Fennec Announces Issuance of U.S. Patent for PEDMARK™

Rhea-AI Summary

Fennec Pharmaceuticals announced that the U.S. Patent and Trademark Office will issue U.S. Patent 10,792,363 covering anhydrous sodium thiosulfate formulations for its drug PEDMARK. This patent enhances the drug's intellectual property protection as Fennec aims to prevent platinum-induced ototoxicity in pediatric patients. PEDMARK, previously designated as an Orphan Drug, is pivotal for children undergoing platinum-based chemotherapy. The European Medicines Agency is currently evaluating its Marketing Authorization Application.

Positive

• Issuance of U.S. Patent 10,792,363 strengthens PEDMARK's intellectual property protection.
• PEDMARK's Orphan Drug Designation enhances market position for pediatric patients.
• Ongoing evaluation by the European Medicines Agency for marketing authorization.

Negative

• None.

RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK^TM (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 Raykov
Chief Executive Officer
Fennec Pharmaceuticals Inc.
+1 919-636-5144

FAQ

What is the significance of U.S. Patent 10,792,363 for Fennec Pharmaceuticals?

The patent provides Fennec Pharmaceuticals with enhanced intellectual property protection for its drug PEDMARK, focusing on anhydrous sodium thiosulfate formulations.

How does PEDMARK help pediatric patients?

PEDMARK is designed to prevent platinum-induced ototoxicity, a type of permanent hearing loss, in children undergoing chemotherapy.

What designation has PEDMARK received from the FDA?

PEDMARK has received the Orphan Drug Designation from the FDA, which supports its development for a rare condition.

Is there an ongoing application for PEDMARK in Europe?

Yes, Fennec Pharmaceuticals has submitted a Marketing Authorization Application for PEDMARK to the European Medicines Agency, which is currently under evaluation.

What are the expected market implications of the new patent for Fennec Pharmaceuticals?

The new patent may enhance Fennec's market position and protect against competition, potentially increasing shareholder value.