Full Press Release Details
FENNEC PHARMACEUTICALS ANNOUNCES FDA ACCEPTANCE
OF NEW DRUG APPLICATION RESUBMISSION FOR PEDMARKTM
~ Prescription Drug User Fee Act (PDUFA) Target
Action Date Set for November 27, 2021 ~
~ NDA Resubmission for
PEDMARK for the Prevention of Cisplatin-Induced Ototoxicity for Pediatric Patients with Localized, Non-Metastatic Solid Tumors ~
~ If Approved by the FDA, PEDMARK Stands to
Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~
Research Triangle Park, NC, June 22, 2021
- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced that the U.S.
Food and Drug Administration (FDA) has accepted for
filing the resubmission of its New Drug Application (NDA) for PEDMARKTM
(a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month
to < 18 years of age with localized, non-metastatic, solid tumors. The Prescription Drug User Fee Act (PDUFA) target action date has
been set for November 27, 2021.
are pleased that the FDA has accepted our PEDMARKTM resubmission," said Rosty
Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. "We look forward to working closely with the FDA through the
review process. We are committed to bringing this treatment to children receiving cisplatin chemotherapy, an area of high unmet medical
need. If approved, PEDMARKTM stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity
in pediatric patients."
has been granted both Fast Track Designation and Breakthrough Therapy Designation by the FDA. The Complete Response Letter (CRL) received
on August 10, 2020, referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues
were identified and there was no requirement for further clinical data.
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 co-operative 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, medulloblastoma,
and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
The Marketing Authorization Application (MAA)
for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK received
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.
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
Forward Looking Statements
Except for historical information described
in this press release, all other statements are forward-looking. Words such as "believe," "anticipate," "plan,"
"expect," "estimate," "intend," "may," "will," or the negative of those terms,
and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the Company's
expectations regarding its interactions and communications with the FDA, including the Company's expectations and goals respecting
the NDA resubmission for PEDMARKTM. Obtaining Fast Track Designation and Breakthrough Therapy Designation by the FDA is no
guarantee that the FDA will approve the NDA resubmission of PEDMARK. Forward-looking statements are subject to certain risks and uncertainties
inherent in the Company's business that could cause actual results to vary, including the risk that unforeseen factors may result
in delays in or failure to obtain FDA approval of PEDMARK, the risks and uncertainties relating to the Company's reliance on third
party manufacturing, the risks that the Company's NDA resubmission does not adequately address the concerns identified in the CRL
previously provided by the FDA, the risk that the NDA resubmission to the FDA will not be satisfactory, 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, 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. Fennec 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 Financial Officer
Fennec Pharmaceuticals Inc.
Elixir Health Public Relations