Norgine introduces PEDMARQSI in Germany for pediatric cancer care

RESEARCH TRIANGLE PARK, N.C. - Fennec Pharmaceuticals (NASDAQ:FENC) Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company with a market capitalization of $183 million, announced today that their partner, Norgine Pharmaceuticals Ltd., has launched PEDMARQSI (sodium thiosulfate injection) in Germany. This marks a significant advancement in the global commercialization of the first approved therapy in the EU and U.K. for the prevention of cisplatin-induced ototoxicity in pediatric cancer patients.

The commercial launch in Germany is part of an exclusive licensing agreement from March 2024, allowing Norgine to market PEDMARQSI in Europe, Australia, and New Zealand. Fennec received an upfront payment of approximately $43 million and is eligible for up to $230 million in additional payments, plus royalties on net sales. According to InvestingPro data, the company has demonstrated impressive revenue growth of 278% over the last twelve months, with an industry-leading gross profit margin of 93.5%.

PEDMARQSI addresses the absence of pharmacological prevention for hearing loss in cancer patients undergoing cisplatin chemotherapy. Jeff Hackman, CEO of Fennec, expressed confidence in Norgine’s ability to provide this treatment to patients and healthcare providers in Germany and anticipates further European market introductions.

Clinical trials, including two open-label, randomized Phase 3 studies, demonstrated that PEDMARQSI could reduce the incidence of hearing loss by about 50% compared to cisplatin alone. The European Commission granted marketing authorization for PEDMARQSI in June 2023 under the paediatric-use marketing authorization (PUMA), securing data and market protection for ten years.

Cisplatin, a key chemotherapy drug, is associated with permanent and irreversible ototoxicity, significantly impacting pediatric cancer survivors’ quality of life. PEDMARQSI’s availability is expected to improve the standard of care for these patients.

PEDMARQSI is also FDA approved in the U.S. under the name PEDMARK and recommended by the National Comprehensive Cancer Network for pediatric patients with localized, non-metastatic solid tumors. The drug’s safety and efficacy have been established in two major clinical studies, COG ACCL0431 and SIOPEL 6.

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In other recent news, Fennec Pharmaceuticals has been making significant strides in its developments. The company’s partner, Norgine Pharmaceuticals Ltd., received final draft guidance from the National Institute for Health and Care Excellence endorsing PEDMARQSI for preventing cisplatin-induced hearing loss in young cancer patients. Clinical evidence from two Phase 3 trials showed that PEDMARQSI could reduce the risk of hearing loss by about 50% in children treated with cisplatin. This approval is a significant development as there have been no prior pharmacological interventions to prevent such ototoxicity.

On the financial front, Fennec reported robust growth in its third-quarter earnings. The company saw a rise in net product sales to $22 million for the first nine months of 2024, surpassing the total sales of 2023. Fennec also reported an increase in third-quarter net sales and a strong cash position, projecting the ability to fund operations well into 2026. Despite these positive outcomes, the treatment does carry risks, including hypersensitivity reactions and electrolyte imbalances, necessitating monitoring and management of patients. These are some of the recent developments in Fennec Pharmaceuticals.

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