Fennec Sues Cipla to Block Copies of Lone Drug, Pedmark Infusion

Fennec Pharmaceuticals Inc. alleges that a copy of Pedmark proposed by Cipla Ltd. infringes three patents for the infusion, used to treat hearing loss associated with chemotherapy in children with cancer, including one exclusively licensed from Oregon Health & Science University.

The US Food and Drug Administration approved Pedmark—Fennec’s only drug—on Sept. 20 to reduce the risk of ototoxicity associated with cisplatin chemotherapy in children ages 1 month and older with localized, non-metastatic solid tumors, according to a complaint filed Tuesday in the US District Court for the District of New Jersey.

Ototoxicity happens when a patient develops problems ...