Miravo Healthcare™ Announces Summary Judgment Ruling by the United States District Court for the District of New Jersey

Rhea-AI Summary

Nuvo Pharmaceuticals announced that the U.S. District Court found its patents for Vimovo invalid, affecting its business in the U.S.

Despite this ruling, its Irish subsidiary will continue to receive royalty payments from U.S. and global partners. In Q3 2021, Miravo earned $0.2 million in royalties on U.S. Vimovo sales. The company is evaluating its options in light of the court's decision.

Positive

• Miravo continues to earn royalties from U.S. and global partners under license agreements.
• In Q3 2021, Miravo earned $0.2 million in royalties from U.S. Vimovo sales.

Negative

• The ruling invalidates U.S. patents for Vimovo, impacting its market position in the U.S.

- U.S. Patent Nos. 8,858,996 and 9,161,920 (the '996 and '920 patents) covering Vimovo in the U.S. have been found to be invalid -

MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), 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 granted Dr. Reddy’s Laboratories Inc.’s (DRL) motion for Summary Judgment, finding the asserted claims of the ‘996 and ‘920 patents invalid. Miravo’s wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC d/b/a Miravo Healthcare (Miravo Ireland) is evaluating the court’s decision and is assessing its options.

This ruling in the U.S. does not impact Miravo Ireland’s global Vimovo business in markets outside of the U.S. Miravo Ireland will continue to receive royalty payments from its U.S. and global partners under the terms of the license agreements. Miravo Ireland earned a $0.2 million royalty on U.S. net sales of Vimovo during the three months ended September 30, 2021 (the Company’s last reported quarter).

About Miravo Healthcare
Miravo is a Canadian-focused, healthcare company with global reach and a diversified portfolio of commercial products. The Company’s products target several therapeutic areas, including pain, allergy, neurology and dermatology. The Company’s strategy is to in-license and acquire growth-oriented, complementary products for Canadian and international markets. Miravo’s head office is located in Mississauga, Ontario, Canada, the international operations are located in Dublin, Ireland and the Company’s 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.miravohealthcare.com.

Forward-Looking Statements
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. These forward-looking statements include statements regarding anticipated product launches, responses to COVID-19, milestone payments, royalties and license approvals.

Forward-looking statements are not historical facts but instead represent management’s expectations, estimates and projections regarding future events or circumstances, including the anticipated receipt of certain milestone and royalty payments, the anticipated launch of certain products and approvals therefor, and the potential impact of COVID-19. 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 and may prove to be incorrect. 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 denial of regulatory approvals, the delay or failure to meet anticipated product launches, the failure to meet certain milestones or collect certain royalties, the potential impact of COVID-19 on the Company’s operations, business and financial results and other factors, many of which are beyond the control of the Company. Additional factors that could cause the Company’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 the Company’s most recent Annual Information Form dated March 5, 2021 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. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220228005293/en/

Investor Relations

Stefan Eftychiou

905 326 1888 ext 60

stefan@bristolir.com

Source: Nuvo Pharmaceuticals Inc.

FAQ

What was the recent court ruling regarding Miravo's patents on Vimovo?

The U.S. District Court granted Dr. Reddy’s Laboratories' motion, finding Nuvo Pharmaceuticals' patents for Vimovo invalid.

How does the court ruling affect Miravo's business?

The ruling impacts Vimovo's market position in the U.S., but Miravo's Irish subsidiary will still receive royalty payments.

What royalties did Miravo earn from Vimovo sales in Q3 2021?

Miravo earned $0.2 million in royalties from U.S. net sales of Vimovo during Q3 2021.

Is Miravo evaluating its options after the court decision?

Yes, Miravo is assessing the court's decision and evaluating its options going forward.

Does the court ruling affect Miravo's global Vimovo business?

No, the ruling does not impact Miravo Ireland's global Vimovo business outside the U.S.