Full Press Release Details
FENNEC ANNOUNCES ISSUANCE OF U.S. PATENT
Research Triangle Park, NC, September
21, 2020 - 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.
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
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
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.
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,
Chief Executive Officer
Fennec Pharmaceuticals Inc.