Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food and Drug Administration for Pedmark™
24 Mars 2022 - 11:00AM
Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty
pharmaceutical company, today announced the resubmission of its New
Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for PEDMARK™ (a unique
formulation of sodium thiosulfate (STS)) for the prevention of
platinum-induced ototoxicity in pediatric patients one month to
<18 years of age with localized, non-metastatic, solid tumors.
“We appreciate the FDA’s comments during the
resubmission process and look forward to working closing with the
Agency during the NDA review,” said Rosty Raykov, chief executive
officer of Fennec Pharmaceuticals. “We are pleased to have reached
this important step and Fennec remains committed to making
PEDMARK™ available to reduce the risk of cisplatin induced
ototoxicity in pediatric patients.”
About PEDMARK™
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.
The Marketing Authorization Application (MAA)
for sodium thiosulfate (tradename PEDMARQSI) 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 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
resolution the issues raised in the CRL and the Company’s plans to
address them, and the anticipated timing of the Company’s
finalization and filing of an NDA resubmission for 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 such risks and uncertainties
relating to the Company’s reliance on third party manufacturing,
the risk that unforeseen factors may delay the resubmission of the
NDA, the risks of delays in or failure to obtain FDA approval of
PEDMARK, the risks relating to the Company’s and its manufacturer’s
ability to adequately address the concerns identified in the CRL,
the risk that the resubmission of the NDA 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, 2021. 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:
Investors:Robert AndradeChief Financial
OfficerFennec Pharmaceuticals Inc.(919) 246-5299
Media:Elixir Health Public RelationsLindsay
Rocco(862) 596-1304lrocco@elixirhealthpr.com
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