Amicus Therapeutics Announces Settlement of Galafold® (migalastat) Patent Litigation with Teva

Rhea-AI Summary

Amicus Therapeutics (Nasdaq: FOLD) has announced a settlement in the Galafold® (migalastat) patent litigation with Teva Pharmaceuticals. The key points of the agreement are:

1. Amicus grants Teva a license to market a generic version of Galafold® in the United States starting January 30, 2037, subject to FDA approval.

2. The ongoing Hatch-Waxman litigation between Amicus and Teva regarding Galafold® patents will be terminated.

3. Litigation continues against Aurobindo, while the stay remains in place for Lupin.

4. The confidential license agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

This settlement resolves the patent dispute initiated by Amicus in response to Teva's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Galafold® before the expiration of applicable patents.

Positive

• Settlement of patent litigation with Teva, reducing legal uncertainties
• Secured market exclusivity for Galafold® until January 2037
• Continuation of litigation against other generic challengers, potentially extending exclusivity

Negative

• Potential generic competition for Galafold® starting January 2037

Insights

Legal Expert

This settlement with Teva is a significant development for Amicus Therapeutics, effectively protecting their flagship product Galafold® from generic competition until 2037. The agreement grants Amicus over 12 years of additional market exclusivity beyond the drug's initial patent expiration. This extended period of exclusivity is important for rare disease treatments, where development costs are high and patient populations are small. The resolution of the patent litigation removes a major legal uncertainty for Amicus, potentially improving investor confidence. However, it's important to note that litigation continues with Aurobindo and the stay remains in place for Lupin, indicating ongoing challenges to Galafold's patent protection. The settlement terms, including any potential payments or royalties, remain confidential pending regulatory review, which could impact the overall financial implications of this agreement for Amicus.

Financial Analyst

This settlement is likely to have a positive impact on Amicus Therapeutics' long-term financial outlook. Galafold® is the company's lead product and securing market exclusivity until 2037 provides a clear revenue runway for over a decade. This stability in future cash flows could enhance the company's valuation and potentially improve its ability to raise capital for pipeline development. Investors should consider how this extended exclusivity period might affect Amicus' R&D strategy and potential for future growth. While the immediate financial terms of the settlement are not disclosed, the agreement likely avoids costly ongoing litigation expenses. However, it's important to monitor the remaining patent challenges and their potential impact on Galafold's market position. The stock may react positively to this news as it reduces uncertainty and extends the product lifecycle of a key revenue driver.

Company Grants Teva a License to Market Generic Galafold® Beginning in January 2037

PRINCETON, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that it has entered into a License Agreement (Agreement) with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). This Agreement resolves the patent litigation brought by Amicus in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of GALAFOLD^® (migalastat) 123mg capsules prior to expiration of the applicable patents.

Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD^® in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD^® patents pending in the U.S. District Court for the District of Delaware. The litigation will continue against Aurobindo¹ as the remaining active party and the litigation stay remains in place for Lupin².

As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on X and LinkedIn.

Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements concerning: the terms of the settlement agreement with Teva, expectations regarding the impact of the settlement agreement and submission of the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties, including the unfavorable outcome of other litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to GALAFOLD, which may lead to competition from generic drug manufacturers; the outcome of any review of the settlement agreement by the United States Federal Trade Commission and United States Department of Justice; the U.S. FDA may approve Teva's ANDA significantly in advance of the entry date; and those risks and uncertainties described under the heading "Risk Factors" in the company's most recent Annual Report on Form 10-K for the year ended December 31, 2023, and on Form 10-Q for the quarter ended June 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

CONTACT:

Investors:
Amicus Therapeutics
Andrew Faughnan
Vice President, Investor Relations
afaughnan@amicusrx.com
(609) 662-3809

Media:
Amicus Therapeutics
Diana Moore
Head of Global Corporate Affairs and Communications
dmoore@amicusrx.com
(609) 662-5079

FOLD–G

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¹ Aurobindo Pharma LTD and Aurobindo Pharma USA, Inc.
² Lupin LTD and Lupin Pharmaceuticals, Inc.

FAQ

When will Teva be allowed to market generic Galafold® according to the settlement with Amicus Therapeutics (FOLD)?

According to the settlement, Teva will be allowed to market its generic version of Galafold® in the United States beginning on January 30, 2037, subject to FDA approval.

What is the current status of Amicus Therapeutics' (FOLD) patent litigation for Galafold®?

Amicus has settled with Teva, terminating their litigation. The litigation continues against Aurobindo, while the stay remains in place for Lupin.

What regulatory review is required for the Amicus Therapeutics (FOLD) and Teva settlement agreement?

The confidential license agreement must be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, as required by law.

What prompted the patent litigation between Amicus Therapeutics (FOLD) and Teva regarding Galafold®?

The litigation was brought by Amicus in response to Teva's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Galafold® prior to the expiration of applicable patents.