Fennec Pharmaceuticals Announces Management Change
31 Janvier 2022 - 12:00PM
Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty
pharmaceutical company focused on the development of
PEDMARK™ (a unique formulation of sodium thiosulfate) for the
prevention of platinum-induced ototoxicity in pediatric patients,
today announced that Shubh Goel, the Company’s chief commercial
officer, has tendered her resignation and will depart Fennec in
late February.
“On behalf of the Board of Directors and
leadership team, we thank Shubh for her many contributions to the
Company. We continue to prepare for a commercial launch upon
approval,” said Rosty Raykov, chief executive officer
of Fennec Pharmaceuticals, Inc. “Fennec remains committed to
making PEDMARK™ available to children and young adults
receiving cisplatin chemotherapy, who currently have no approved
therapies for ototoxicity.”
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
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.
PEDMARK has received Breakthrough Therapy and
Fast Track Designation by the FDA in March 2018. The Marketing
Authorization Application (MAA) for sodium thiosulfate (tradename
PEDMARQSI) is currently under evaluation by the European
Medicines Agency (EMA).
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 and,
pending FDA approval, the Company’s planned commercial launch 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 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.(919) 246-5299
Media:Elixir Health Public RelationsLindsay
Rocco(862) 596-1304lrocco@elixirhealthpr.com
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