Fennec Pharmaceuticals Expects to Receive 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

FDA Pre-Approval Inspection Identified Deficiencies at Drug Manufacturer’s Facility Requiring Remediation Prior to PEDMARK Approval

RESEARCH TRIANGLE PARK, NC, Nov. 29, 2021 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced today that it expects to receive a Complete Response Letter (CRL) after the PDUFA Target Action Date of November 27, 2021 of the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate), for intravenous administration to prevent ototoxicity associated with cisplatin chemotherapy in pediatric patients 1 month to 18 years with localized, non-metastatic, solid tumors.

The FDA has identified deficiencies following a recent completion of a pre-approval inspection at our drug manufacturer’s manufacturing facility. Once the official CRL is received, the company plans to request a Type A meeting to discuss the deficiencies and steps required to resubmit the NDA for PEDMARKTM.

About PEDMARK™ (a unique formulation of sodium thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and especially harmful to childhood cancer survivors.

In the US and Europe, it is estimated that more than 10,000 children may receive platinum-based chemotherapy each year. The incidence of ototoxicity depends on the dose and duration of chemotherapy, and many of these children require hearing aids for life. There is currently no proven preventative for this type of hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide any benefit. Infants and young children who suffer from ototoxicity at critical developmental stages lack speech-language development and literacy, and older children and adolescents lack socio-emotional development and educational achievement.

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PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies on survival and reduction of ototoxicity, the Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol registered one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 included only hepatoblastoma patients with localized tumors.

The Marketing Authorization (MAA) application for sodium thiosulfate (trade name PEDMARQSI) is currently under review by the European Medicines Agency (EMA). PEDMARK received the Breakthrough Therapy and Fast Track Designation from the FDA in March 2018.

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients. In addition, PEDMARK has received the Orphan Drug Designation in the US for this institution. Fennec has a licensing agreement with Oregon Health and Science University for exclusive worldwide licensing rights to intellectual property directed to STS and its use for chemoprotection, including the prevention of ototoxicity caused by platinum chemotherapy, in humans. For more information, visit www.fennecpharma.com.

Forward-Looking Statements

Except for the historical information described in this press release, all other statements are forward-looking. These forward-looking statements include the Company’s expectations regarding its interactions and communications with the FDA, including its expectation to discuss with the FDA the issues raised in the CRL and the Company’s plans to address them. to grab. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business and that could cause actual results to vary, including risks and uncertainties that could change developments in regulations and guidelines, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receive required regulatory approvals or approvals, clinical results may not be replicated in the actual patient environment, Fennec’s reliance on third-party manufacturing, unforeseen global instability, including political instability, or instability from an outbreak of a pandemic or contagious disease, such as the novel coronavirus (COVID-19), or around the duration and severity of an outbreak, the protections afforded by the company’s patents and patent applications can be challenged, invalidated or bypassed by its competitors, the available market for the company’s products will not be as large as expected, the company’s products will not be able to penetrate one or more targeted markets, the revenues will not be sufficient to fund further development and clinical studies, the company is unable to meet its future capital requirements in various states and municipalities, and other risks described from time to time in the company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2020 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Fennec disclaims any obligation to make these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please see our public filings available at www.sec.gov and www.sedar.com.

For more information, please contact:

Robert Andrade
Financial director
Fennec Pharmaceuticals Inc.
+1 919-246-5299

Business and media:
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304

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