About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. operates as a commercial-stage biopharmaceutical company. The company focuses on its only product candidate PEDMARK. On September 20, 2022, the company received approval from the United Stated Food and Drug Administration (FDA) for PEDMARK (sodium thiosulfate injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors. This approval makes PEDMARK the first and only treatment approved by the FDA in this area of significant unmet medical need. On October 17, 2022, the company announced commercial availability of PEDMARK in the United States. The company sells its product through an experienced field force, including Regional Pediatric Oncology Specialists and medical science liaisons who are helping to educate the medical communities and patients about cisplatin induced ototoxicity and its programs supporting patient access to PEDMARK. Further, the company has established Fennec HEARS, a comprehensive single source program designed to connect PEDMARK patients to both patient financial and product access support. The program offers assistance and resources, regardless of insurance type, that can address co-pays or lack of coverage when certain eligibility requirements are met. Fennec HEARS also provides access to care coordinators that can answer insurance questions about coverage for PEDMARK and provide tips and resources for managing treatment. The company received Orphan Drug Exclusivity for PEMARK in January 2023, which provides seven years of market exclusivity from its FDA approval on September 20, 2022, until September 20, 2029. The company has three patents listed for PEDMARK in the FDA’s Orange Book. In March 2020, the United States Patent and Trademark Office, or USPTO, allowed Patent No. 10,596,190 (US 190), which is exclusively in-licensed from Oregon Health & Science University (OHSU) and relates to a method of using its PEDMARK product. In September 2022, the USPTO issued Patent No. 11,291,728 (728) and in December 2022, the USPTO issued Patent No. 11,510,984 (984) that covers PEDMARK pharmaceutical formulation. The 728 and 984 patents will expire in 2039 and the 190 patent will expire in 2038. Additionally, in January 2023, the USPTO issued Notices of Allowance for an additional patent application that covers the PEDMARK pharmaceutical formulation. The company expects this additional U.S. patent to issue in Q1 or Q2 of 2023. This patent will expire in 2039, unless held invalid or unenforceable by a court of final jurisdiction. The company is also pursuing additional patent applications in both the U.S. and internationally for PEDMARK. PEDMARK Product Overview PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6. In the U.S. and Europe, it is estimated that, annually, more than 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. PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG 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, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. In August 2018, the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) accepted the company’s pediatric investigation plan (PIP) for sodium thiosulfate with the trade name Pedmarqsi for the condition of the prevention of platinum-induced hearing loss. In February 2020, the company announced that it had submitted a MAA for the prevention of ototoxicity induced by cisplatin chemotherapy patients 1 month to < 18 years of age with localized, non-metastatic, solid tumors. The EMA continues its review of the company’s MAA. Intellectual Property Patent Coverage The company’s patent portfolio reflects its strategy to expand and diversify its intellectual property to obtain protection for its PEDMARK product. The company’s wholly own two patent families directed to formulations that cover PEDMARK and other potential future sodium thiosulfate formulations, and methods of using and manufacturing the same. The company’s 363 issued patent covers a process of manufacture, which is a patent category that does not qualify for FDA orange book listing. One additional US pending patent application covering the company’s PEDMARK formulation has been allowed (US App. No. 17/871,825), and on issuance will be listed in the FDA Orange Book. Six additional US patent applications are pending, three of which applications cover methods of using its PEDMARK formulation and are eligible for listing on the FDA Orange Book if issued. The three other applications cover additional sodium thiosulfate formulations for potential future use. Additional applications from these families are pending in Australia, Brazil, Canada, China, the European Patent Office (EPO), Hong Kong, Indonesia, Israel, Japan, South Korea, Mexico, Malaysia, New Zealand, Russia, Singapore, and Thailand. Applications from these patent families, where granted, valid, and enforceable, will expire in July 2039, exclusive of any patent term adjustment or extension. The company has exclusively in-licensed from Oregon Health & Science University (OHSU) one patent family directed to the use of sodium thiosulfate to reduce the occurrence of ototoxicity. This family includes the granted US ‘190 Patent and one pending US patent application. The US ‘190 Patent has been listed in the FDA Orange Book. The US ‘190 Patent will expire in January 2038, unless held invalid or unenforceable by a court of final jurisdiction. The pending US patent application, if granted, valid, and enforceable, will expire in November 2037, exclusive of any patent term adjustment or extension. In 2022, OHSU abandoned applications from this family in all ex-US jurisdictions. FDA Orange Book Listings On April 5, 2022, the USPTO issued U.S. Patent No. 11,291,728 (the US ‘728 Patent) that covers the PEDMARK pharmaceutical formulation. On November 9, 2022, the USPTO issued U.S. Patent No. 11,510,984 (the US ‘984 Patent) that also covers the PEDMARK pharmaceutical formulation. On January 23, 2023, the USPTO issued a Notice of Allowance for an additional patent application (US App. No. 17/871,825) that covers the PEDMARK pharmaceutical formulation. The company owns three additional pending US patent applications directed to methods of treatment using the PEDMARK formulation. These patents where granted will expire in July 2039, exclusive of patent term adjustment and/or extension, unless held invalid or unenforceable by a court of final jurisdiction. The company has exclusively licensed from OHSU U.S. Patent No. 10,596,190 (the US ‘190 Patent) and a pending US patent application directed to a method of reducing ototoxicity using sodium thiosulfate. The US ‘190 Patent will expire in January 2038, unless held invalid or unenforceable by a court of final jurisdiction. The pending US patent application, if granted, valid, and enforceable, will expire in November 2037, exclusive of any patent term adjustment or extension, unless held invalid or unenforceable by a court of final jurisdiction. On approval of PEDMARK, the company listed the US ‘190 Patent and US ‘728 Patent in the United Stated Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The US’984 Patent was listed in the FDA Orange Book on December 14, 2022, following its issuance. A third formulation application, USSN 17/871,825 has been allowed by the U.S. Patent Office and will be listed when issued. If issued, the three additional US pending patent applications owned by the company and the exclusively licensed pending US patent application owned by OHSU are eligible for listing in the FDA Orange Book. Orphan Drug Exclusivity The company was granted Orphan Drug Exclusivity (ODE) in January 2023 for the use of PEDMARK in the indication to reduce the risk of ototoxicity, or hearing loss, associated with cisplatin use in pediatric patients one month of age and older with localized, non-metastatic solid tumors. The ODE designation is effective as of September 20, 2022, and provides the company with seven years of market exclusivity in the PEDMARK indication pursuant to Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360cc). The company plans to pursue PUMA upon approval of the MAA, which would allow for 10 years of market exclusivity upon PUMA approval. On February 20, 2013, the company entered into a new exclusive license agreement with OHSU for exclusive worldwide license rights to intellectual property directed to thiol-based compounds, including PEDMARK, and their use in oncology (the OHSU Agreement). OHSU will receive certain milestone payments, royalty on net sales for licensed products and a royalty on any consideration received from sublicensing of the licensed technology. On May 18, 2015, the company negotiated an amendment (Amendment 1) to the OHSU Agreement, which expands its exclusive license to include the use of N-acetylcysteine as a standalone therapy and/or in combination with STS for the prevention of ototoxicity induced by chemotherapeutic agents to treat cancers. Research and Development The company’s research and development expenses totaled $3.5 million for the fiscal year ended December 31, 2022. Government Regulation In addition to regulation by the FDA and certain state regulatory agencies, the company is subject to a variety of foreign regulations governing clinical trials and the marketing of other products. History The company was founded in 1996. It was incorporated under the Canada Business Corporations Act in 1996. It was formerly known as Adherex Technologies Inc. and changed its name to Fennec Pharmaceuticals Inc. in 2014.