Dec 14, 2017, 07:30 ET
MISSISSAUGA, ON, Dec. 14, 2017 /CNW/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX: NRI; OTCQX: NRIFF), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today announced it has entered into a license and distribution agreement (License Agreement) with Gebro Pharma AG (Gebro Pharma) for the exclusive right to register, distribute, market and sell Pennsaid® 2% in Switzerland and Liechtenstein (the Territory). Gebro Pharma AG is the Switzerland-based affiliate of Gebro Holding GmbH, an Austrian-based pharmaceutical company with a commercial presence via subsidiaries and partners in over 25 countries globally.
"We are extremely pleased to partner Pennsaid 2% with Gebro Pharma in Switzerland and Liechtenstein," said Jesse Ledger, Nuvo's President & CEO. "Gebro Pharma's strong presence in rheumatology, pain and over-the-counter brands make it an ideal partner for Nuvo in this region. This transaction is an example of our ongoing progress towards making Pennsaid 2% a global brand."
Marcel Plattner, CEO, Gebro Pharma said, "Our collaboration with Nuvo allows us to bring a novel, best-in-class treatment for osteoarthritis to patients in Switzerland and Liechtenstein. Pennsaid 2% adds an additional first-line treatment option to our growing portfolio of pain and rheumatology medicines."
License Agreement Details
The License Agreement grants Gebro Pharma the exclusive rights throughout the Territory to register, market, sell and distribute Pennsaid 2% as a non-prescription drug for the human treatment of osteoarthritis of the knee and acute pain from sprains and strains. Nuvo will provide Gebro Pharma with its existing Pennsaid 2% regulatory dossier and the U.S. Food and Drug Administration (FDA) approval of Pennsaid 2%, which Gebro Pharma will use to support its application for regulatory approvals in Switzerland and Liechtenstein. Nuvo is eligible to receive milestone payments and royalties on net sales of Pennsaid 2% in the Territory and will earn product revenue from Gebro Pharma pursuant to an exclusive supply agreement. Pennsaid 2% is manufactured at the Company's facility in Varennes, Québec.
About Pennsaid 2%
Pennsaid 2% is a 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 Gebro Pharma AG
Gebro Pharma AG is the Switzerland-based affiliate of Gebro Holding GmbH, a successful Austrian-based pharmaceutical company. Gebro Pharma specializes in the commercialization of innovative pharmaceutical products for both prescription and over-the-counter use. Gebro Pharma is an excellent partner for the Swiss market with a strong market presence in rheumatology, pain and dermatology, as well as for over-the-counter products. The added-value products and services in Gebro Pharma's portfolio are designed to enhance our patients' quality of life.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX: NRI; OTCQX: NRIFF) 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) 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.
This Press Release contains "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on the Company's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Nuvo's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, readers should not rely on any of these forward-looking statements. Important factors that could cause Nuvo's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Nuvo's most recent 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 Nuvo with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo'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 none of Nuvo or any other person assumes responsibility for the accuracy and completeness of these forward-looking statements.
Any forward-looking statement made by the Company in this Press Release is based only on information currently available to it and speaks only as of the date on which it is made. Except as required by applicable securities laws, Nuvo undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
SOURCE Nuvo Pharmaceuticals Inc.
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