FOLD Stock Rises on Settling Galafold Patent Dispute With Teva
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Amicus Therapeutics FOLD announced that it has signed a licensing agreement with Teva Pharmaceuticals TEVA, which resolves the patent lawsuit filed earlier by FOLD. The litigation arose after Teva submitted an abbreviated new drug application seeking approval to sell a generic version of Amicus' Galafold (migalastat) 123 mg capsules before the related patents expired. The stock jumped 14% on Thursday as investors cheered the dispute settlement with TEVA.
Galafold, Amicus’ lead marketed drug, is the first and only approved oral medicine for patients living with Fabry disease, having amenable genetic variants.
Under the terms of the agreement, Amicus will grant Teva a license to sell its generic version of Galafold in the United States starting Jan. 30, 2037, pending FDA approval and subject to the fulfillment of certain customary conditions. The agreement ends all ongoing litigation between Amicus and Teva concerning Galafold patents in the U.S. District Court for Delaware. However, the litigation will continue against Aurobindo Pharma as the remaining active party, and the litigation stay remains in place for Lupin.
The companies will submit the confidential license agreement for review by the U.S. Federal Trade Commission and the Department of Justice, as required by law. Amicus’ shares jumped 14% on Thursday as investors cheered the dispute settlement with TEVA.
Year to date, shares of FOLD have plunged 15.6% compared with the industry’s 1.3% decline.
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Galafold – A Key Growth Driver for Amicus
Galafold has shown solid uptake since launch driven by continued demand. The sales of the drug have been rising consistently year over year. In the first six months of 2024, the drug generated sales worth $210.2 million, which increased 17% year over year at a constant currency basis. Galafold is currently approved in several countries, including the United States, EU, United Kingdom and Japan.
Owing to continued global uptake and sustained patient demand, FOLD increased Galafold's revenue guidance for 2024 in the second-quarter earnings release. The company now anticipates its total Galafold revenues to grow in the range of 14-18% compared with the previous guidance of 13-17%. The drug also has a strong intellectual property portfolio in the United States, providing patent protection through 2038. Label expansion, along with approvals in additional geographies, is likely to drive sales of the drug further in the days ahead.
Pompe Disease Drug – An Incremental Source of Revenues
Amicus also has a second FDA-approved drug in its commercial portfolio. In September 2023, the FDA approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) 65mg capsules, a two-component therapy for treating late-onset Pompe disease (LOPD) in adults who weigh more than 40 kg and are not improving on their current enzyme replacement therapy.