Fennec Pharmaceuticals Announces Pedmarqsi® Positive Recommendation by NICE for the Prevention of Cisplatin-Induced Hearing Loss in England and Wales

About this update from Fennec Pharmaceuticals Inc.

~ PEDMARQSI® (anhydrous sodium thiosulfate) is the first and only treatment available within NHS England and Wales for the prevention of cisplatin-induced ototoxicity (hearing loss) in children and young people (1 month-17 years of age) ~ ~ Data from two open-label, randomized Phase 3 trials, SIOPEL 6 (pivotal) and the Clinical Oncology Group (COG) Protocol ACCL0431, demonstrated an approximate 50% reduction in the occurrence of cisplatin-induced ototoxicity in patients treated with cisplatin and sodium thiosulfate vs. those treated with cisplatin alone ~ ~ There is a clear unmet need for the prevention of hearing loss caused by cisplatin and until now, there have been no preventative pharmacological interventions available, despite the significant lifelong impact hearing loss has on cancer patients ~ RESEARCH TRIANGLE PARK, N.C. , Dec. 20, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced that Norgine Pharmaceuticals Ltd. , a leading European specialist pharmaceutical company, has received positive final draft guidance from National Institute for Health and Care Excellence (NICE) recommending PEDMARQSI for the prevention of cisplatin-induced hearing loss in patients (aged 1 month to 17 years) with localized, non-metastatic, solid tumors. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity, or hearing loss, induced by cisplatin chemotherapy in patients 1 month to 5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia. Please see full Prescribing Information for PEDMARK® at: www.PEDMARK.com . About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and U.K. approval in October 2023 under the brand name PEDMARQSI. PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. 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. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK ® , the market opportunity for and market impact of PEDMARK ® , its potential impact on patients and anticipated benefits associated with its use, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the 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, 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, our ability to obtain necessary capital when needed on acceptable terms or at all, 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, 2023 . 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 . PEDMARK® and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc. ©2024 Fennec Pharmaceuticals Inc. All rights reserved. FEN-1604-v1 For further information, please contact: Investors: Robert Andrade Chief Financial Officer Fennec Pharmaceuticals Inc. +1 919-246-5299 Corporate and Media: Lindsay Rocco Elixir Health Public Relations+1 862-596-1304 [email protected] i Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369.ii Landier W. Ototoxicity and Cancer Therapy. Cancer . June 2016 Vol. 122, No.11: 1647-1658.iii Bass JK, Knight KR, Yock TI, et al. Evaluation and Management of Hearing Loss in Survivors of Childhood and Adolescent Cancers: A Report from the Children's Oncology Group . Pediatric Blood & Cancer . 2016 Jul;63(7):1152-1162. Source: Fennec Pharmaceuticals Inc.

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