European Patent Office Rules in Favor of Exelixis on Formulation Patent Covering CABOMETYX® (cabozantinib) Tablets
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The successful defense of Exelixis Inc.'s European patent EP2593090 represents a significant victory for the company, particularly in the competitive landscape of pharmaceuticals. The patent covers tablet formulations of cabozantinib, a therapeutic agent that has shown efficacy in treating various forms of cancer, including renal cell carcinoma and hepatocellular carcinoma. The ruling ensures Exelixis maintains exclusive rights to market CABOMETYX tablets in Europe until July 2031, barring successful appeals.
Market exclusivity is critical for recouping research and development investments and can provide a substantial revenue stream. The decision to uphold the patent against challenges by generic manufacturers like STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd. and Generics (U.K.) Ltd. prevents early market entry of generic equivalents. This delay in generic competition can sustain higher pricing for CABOMETYX, which is beneficial for Exelixis's financial health and attractiveness to investors.
From a market perspective, the affirmation of Exelixis's patent rights in Europe could potentially lead to a positive reaction in the company's stock price as it alleviates investor concerns over immediate generic competition. The pharmaceutical industry is highly sensitive to patent litigation outcomes due to their significant impact on company revenues and market share. With the European Medicines Agency's approval of CABOMETYX, Exelixis has a clear pathway to capitalize on the European market without the immediate threat of generics.
However, investors should also consider the potential for an appeal to the EPO Technical Boards of Appeal. While the current decision is favorable, the uncertainty of an appeal process could introduce volatility in the company's stock. Furthermore, the company's reliance on cabozantinib as a key revenue driver underscores the importance of diversifying its product portfolio to mitigate risks associated with patent expiration or successful future challenges.
The legal implications of the EPO's decision to uphold Exelixis's patent are noteworthy. The three-member panel's rejection of all grounds of opposition indicates a robust defense of the patent's claims, which could set a precedent for future pharmaceutical patent defenses. The ability to defend against such challenges is a testament to the strength of the patent's original filing and the company's legal strategy.
It is important to understand that the European patent system allows for post-grant opposition, which is a procedure where third parties can challenge the validity of a granted patent. This case highlights the critical nature of having a strong patent portfolio and proactive legal defense to protect key assets in the pharmaceutical industry. While the decision is subject to appeal, the initial ruling provides a temporary reprieve and a strategic advantage for Exelixis in the European market.
About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to the outcome of the EPO ruling and the potential for appeal of the EPO decision. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the factors detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.
Exelixis, the Exelixis logo and CABOMETYX are registered
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Exelixis Investors Contact:
Susan Hubbard
EVP, Public Affairs and
Investor Relations
(650) 837-8194
shubbard@exelixis.com
Exelixis Media Contact:
Claire McConnaughey
Senior Director,
Public Affairs
(650) 837-7052
cmcconn@exelixis.com
Source: Exelixis, Inc.
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