Fennec does not expect U.S. approval for hearing loss drug, shares slump

By CH News On Nov 29, 2021

Nov 29 (Reuters) – Fennec Pharmaceuticals Inc (FENC.O) said Monday it expects the U.S. health regulator to again reject the marketing application for its drug to prevent chemotherapy-induced hearing loss in children, causing its shares to tumble 45%.

The Food and Drug Administration (FDA) indicated deficiencies were identified after an inspection of the drug’s manufacturing facility, the company said, without providing further details.

This is the second potential setback for Pedmark, Fennec’s only clinical drug candidate in the pipeline. The FDA had refused to approve the drug last year for similar reasons.

The company resubmitted its application earlier this year, which the regulator accepted for review and set a target date of Nov. 27 to make its decision.

Pedmark, given intravenously, is intended for children between one month and 18 years of age who have received platinum-based chemotherapy, which uses a drug called cisplatin.

Such therapies are often used to treat a range of childhood cancers, but can cause permanent hearing loss, which can also affect survivors of childhood cancer.

In two late-stage studies, also under review by the European Medicines Agency, Pedmark showed that it reduced the incidence of cisplatin-induced hearing loss in children with cancers such as liver, bone and brain cancer.

Currently, there are no approved therapies for the prevention of cisplatin-induced hearing loss in children in the United States.

According to Fennec, more than 10,000 children in the United States and Europe may receive platinum-based chemotherapy each year.

Fennec said Monday it plans to meet with the FDA to discuss the deficiencies and steps to resubmit the marketing application once it receives an official decision.

The company’s shares were $5.30 in premarket trading, after gaining about 29% through Friday so far this year.

Reporting by Amruta Khandekar; Editing by Shounak Dasgupta and Sriraj Kalluvila

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