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Fennec Pharmaceuticals Announces PEDMARK® (sodium thiosulfate injection) Receives Orphan Drug Exclusivity from U.S. FDA~ PEDMARK® is the First and Only FDA-Approved Therapy Indicated to Reduce the Risk of Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic Solid Tumors ~ ~ Orphan Drug Exclusivity Provides Seven Years of Market Exclusivity for PEDMARK® from its FDA Approval on September 20, 2022 Until September 20, 2029 ~ ~ Additionally, the Company Has Three FDA Orange Book Listings Providing U.S. Patent Protection for PEDMARK® Until 2039 ~ RESEARCH TRIANGLE PARK, N.C., Jan. 31, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity to PEDMARK® (sodium thiosulfate injection), which is indicated 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 FDA’s Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for PEDMARK® began on September 20, 2022, the date of its FDA approval, and continues until September 20, 2029. Additionally, in the approved prescribing label, the FDA has explicitly directed that PEDMARK® is not substitutable with other sodium thiosulfate products.1 “We are pleased that the FDA has granted Orphan Drug Exclusivity to PEDMARK®, which represents an important breakthrough treatment option for the pediatric cancer community,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “Further, as the first and only FDA approved drug for the treatment of pediatric cancer patients with localized, non-metastatic solid tumors at risk for cisplatin-induced hearing loss, we will continue to focus on strengthening our patent portfolio to extend intellectual property protection for PEDMARK® beyond the seven years provided with Orphan Drug Exclusivity.” In addition to Orphan Drug Exclusivity, PEDMARK® currently has three Orange Book listings for U.S. Patent No. 11,291,728 (‘728) and U.S. Patent No. 11,510,984 (‘984) that covers PEDMARK® pharmaceutical formulation and U.S. Patent No. 10,156,190 (‘190), which relates to a method of use for our PEDMARK® product. The ‘728 and ‘984 patents expire in 2039 and the ‘190 patent expires in 2038. About Cisplatin-Induced Ototoxicity 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.3 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.4 PEDMARK® (sodium thiosulfate injection) 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 durtion 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 Limitations of Use Important Safety Information 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 Forward Looking Statements 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. ©2023 Fennec Pharmaceuticals Inc. All rights reserved. FEN-1504-v1 For further information, please contact: Investors: Corporate and Media: 1 PEDMARK® Prescribing Information. 2 DOSAGE AND ADMINISTRATION |