused strategy, strong financial backing and established relationships with clinicians and regulatory know-how, and will be a committed partner to licensors like Nuvo Pharmaceuticals for their global assets.
