Catalyst Pharmaceuticals Comments on FDA's Announcement of its Position on Orphan Drug Exclusivity In Light of the 11th Circuit Decision in Catalyst Pharmaceuticals, Inc. v. Becerra

Rhea-AI Summary

Catalyst Pharmaceuticals (NASDAQ: CPRX) announced today that it received notice from an ANDA filer regarding a generic version of FIRDAPSE®. Teva Pharmaceuticals seeks FDA authorization to manufacture and sell this generic drug. Catalyst noted that while the FDA complies with the 11th Circuit's decision favorable to the company regarding FIRDAPSE®, the agency will continue to enforce regulations on orphan drug exclusivity. Catalyst is not affected by this new FDA position and plans to vigorously protect its intellectual property rights related to FIRDAPSE®. The FDA approved Catalyst's application expanding FIRDAPSE® label for children aged 6-17 in September 2022.

Positive

• FDA approval of FIRDAPSE® label expansion for children aged 6-17 in September 2022.
• Catalyst plans to vigorously enforce its intellectual property rights against generic competition.

Negative

• Teva Pharmaceuticals filed an abbreviated new drug application challenging FIRDAPSE®.
• Potential revenue impact from a generic version of FIRDAPSE® entering the market.

Announced Earlier Today-Notice Received from ANDA Filer for FIRDAPSE®

CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today commented on the FDA's notice setting forth its position on Orphan Drug Exclusivity in light of the 11^th Circuit's decision in Catalyst Pharmaceuticals, Inc. v. Becerra. The FDA announcement states that while the FDA is complying with the 11^th Circuit decision in Catalyst's favor with respect to FIRDAPSE®, the FDA intends to continue to apply its regulations tying the scope of orphan drug exclusivity to the uses or indications for which a drug is approved with respect to other orphan drugs. Catalyst reports that it is not affected by the FDA's newly announced position and that the FDA's announcement confirms the FDA's previous decision to set aside the approval of RUZURGI® as a result of the 11^th Circuit's decision. Further, Catalyst acquired the United States rights to RUZURGI®, including all intellectual property relating thereto, in July 2022. Finally, Catalyst's supplemental New Drug Application expanding its label for FIRDAPSE® to children ages 6-17 was approved by the FDA in September 2022.

Separately, Catalyst announced this morning that an abbreviated new drug application has been filed by Teva Pharmaceuticals, Inc., seeking authorization from the FDA to manufacture, use, or sell a generic version of FIRDAPSE® in the United States. As Catalyst has previously reported, the filing of a Paragraph IV challenge to FIRDAPSE® was not unexpected, and Catalyst intends to vigorously enforce its intellectual property rights relating to FIRDAPSE®.

About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst's New Drug Application for FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration and FIRDAPSE is commercially available in the United States as a treatment for adults and children ages six to seventeen with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.

For more information, visit Catalyst's website at www.catalystpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including those set forth in Catalyst's Annual Report on Form 10-K for the fiscal year 2021, its Quarterly Report on Form 10-Q, and its other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

FAQ

What is the latest news about Catalyst Pharmaceuticals (CPRX)?

Catalyst Pharmaceuticals announced that Teva Pharmaceuticals has filed an ANDA for a generic version of FIRDAPSE®.

How did Catalyst Pharmaceuticals respond to Teva's filing for a generic FIRDAPSE®?

Catalyst intends to vigorously enforce its intellectual property rights regarding FIRDAPSE®.

What did the FDA announce regarding orphan drug exclusivity for Catalyst Pharmaceuticals?

The FDA confirmed it would apply regulations regarding orphan drug exclusivity while complying with the 11th Circuit's decision in Catalyst's favor.

When was the FIRDAPSE® label expanded for children by Catalyst Pharmaceuticals?

The FDA approved the label expansion for FIRDAPSE® to children aged 6-17 in September 2022.