Catalyst Pharmaceuticals ( NASDAQ: CPRX ) said it settled a patent infringement litigation with Jacobus Pharmaceuticals and PantherRx Rare related to their marketing of Ruzurgi, a version of the Catalyst's autoimmune disorder therapy Firdapse.
Catalyst's Firdapse (amifampridine) is used to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder which causes miscommunication between the nerve cell and the muscles, leading to gradual onset of muscle weakness.
Under the settlement, Catalyst will dismiss all claims related to the lawsuit and has acquired certain of Jacobus' intellectual property rights, including the rights to develop and commercialize Ruzurgi in the U.S. and Mexico.
Catalyst added that it will make a cash payment to Jacobus plus pay Jacobus a low single digit royalty on Catalyst's U.S. net sales of amifampridine.
Catalyst noted that Ruzurgi is not currently approved for distribution in the U.S. as the FDA converted the Ruzurgi approval for pediatric use to a tentative approval after the U.S. Circuit Court of Appeals for the 11th Circuit declared that approval of Jacobus' application for Ruzurgi violated Catalyst's orphan drug exclusivity for Firdapse to treat LEMS.
Catalyst ( CPRX ) said that Jacobus also agreed to dismiss its pending petition in the U.S. Supreme Court seeking to overturn the Appeals Court's decision.
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Catalyst settles patent lawsuit for autoimmune disorder drug Firdapse with Jacobus