Theravance Biopharma Enters Settlement Agreement with Eugia; Focuses on COPD Treatment and Neurogenic Orthostatic Hypotension Drug Development

Theravance Biopharma, a biopharmaceutical company, has entered a settlement agreement with Eugia. The company's focus is on developing and commercializing medicines, including YUPELRI for chronic obstructive pulmonary disease (COPD) maintenance treatment and Ampreloxetine for symptomatic neurogenic orthostatic hypotension.

Theravance Biopharma, Inc. (NASDAQ:TBPH), a biopharmaceutical company focused on developing and commercializing medicines for chronic obstructive pulmonary disease (COPD) and other conditions, has entered a settlement agreement with Eugia Pharma Specialities Ltd. The settlement, detailed in a recent SEC filing, resolves ongoing patent litigation over the drug YUPELRI® (revefenacin) inhalation solution [1].

The litigation stemmed from Eugia’s filing of an abbreviated new drug application (ANDA) to market a generic version of YUPELRI® before the expiration of Theravance and Mylan’s patents. The patents in question include several U.S. Patent Nos., such as 8,541,451 and 12,285,417, among others. Under the terms of the settlement, Theravance and Mylan have granted Eugia a royalty-free, non-exclusive license to manufacture and market its generic version of YUPELRI® in the United States starting April 23, 2039. This agreement is subject to customary exceptions and regulatory review by the U.S. Department of Justice and the Federal Trade Commission [1].

The settlement resolves the dispute with Eugia but does not affect ongoing litigation with other ANDA filers, including Cipla (NSE:CIPL) Limited and Mankind Pharma Ltd. The settlement is part of Theravance’s strategy to protect its intellectual property while allowing for eventual generic competition.

In recent financial news, Theravance Biopharma reported mixed results for the first quarter of 2025. The company posted an earnings per share (EPS) of -$0.27, falling short of the expected -$0.22, while revenue slightly exceeded forecasts, reaching $15.4 million. Despite the EPS miss, Theravance Biopharma saw a 6% year-over-year revenue increase, supported by strong sales growth in key product lines, YUPELRI and TRELEGY. The company ended the quarter with $131 million in cash and no debt, maintaining a strong financial position [1].

Additionally, Sanofi and Regeneron have announced results from two Phase III clinical trials evaluating the efficacy of itepekimab, a fully human monoclonal antibody, as a potential treatment for COPD. The trials, named AERIFY-1 and AERIFY-2, were conducted to assess the drug’s ability to reduce exacerbations in COPD patients who are former smokers. The findings from the AERIFY-1 trial revealed that itepekimab met its primary endpoint by significantly reducing moderate-to-severe COPD exacerbations compared to placebo. In contrast, the AERIFY-2 trial did not achieve its primary endpoint [2].

Sanofi's share price fell 5% over the last week, despite the positive news from the AERIFY-1 trial. This decline may reflect investors’ reactions to other company initiatives, such as its partnership with Stagecoach Performing Arts to raise awareness of autoimmune Type 1 diabetes. Looking at a longer-term context, Sanofi's shares have delivered a total return of 19.59% over the past five years, with recent performance exceeding the French Pharmaceuticals industry and market [3].

References:
[1] https://www.investing.com/news/sec-filings/theravance-biopharma-settles-patent-litigation-with-eugia-pharma-93CH-4084697
[2] https://www.geneonline.com/sanofi-and-regeneron-report-mixed-results-in-phase-iii-trials-of-itepekimab-for-copd-treatment/
[3] https://finance.yahoo.com/news/sanofi-enxtpa-san-reports-positive-171933863.html