Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
30 Novembre 2021 - 12:00PM
Fennec Pharmaceuticals Inc., a specialty pharmaceutical company,
today announced that it received a Complete Response Letter (CRL)
on November 29, 2021 from the U.S. Food and Drug
Administration (FDA), after the PDUFA target action date of
November 27, 2021, regarding its New Drug Application (NDA) for
PEDMARK™ (a unique formulation of sodium thiosulfate), for
intravenous administration for the prevention of ototoxicity
associated with cisplatin chemotherapy in pediatric patients ≥ 1
month to 18 years of age with localized, non-metastatic, solid
tumors.
The CRL was issued as a result of identified
manufacturing deficiencies which need to be satisfactorily resolved
before the Pedmark NDA can be approved. Fennec plans to request a
Type A meeting with the FDA to discuss these deficiencies and other
matters described in the CRL, as well as the steps required for the
resubmission of the NDA for PEDMARK™.
“We are steadfast in our commitment to reducing
the risk of life-long hearing loss for children and young adults
receiving cisplatin chemotherapy who currently have no approved
therapies for this devastating condition,” said Rosty Raykov,
chief executive officer of Fennec Pharmaceuticals. “We will work
closely with our current manufacturer as well as the FDA to fully
address the issues raised in the letter. In addition, we continue
to advance our second drug product manufacturing facility.”
As of September 30, 2021, Fennec has existing
cash and cash equivalents, which totaled approximately $24
million.
About PEDMARK™ (A unique formulation of 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 that, annually, more than 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 type of 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.
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 setting.
Fennec has a license agreement with Oregon Health and Science
University 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. These
forward-looking statements include the Company’s expectations
regarding its interactions and communications with the FDA,
including its expectation to discuss with the FDA the issues raised
in the CRL and the Company’s plans to address them. 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 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.+1
919-246-5299randrade@fennecpharma.com
Corporate and Media:Elixir Health Public
RelationsLindsay Rocco+1 862-596-1304lrocco@elixirhealthpr.com
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