Full Press Release Details
PHARMACEUTICALS COMPLETES ROLLING SUBMISSION OF NEW DRUG APPLICATION (NDA) TO U.S. FOOD AND DRUG ADMINISTRATION FOR PEDMARKTM
AND ALSO SUBMITS MARKETING AUTHORIZATION APPLICATION
(MAA) TO EUROPEAN MEDICINES AGENCY
PEDMARKTM1 is Being Developed for Prevention
of Cisplatin-Induced Hearing Loss in Children
Research Triangle Park, NC, Feb. 11, 2020 -
Fennec Pharmaceuticals Inc. (Nasdaq:FENC; TSX: FRX), a specialty pharmaceutical company, today announced it has completed
its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for PEDMARKTM
(a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing
Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined).
The PEDMARKTM indication requested is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients
one month to < 18 years of age with localized, non-metastatic, solid tumors.
regulatory submissions follow: a pre-NDA meeting with the FDA in December 2018 after which
Fennec initiated a rolling NDA; and pre-submission meetings with the EMA and an approved pediatric investigation plan (PIP). Both
applications are based upon clinical results from two pivotal Phase 3 clinical trials:
dedicated to the development of PEDMARK for the prevention of ototoxicity in children. The completion of these regulatory submissions
to the FDA and EMA are the culmination of many years of hard work, bringing us one step closer to achieving our mission,"
said Rosty Raykov, chief executive officer of Fennec. "Fennec would like to thank the many parents, children and
investigators who participated in the clinical trials, as well as our dedicated employees who helped us reach this important milestone.
We are well underway with commercialization readiness activities to support the potential launch of PEDMARK and our transition
to becoming a commercial-stage organization."
PEDMARK is US proposed tradename. European tradename is under evaluation.
a 60-day review period to determine whether the PEDMARK NDA is acceptable for filing.
PEDMARK has been granted Orphan Drug, Breakthrough Therapy, and Fast Track designations from the FDA. If
PEDMARK is granted a priority review, the Prescription Drug User Fee Act (PDUFA) action date is expected in the third quarter of
About PEDMARK (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 is particularly harmful to the survivors of pediatric cancer.
In the U.S. and Europe, it is estimated annually that
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 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.
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.
PEDMARK received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.
Further, PEDMARK has received Orphan Drug Designation in the U.S. for this setting. 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 that regulatory and guideline developments
may change, scientific data or the Company's new drug applications may not be sufficient to meet regulatory standards or
receipt of required regulatory clearances or approvals, commercialization execution, 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 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, 2018. Fennec Pharmaceuticals, Inc. disclaims any
obligation to update these forward-looking statements except as required by law.
The scientific information discussed in this news release related
to PEDMARK is preliminary and investigative. Such product candidates are not approved by the FDA, EMA, Health Canada or
other regulatory bodies and no conclusions can or should be drawn regarding the safety or effectiveness of such product candidate.
For further information, please contact:
Chief Executive Officer
Fennec Pharmaceuticals Inc.
Elixir Health Public Relations