Full Press Release Details
FENNEC ANNOUNCES ISSUANCE OF U.S. PATENT
FOR USE OF PEDMARKTM
Research Triangle Park, NC, March 5,
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 10,596,190 entitled "Method for Reducing Ototoxicity in Pediatric Patients Receiving Platinum-Based
Chemotherapy." As suggested by the title, the patent captures the use of Fennec's PEDMARK product to reduce the
ototoxic effects of cisplatin in pediatric patients, particularly in the age group of five years or younger. This is U.S
Food and Drug Administration (FDA) Orange Book eligible U.S. patent, 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 the U.S. Patent 10,596,190, strengthens the
position of PEDMARK as the potential first and only treatment for the prevention of platinum induced ototoxicity in pediatric patients.
About PEDMARK (Sodium Thiosulfate (STS))
Cisplatin and other platinum compounds
are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies can 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 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 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.
In February 2020, Fennec completed its
rolling submission of a New Drug Application (NDA) to the FDA for PEDMARK and submitted a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined). PEDMARK received
Breakthrough Therapy and Fast Track Designation by the FDA in March 2018. Further, PEDMARK has received Orphan Drug
Designation in the U.S. for this setting.
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. 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. 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 as 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, that regulatory and guideline developments may change, scientific
data 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, 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. Fennec Pharmaceuticals
Inc. 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:
Chief Executive Officer
Fennec Pharmaceuticals Inc.
Elixir Health Public Relations