Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors

~ No Clinical Safety or Efficacy Issues Identified, and No Requirement for Further Clinical Data ~

~ FDA Pre-Approval Inspection has Identified Deficiencies with the Facility of the Drug Product Manufacturer, which Require Resolution Prior to PEDMARK Approval ~

~ Company to Host Conference Call and Webcast Today, Tuesday, August 11, 2020, at 8:30 a.m. ET ~

RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARK (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥1 month to 18 years of age with localized, non-metastatic, solid tumors.

According to the CRL, after recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of conditions or practices that are required to be resolved prior to the approval of PEDMARK.  The Company plans to request a Type A meeting to discuss the issues and other matters that were described in the CRL pertaining to the steps required for the resubmission of the NDA for PEDMARK.  Importantly, no clinical safety or efficacy issues were identified during the review and there is no requirement for further clinical data.

“We are steadfast in our commitment to reducing the risk of life-long hearing loss for children receiving cisplatin chemotherapy who currently have no approved therapies for this devastating condition,” said Rosty Raykov, chief executive officer of Fennec. “We will work closely with our manufacturer and the FDA to fully address the issues raised in the letter as expeditiously as possible.”

The Company has existing cash, which totaled approximately $38.7 million as of June 30, 2020.

Conference Call and Webcast

Fennec will host a conference call and webcast on Tuesday, August 11, 2020, at 8:30 a.m. ET. The conference call can be accessed by dialing [phone] for domestic callers or [phone] for international callers. Please provide the operator with the conference ID 7791698 to join the conference call.