MISSISSAUGA, ON, March 28, 2017 /PRNewswire/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today announced that it has entered into an exclusive license agreement with Sayre Therapeutics PVT Ltd. (Sayre Therapeutics) to distribute, market and sell Pennsaid 2% in India, Sri Lanka, Bangladesh and Nepal (the Territory). 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.
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.
Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, the future approval, marketing and sale of Pennsaid 2% in certain jurisdictions, as well as statements with respect to management's beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "believe", "should" or "plans", or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include, but are not limited to, general business and economic uncertainties and adverse market conditions; as well as other risk factors included in the Company's Management Information Circular dated December 31, 2015 and the Company's Annual Information Form dated March 1, 2017 under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on the Company's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. Although the forward-looking information contained in this press release is based upon what management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. All forward-looking statements in this press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Nuvo Pharmaceuticals Inc.