Key Points from the Report

• Federal Court Ruling: The United States Court of Appeals for the Federal Circuit has upheld a previous verdict that Teva Pharmaceuticals’ marketing of a generic version of Korlym® does not infringe two of Corcept’s patents. These patents pertain to methods of safely co-administering Korlym with drugs that inhibit the CYP3A4 enzyme, which are frequently prescribed to Cushing’s syndrome patients.
• Patent Protection Challenged: The affirmed verdict originated from the Federal District Court for the District of New Jersey in December 2023, representing a significant legal setback for Corcept’s intellectual property protection regarding Korlym®.
• Company Response: Dr. Joseph K. Belanoff, CEO of Corcept Therapeutics, expressed disappointment in the ruling and emphasized the importance of the patents in safeguarding treatment methods for Cushing’s syndrome. The company intends to vigorously defend its rights and is actively considering options for judicial review.
• Business Overview: Corcept has been a leader in cortisol modulation for over 25 years, with more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. The company is currently conducting advanced clinical trials in hypercortisolism, solid tumors, ALS, and liver disease.
• Korlym® Background: Korlym® was introduced in 2012 as the first FDA-approved drug for endogenous hypercortisolism. It remains a foundational product for Corcept.

Important Information for Shareholders

• Potential Impact on Revenue: The court’s ruling may enable Teva Pharmaceuticals to market a generic version of Korlym® without infringing Corcept’s patents, posing a risk to Corcept’s revenue from Korlym®. The loss of patent protection could potentially result in increased competition and reduced market exclusivity, which may negatively affect share values.
• Legal Strategy and Uncertainty: Corcept’s statement about exploring judicial review indicates that the legal battle is not yet over. Investors should monitor further legal developments, as successful judicial review could restore some protection, while failure could cement the loss of exclusivity.
• Ongoing Clinical Pipeline: Despite the setback, Corcept continues to invest in research and development across multiple therapeutic areas, potentially offsetting losses from Korlym® if new products succeed.
• Forward-Looking Statements: The company notes that its plans and expectations are subject to risks and uncertainties, including the outcome of ongoing legal proceedings. These uncertainties are critical for investors to consider, as they may materially affect future results.

Conclusion

The Federal Circuit’s affirmation of Teva Pharmaceuticals’ right to market a generic Korlym® without infringing on Corcept’s patents is a potentially price-sensitive event. It directly threatens Corcept’s market exclusivity for its flagship drug and could materially impact future revenues and share value. Investors should remain vigilant for updates on Corcept’s legal strategy and the progress of its broader clinical pipeline, as these will be important determinants of the company’s future performance.

Disclaimer

This article is for informational purposes only and does not constitute investment advice. Investors are encouraged to review Corcept’s filings with the SEC and consult with their financial advisors regarding the risks and uncertainties discussed herein. The information provided reflects the company’s statements as of the date of the report and may be subject to change.

View CORCEPT THERAPEUTICS INC Historical chart here