Fennec Pharmaceuticals (FENC) delays Cipla generic PEDMARK rival until 2033
Rhea-AI Filing Summary
Fennec Pharmaceuticals Inc. reported that it has entered into a License Agreement with Cipla Limited and Cipla USA, Inc. to settle litigation over Cipla’s bid to market a generic version of Fennec’s PEDMARK® sodium thiosulfate injection. The lawsuit will be dismissed, with each party bearing its own costs. Cipla has agreed not to enter the U.S. market with its generic sodium thiosulfate product until September 1, 2033, subject to earlier entry under specified circumstances. PEDMARK, Fennec’s FDA-approved therapy to reduce the risk of cisplatin-induced hearing loss in certain pediatric cancer patients, remains the only approved product of its kind and is protected by orphan drug exclusivity and patents the company states extend to 2039.
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Insights
Settlement delays generic competition for PEDMARK, reinforcing Fennec’s exclusivity window.
Fennec Pharmaceuticals and Cipla have settled their dispute over a proposed generic to PEDMARK. The agreement ends the litigation, with dismissal of the lawsuit and each side paying its own legal costs, removing near-term courtroom uncertainty.
Crucially, Cipla agreed not to launch its generic sodium thiosulfate product in the U.S. before
The timing of any earlier entry is governed by conditions not detailed in the excerpt, so the actual competitive landscape will depend on future events. Subsequent company filings and updates will clarify how this settlement interacts with PEDMARK and PEDMARQSI commercialization in the U.S. and internationally.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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Current Report
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Item 8.01. | Other Events |
On March 16, 2026, Fennec Pharmaceuticals Inc. (the “Company”) entered into a License Agreement with Cipla Limited and Cipla USA, Inc. (together, “Cipla”) to resolve the litigation between the Company and Cipla relating to Cipla’s application to the U.S. Food and Drug Administration to market a generic version of the Company’s PEDMARK® (sodium thiosulfate injection) product, captioned Fennec Pharmaceuticals Inc. v. Cipla Limited and Cipla USA, Inc., C.A. No. 2:23-cv-00123-JKS-MAH (D.N.J.). Pursuant to the terms of the License Agreement, the lawsuit will be dismissed, each party will bear its own costs in connection with the litigation, and Cipla has agreed not to enter the U.S. market with its generic sodium thiosulfate product until September 1, 2033, subject to earlier entry under specified circumstances.
On March 16, 2026, the Company issued a press release announcing the License Agreement and resolution of the Cipla litigation a copy of which is furnished herewith as Exhibit 99.1.
The information contained in this Item 8.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor incorporated by reference into any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 9.01 | Financial Statements and Exhibits. |
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Exhibit 99.1 | Press Release dated March 16, 2026 |
Exhibit 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date March 16, 2026 | By: | /s/ Robert Andrade |
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| Robert Andrade Chief Financial Officer |
Exhibit 99.1
FENNEC PHARMACEUTICALS ANNOUNCES SETTLEMENT AGREEMENT RESOLVING PEDMARK PATENT LITIGATION
Research Triangle Park, NC, March 16, 2026 – Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announces that it has entered into an agreement with Cipla Limited and Cipla USA, Inc. to settle the litigation between them regarding Cipla’s application to FDA for approval to market a generic version of Fennec’s PEDMARK® (sodium thiosulfate injection) product. See Fennec Pharmaceuticals Inc. v. Cipla Limited and Cipla USA, Inc., C.A. No. 2:23-cv-00123-JKS-MAH (D.N.J.). Under the terms of the agreement, the lawsuit will be dismissed with each party bearing their own costs, and Cipla will not enter the market with its generic sodium thiosulfate product until September 1, 2033, or earlier under certain circumstances.
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 1 month of age and older 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 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.
Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.
Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.i,ii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.iii,iv
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 committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSIÒ.
In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in the U.K. and Germany.
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. Further, Fennec has patents providing protection for PEDMARK until 2039 in both the U.S. and internationally.
For more information, please visit www.fennecpharma.com and follow on LinkedIn.
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, 2024. 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.
©2026 Fennec Pharmaceuticals Inc. All rights reserved.
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 Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
ii Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63-74.
iii Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer. Int J Pediatr Otorhinolaryngol. 2020;138:110401. doi:10.1016/j.ijporl.2020.110401
iv Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.
FAQ
What did Fennec Pharmaceuticals (FENC) announce regarding its PEDMARK patent litigation with Cipla?
Fennec Pharmaceuticals announced a settlement and license agreement with Cipla resolving litigation over a proposed generic to PEDMARK. The lawsuit will be dismissed, each party will bear its own costs, and Cipla accepts restrictions on U.S. market entry for its generic sodium thiosulfate product.
When can Cipla launch a generic sodium thiosulfate product under its agreement with Fennec (FENC)?
Under the agreement, Cipla will not enter the U.S. market with its generic sodium thiosulfate product until September 1, 2033, or earlier under certain specified circumstances. This grants PEDMARK a defined period without Cipla’s generic competition in the U.S. market.
What is PEDMARK and how is it used in Fennec Pharmaceuticals’ (FENC) business?
PEDMARK is an FDA-approved sodium thiosulfate injection that reduces the risk of cisplatin-induced ototoxicity in certain pediatric cancer patients. It is Fennec’s core commercial product and the first and only approved therapy in the U.S. for this specific hearing-loss prevention indication.
What key safety concerns are highlighted for PEDMARK in Fennec Pharmaceuticals’ (FENC) disclosure?
The disclosure notes hypersensitivity reactions, hypernatremia, and hypokalemia as important safety issues with PEDMARK. It emphasizes contraindication in patients with severe hypersensitivity to sodium thiosulfate, monitoring electrolytes, and avoiding use in pediatric patients under one month of age or with metastatic cancers.
How long does Fennec Pharmaceuticals (FENC) expect protection for PEDMARK and PEDMARQSI to last?
Fennec states that PEDMARK has U.S. Orphan Drug Exclusivity and PEDMARQSI has European Pediatric Use Marketing Authorization, providing data and market protection. The company also reports patents supporting protection for PEDMARK until 2039 in the U.S. and internationally, reinforcing long-term exclusivity.
Where is Fennec Pharmaceuticals (FENC) commercializing PEDMARK and PEDMARQSI outside the United States?
Fennec has an exclusive licensing agreement with Norgine Pharmaceuticals to commercialize PEDMARQSI in Europe, the U.K., Australia, and New Zealand. PEDMARQSI is already commercially available in the U.K. and Germany, expanding access beyond the company’s U.S. PEDMARK franchise.
Filing Exhibits & Attachments
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