Fennec Pharmaceuticals Announces Commercial Launch of PEDMARQSI® In Germany

Rhea-AI Summary

Fennec Pharmaceuticals (NASDAQ: FENC) announced the commercial launch of PEDMARQSI in Germany through Norgine Pharmaceuticals. PEDMARQSI is the first and only approved therapy in the EU and UK for preventing hearing loss caused by cisplatin chemotherapy in pediatric cancer patients aged 1 month to <18 years with localized, non-metastatic solid tumors.

The launch follows a March 2024 exclusive licensing agreement with Norgine for Europe, Australia, and New Zealand. Fennec received $43 million upfront and could receive up to $230 million in additional milestone payments, plus double-digit tiered royalties starting in mid-teens and growing to mid-twenties.

Clinical trials demonstrated that PEDMARQSI reduced cisplatin-induced hearing loss by approximately 50% compared to cisplatin alone. The drug received European Commission marketing authorization in June 2023 under PUMA, with 10 years of data and market protection.

Positive

• Received $43 million upfront payment from Norgine licensing agreement
• Potential for additional $230 million in milestone payments
• Double-digit tiered royalties starting mid-teens to mid-twenties
• First-mover advantage as only approved therapy for cisplatin-induced hearing loss in EU/UK
• 10-year market protection under PUMA designation

Negative

• None.

Insights

Pharmaceutical Industry Analyst

The commercial launch of PEDMARQSI in Germany marks a pivotal moment for Fennec Pharmaceuticals, representing significant near-term and long-term value creation potential. The licensing agreement with Norgine includes an immediate $43 million cash injection, strengthening Fennec's balance sheet, while the potential for up to $230 million in additional milestones provides substantial future upside.

The double-digit tiered royalty structure, starting in mid-teens and escalating to mid-twenties, is particularly attractive and suggests strong confidence in the product's commercial potential. Germany, as Europe's largest pharmaceutical market, serves as an ideal launch country, potentially setting precedent for pricing and reimbursement negotiations in other EU markets.

The pediatric-use marketing authorization (PUMA) designation provides critical market protection until 2033, creating a significant barrier to entry for potential competitors. This exclusivity period, combined with being first-to-market in addressing cisplatin-induced ototoxicity, positions PEDMARQSI favorably for market penetration and sustained revenue generation.

The robust clinical data demonstrating a 50% reduction in hearing loss incidence provides compelling evidence for healthcare providers and payers, likely facilitating reimbursement discussions and adoption. This is particularly significant given the long-term impact of hearing loss on pediatric patients' quality of life and development.

Looking ahead, successful commercialization in Germany could accelerate launches in other key European markets, creating a domino effect for revenue generation. The partnership with Norgine, leveraging their established European commercial infrastructure, significantly de-risks the international expansion strategy while allowing Fennec to focus on the U.S. market.

~ 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 <18 Years of Age with Localized, Non-Metastatic Solid Tumors ~

~ Norgine Pharmaceuticals’ Launch of PEDMARQSI in Germany Accelerates Global Commercialization Strategy ~

~ Milestone Marks an Important Step in Achieving Fennec’s Mission of Expanding Access to PEDMARQSI to Cancer Patients Across the Globe at Risk of Hearing Loss ~

RESEARCH TRIANGLE PARK, N.C., Feb. 07, 2025 (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 commercially launched PEDMARQSI (sodium thiosulfate injection) in Germany.

In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI^® in Europe, Australia and New Zealand. Under the terms of the previously announced exclusive licensing agreement with Norgine, Fennec received approximately $43 million in an upfront payment and will receive up to approximately $230 million in additional commercial and regulatory milestone payments along with double-digit tiered royalties on net sales of PEDMARQSI starting in the mid-teens and growing to the mid-twenties.

“Until now, there have been no pharmacological interventions available to cancer patients in Germany to prevent ototoxicity, or permanent hearing loss, caused by treatment with cisplatin,” said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. “We congratulate Norgine on making PEDMARQSI^® available to patients and healthcare providers in Germany and look forward to future launches in other major European markets.”

The 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.

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 <18 years of age with localized, non-metastatic solid tumors. PEDMARQSI was granted marketing authorization by the European Commission in June 2023 under the paediatric-use marketing authorization (PUMA), which includes 8 years plus 2 years of data and market protection.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of 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.ⁱ

The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.ⁱⁱ Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.ⁱⁱⁱ

PEDMARK^® (sodium thiosulfate injection)
PEDMARK^® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. PEDMARK is also recommended for the Adolescent and Young Adult (AYA) population by the National Comprehensive Cancer Network^® as a preventative treatment option to reduce hearing loss associated with platinum-based chemotherapy in patients with localized, non-metastatic tumors. PEDMARK is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s 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. 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 achievement.

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.

Indications and Usage
PEDMARK^® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m².

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >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^®/PEDMARQSI^®, the market opportunity for and market impact of PEDMARK^®/ PEDMARQSI^®, its potential impact on patients and anticipated benefits associated with its use, future commercial and regulatory milestone and royalty payments from Norgine, 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^® PEDMARQSI^® and Fennec^® are registered trademarks of Fennec Pharmaceuticals Inc.

©2025 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
lrocco@elixirhealthpr.com

_______________________
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.

FAQ

What are the financial terms of FENC's licensing agreement with Norgine for PEDMARQSI?

Fennec received $43 million upfront and can earn up to $230 million in additional milestone payments, plus double-digit tiered royalties starting in mid-teens and growing to mid-twenties.

How effective is PEDMARQSI in preventing cisplatin-induced hearing loss?

Clinical trials showed PEDMARQSI reduced cisplatin-induced hearing loss by approximately 50% compared to cisplatin treatment alone.

What market protection does PEDMARQSI have in Europe?

PEDMARQSI received 10 years of data and market protection under the paediatric-use marketing authorization (PUMA) granted by the European Commission in June 2023.

What is the approved age range for PEDMARQSI treatment in Europe?

PEDMARQSI is approved for patients aged 1 month to less than 18 years with localized, non-metastatic solid tumors.