October 23, 2019
TRPHARM A.S. today announced that the Turkish Drug and Medical Devices Agency have approved a Compassionate Use Program (CUP) in Turkey for PEDMARK™ (a unique formulation of sodium thiosulfate (STS) developed by Fennec Pharmaceuticals) for the protection from Cisplatin-Induced Hearing Loss in children who have standard risk hepatoblastoma.
Fennec Pharmaceuticals has initiated a rolling New Drug Application (NDA) in the United States for PEDMARK™ and expect to complete the regulatory filings in early 2020 in the US and Europe. PEDMARK™ has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations from the FDA.
Mehmet Göker, CEO of TRPHARM, commented that “At TRPHARM, our priority is to address the needs of the patients that are most at risk and provide them better health services. This milestone, is among the first achievements of our new Medical Services business that shows our commitment to accelerate access to innovation. In addition, the collaboration we have with Fennec Pharmaceuticals Inc. showcases our unique business model of building a robust relationship with our partners.”
Rosty Raykov, President and Chief Executive Officer of Fennec, pointed out that “As part of our commitment to patients, and where regulations allow, we hope to provide PEDMARK via compassionate use programs as we continue to work with the FDA and EMA to gain a product approval in this area of unmet medical need.”
About TRPHARM A.S.
TRPHARM is a commercial stage pharmaceutical company and the partner in Turkey and MENA for growing biopharmaceutical companies based in developed markets that want to expand their horizon to emerging markets and optimize the revenue potential of their products while managing their resources and risk.
Besides its investments in R&D and manufacturing, TRPHARM acts like a regional affiliate for its partners, carrying out all required activities from late stage development to commercial maturity. TRPHARM has a wide product portfolio, led by oncology, rare diseases, and neurology. For more information, please visit www.trpharm.com.
About Fennec Pharmaceuticals Inc.
Fennec Pharmaceuticals Inc., is a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients. Fennec initiated a rolling New Drug Application (NDA) for PEDMARK™ for the prevention of ototoxicity induced by cisplatin chemotherapy patients 1 month to < 18 years of age with localized, non-metastatic, solid tumors in December 2018. The Company is targeting completing the NDA submission in early 2020 with potential first commercial launch of PEDMARK™ in the second half of 2020. Further, PEDMARK™ received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to STS and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com.
About PEDMARK™ (Sodium Thiosulfate (STS))
Cisplatin and other platinum compounds are essential chemotherapeutic components for many paediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of paediatric cancer.
In the U.S. and Europe there is estimated that over 10,000 children may receive platinum-based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, though many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss. Hearing loss affecting infants and young children at critical stages of development leads to a lack of speech language development and literacy, in older children and adolescents a lack of social-emotional development and educational achievement is also observed
STS has been studied by cooperative groups in two Phase 3 clinical studies that observed effect on survival and on the reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed.
For further information, please contact:
Ozan Efe Ertem
Business Development, Sr. Manager
TRPHARM İlaç San. Tic. A.S.