PRINCETON, N.J. - Amicus (NASDAQ:FOLD) Therapeutics (NASDAQ:FOLD) reached a settlement with Teva Pharmaceuticals, ending a patent litigation over the drug GALAFOLD. Under the agreement, Teva will be allowed to market a generic version of the rare disease treatment in the United States starting January 30, 2037, pending U.S. Food and Drug Administration approval.
The litigation initiated by Amicus was in response to Teva's attempt to introduce a generic form of GALAFOLD (migalastat) 123mg capsules before the patents expired. With this settlement, ongoing litigation under the Hatch-Waxman Act will be terminated, though Amicus continues its legal battle against Aurobindo Pharma and maintains a litigation stay with Lupin Pharmaceuticals.
The confidential terms of the license agreement will be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice as required by law.
Amicus Therapeutics , a global biotech company, is dedicated to developing treatments for rare diseases. The resolution with Teva is part of Amicus's broader strategy to protect its product portfolio and maintain its commitment to patients with rare diseases.
The announcement today is based on a press release statement, and it is important to note that the FDA's approval of Teva's generic version of GALAFOLD is not guaranteed and is subject to the regulatory body's standard review process. The specific financial details of the agreement have not been disclosed.
In other recent news, Amicus Therapeutics has reached a settlement with Teva Pharmaceuticals over a patent lawsuit related to the drug Galafold. This agreement allows Teva to sell a generic version of Galafold in the United States beginning January 30, 2037, or potentially earlier under certain conditions. Meanwhile, the ongoing patent litigation against Aurobindo continues, and the stay is still in effect for Lupin.
The biotechnology company has also reported a significant 34% growth in revenue, reaching $127 million in the second quarter of 2024. This increase was primarily driven by the strong performance of Galafold, which experienced a 19% surge in global sales. As a result, Amicus Therapeutics has raised its full-year revenue guidance to between 26-31%.
In addition, Jefferies, a global investment banking firm, initiated coverage of Amicus Therapeutics, setting a Buy rating on the stock. The firm anticipates that the company could engage in business development for a commercial rare disease drug within the next 12 to 18 months, a move projected to positively contribute to the company's earnings per share and drive margin expansion. These recent developments underline Amicus Therapeutics' potential for growth and expansion in the rare disease market.
InvestingPro Insights
Amicus Therapeutics' settlement with Teva Pharmaceuticals over GALAFOLD patent litigation provides a clearer picture of the company's future revenue stream. This development aligns with several key financial metrics and insights from InvestingPro.
According to InvestingPro data, Amicus Therapeutics has shown strong revenue growth, with a 29.98% increase over the last twelve months as of Q2 2024, reaching $455.65 million. This growth trajectory is further supported by an impressive 89.88% gross profit margin, indicating efficient cost management in producing GALAFOLD and other treatments.
InvestingPro Tips highlight that Amicus operates with a moderate level of debt and has liquid assets exceeding short-term obligations. These factors suggest financial stability, which is crucial for a biotech company investing heavily in research and development.
While the company is not currently profitable, with a negative P/E ratio of -30.94, InvestingPro Tips reveal that analysts expect Amicus to become profitable this year. This projection, combined with the patent settlement, could positively impact the company's financial outlook.
The market seems to be pricing in future growth potential, as evidenced by the high Price / Book multiple of 23.5. This valuation suggests investor confidence in Amicus's pipeline and market position in rare disease treatments.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. Currently, there are 8 more InvestingPro Tips available for Amicus Therapeutics, providing a deeper understanding of the company's financial health and market position.
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