Fennec Announces Issuance of U.S. Patent for PEDMARK™
September 21 2020 - 6:00AM
Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty
pharmaceutical company focused on the development of PEDMARKTM (a
unique formulation of sodium thiosulfate (STS)) for the prevention
of platinum-induced ototoxicity in pediatric patients, today
announced that the U.S. Patent and Trademark Office will issue U.S.
Patent 10,792,363 entitled “Anhydrous Sodium Thiosulfate and
Formulations Thereof.” As suggested by the title, the patent
captures the unique anhydrous form of the active ingredient in
Fennec’s PEDMARK product, as well as related methods of
synthesis. This patent is eligible for listing in the U.S
Food and Drug Administration (FDA) Orange Book, and reflects
Fennec’s strategy to expand and diversify its intellectual property
portfolio to obtain protection for the PEDMARK product.
PEDMARK was granted Orphan Drug Designation by
the FDA in 2004. This designation, along with a patent portfolio
that includes a previously issued method of use patent from March
2020 and this recent to-be-issued composition patent, further
strengthens the position of PEDMARK as the first potential
treatment for the prevention of platinum induced ototoxicity in
pediatric patients.
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 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 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.
PEDMARK 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).
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 (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. These
forward-looking statements include statements regarding the
Company’s strategy to expand and diversify its intellectual
property portfolio to obtain protection for the PEDMARK product.
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, 2019 and its Quarterly Report on Form 10-Q for the
quarter ended June 30, 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:
Investors:Rosty RaykovChief Executive
OfficerFennec Pharmaceuticals Inc.+1 919-636-5144
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