Nuvo Pharmaceuticals™ Announces United States District Court Denies Dr. Reddy's Laboratories Motion for Summary Judgment of Nuvo's '996 and '920 VIMOVO Patents
November 11, 2019
VIMOVO Litigation to Continue
MISSISSAUGA, ON, Nov. 11, 2019 /CNW/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI; OTCQX:NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that the United States District Court for the District of New Jersey has denied a motion for summary judgment filed by Dr. Reddy's Laboratories Inc. (DRL). As a result, the patent infringement litigation against DRL, involving Nuvo Pharmaceuticals (Ireland) DAC's (Nuvo Ireland) U.S. Patent Nos. 8,858,996 and 9,161,920 (the '996 and '920 patents), will continue.
The parties have mutually agreed on a pre-trial litigation schedule with the court through to April 2021. The term of the '996 and '920 patents extends to May 31, 2022.
While the litigation is pending, DRL may still launch its generic version of VIMOVO "at risk" upon approval by the U.S. Food and Drug Administration (FDA). If an "at risk" launch occurs, Nuvo Ireland and its U.S. partner can continue to enforce the '996 and '920 patents against DRL and seek damages. As of the close of business on Friday, November 8, 2019, the FDA had not issued final approval of DRL's generic VIMOVO abbreviated new drug application (ANDA).
DRL was the first filer of an ANDA for a generic version of VIMOVO in the U.S., and thus, was eligible for a 180-day period of marketing exclusivity vis-à-vis other generic applicants of VIMOVO . The U.S. regulations provide a number of conditions under which the first filer may forfeit eligibility of this 180-day exclusivity, including failure to market. The FDA has not yet determined whether DRL has forfeited this exclusivity, but it is the Company's understanding of the regulations that because DRL did not commence commercial activity in the U.S. prior to October 20, 2019, they may have forfeited this exclusivity. Consequently, if DRL launches a generic version of VIMOVO in the U.S., then other generic companies that have final FDA approval may also launch.
"We are pleased with Judge Chesler's decision," stated Tina Loucaides, Nuvo's Vice President, Secretary and General Counsel. "We believe these patents are valid and enforceable and will continue to enforce Nuvo Ireland's rights against DRL."
A launch of a generic version of VIMOVO in the U.S. does not impact the Company's global VIMOVO business in markets outside of the U.S. Nuvo will continue to receive royalty payments from its global partner, Grunenthal GmbH on global net sales of VIMOVO.
VIMOVO (naproxen/esomeprazole magnesium) is the brand name for a proprietary fixed-dose combination of enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole magnesium, a proton pump inhibitor, in a single delayed-release tablet. VIMOVO was originally developed in collaboration with AstraZeneca. On April 30, 2010, the FDA approved VIMOVO for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is currently commercialized in the U.S. by Horizon Therapeutics plc and Grunenthal GmbH in various rest of world territories, including Canada, Europe and select additional countries.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX: NRI; OTCQX: NRIFF) 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. Nuvo's head office is located in Mississauga, Ontario, Canada, the international operations are located in Dublin, Ireland and the U.S. Food and Drug Administration (FDA), Health Canada and E.U. approved 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. For additional information, please visit www.nuvopharmaceuticals.com.
This press release contains "forward-looking information" as defined under Canadian securities laws (collectively, "forward-looking statements"). The words "plans", "expects", "does not expect", "goals", "seek", "strategy", "future", "estimates", "intends", "anticipates", "does not anticipate", "projected", "believes" or variations of such words and phrases or statements to the effect that certain actions, events or results "may", "will", "could", "would", "should", "might", "likely", "occur", "be achieved" or "continue" and similar expressions identify forward-looking statements. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking statements.
Forward-looking statements are not historical facts but instead represent management's expectations, estimates and projections regarding future events or circumstances. Such forward-looking statements are qualified in their entirety by the inherent risks, uncertainties and changes in circumstances surrounding future expectations which are difficult to predict and many of which are beyond the control of the Company. Forward-looking statements are necessarily based on a number of estimates and assumptions that, while considered reasonable by management of the Company as of the date of this press release, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Material factors and assumptions used to develop the forward-looking statements, and material risk factors that could cause actual results to differ materially from the forward-looking statements, include but are not limited to, the validity of the '907 and '285 Patents claims, the outcome of ongoing patent litigation and other factors, many of which are beyond the control of Nuvo. Additional 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 28, 2019 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. When relying on forward-looking statements to make decisions, the Company cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. Forward-looking statements should not be read as guarantees of future performance or results and will not necessarily be accurate indications of whether or not the times at or by which such performance or results will be achieved.
All forward-looking statements are based only on information currently available to the Company and are made as of the date of this press release. Except as expressly required by applicable Canadian securities law, the Company assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements in this press release are qualified by these cautionary statements.
SOURCE Nuvo Pharmaceuticals Inc.
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