Full Press Release Details
FENNEC PHARMACEUTICALS ANNOUNCES MANAGEMENT
Research Triangle Park, NC, Jan. 31, 2022 - Fennec
Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a
unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced that
Shubh Goel, the Company's chief commercial officer, has tendered her resignation and will depart Fennec in late February.
"On behalf of the Board of Directors and
leadership team, we thank Shubh for her many contributions to the Company. We continue to prepare for a commercial launch upon approval,"
said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. "Fennec
remains committed to making PEDMARKTM available
to children and young adults receiving cisplatin chemotherapy, who currently have no approved therapies for ototoxicity."
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.
Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use. Fennec has a license agreement with Oregon
Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate
and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For more information,
please visit www.fennecpharma.com
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 particularly harmful to the survivors of pediatric cancer.
In the U.S. and Europe, it is estimated
that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose
and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent
for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide
some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and
literacy, and older children and adolescents lack social-emotional development and educational achievement.
PEDMARK has been studied by cooperative groups
in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6.
Both studies have been completed. The COG ACCL0431 protocol enrolled 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 enrolled only hepatoblastoma patients with localized tumors.
PEDMARK has received Breakthrough Therapy and
Fast Track Designation by the FDA in March 2018. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename
PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).
Forward Looking Statements
Except for 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 and, pending FDA approval, the Company's planned commercial launch of
PEDMARKTM.. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's
business that could cause actual results to vary, including such risks and uncertainties that regulatory and guideline developments may
change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory
clearances or approvals, clinical results may not be replicated in actual patient settings, Fennec's reliance on third party manufacturing,
unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such
as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company's
patents and patent applications may be challenged, invalidated or circumvented 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, revenues
will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different
countries and municipalities, and other risks detailed 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 update these forward-looking statements except
For a more detailed discussion of related
risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.
For further information, please contact:
Chief Financial Officer
Fennec Pharmaceuticals Inc.
Elixir Health Public Relations