Fennec Pharmaceuticals Inc. (FRX) said on Monday it has reached an agreement with Cipla Limited and Cipla USA Inc. to settle litigation related to Cipla's application to the U.S. Food and Drug Administration to market a generic version of Fennec's Pedmark (sodium thiosulfate injection).
Fennec shares were up more than 6% in pre-market trading after closing at $7.52 on Friday.
Under the agreement, Cipla has agreed not to launch its generic sodium thiosulfate product until September 1, 2033, unless certain earlier-entry conditions are met. The lawsuit will be dismissed, with each party bearing its own costs.
Pedmark is the first FDA-approved therapy indicated to reduce the risk of ototoxicity—hearing damage—associated with cisplatin treatment in pediatric patients aged one month and older with localized, non-metastatic solid tumors.
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