Full Press Release Details
FENNEC PHARMACEUTICALS ANNOUNCES FDA
FILING ACCEPTANCE AND PRIORITY REVIEW OF NEW DRUG APPLICATION FOR PEDMARKTM
~ Potential for PEDMARK to be the First
Product for the Prevention of Cisplatin-Induced Hearing Loss in Children ~
~ FDA Grants Priority Review and Sets
a Prescription Drug User Fee Act (PDUFA) Target Action Date of August 10, 2020 ~
Research Triangle Park, NC, April 13,
2020 - Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company, announced today
that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for the company's New
Drug Application (NDA) for PEDMARK (a unique formulation of sodium thiosulfate). PEDMARK is an investigational
drug for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localized,
non-metastatic, solid tumors.
FDA filing acceptance of our NDA and granting of Priority Review represents a significant milestone in the development of PEDMARK
and we look forward to working closely with the Agency during this review process,"
said Rosty Raykov, chief executive officer of Fennec.
FDA grants Priority Review to applications for medicines that treat a serious condition, and, if approved, would demonstrate the
potential to be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious
condition. Priority Review designation shortens the review period from the standard ten months to six months from the submission
of the NDA. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of August 10, 2020 for the completion
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
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 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 enrolled only hepatoblastoma patients with localized tumors.
The FDA has accepted for filing the Company's
New Drug Application (NDA) for PEDMARK and has granted Priority Review. The Marketing Authorization Application (MAA) for
sodium thiosulfate (tradename to be determined) is currently under evaluation by the European Medicines Agency (EMA).
PEDMARK has received Breakthrough Therapy and Fast Track Designation by 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. 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 STS and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy,
in humans. For more information, please visit www.fennecpharma.com
Forward Looking Statements
Except for historical information described
in this press release, all other statements are forward-looking. 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 as 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, that regulatory and guideline developments may change, scientific
data 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, 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 product will not be
as large as expected, the Company's product 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, 2019. Fennec Pharmaceuticals,
Inc. disclaims any obligation to update these forward-looking statements except as required by law.
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 Executive Officer
Fennec Pharmaceuticals Inc.
Elixir Health Public Relations