Fennec Pharmaceuticals Receives Positive Opinion on the Pediatric Investigation Plan From European Medicines Agency for PEDMARK(TM) and Confirmation of Eligibility for a Pediatric Use Marketing Authorization
As part of the regulatory process for registration of new medicines in
The PUMA is a dedicated marketing authorization covering the indication and appropriate formulation for medicines developed exclusively for use in the pediatric population and provides data and market protection up to 10 years for PEDMARK.
“The approval of our PIP and confirmation of PUMA eligibility represent significant regulatory milestones and steps forward in our efforts to bring PEDMARK to market in the
PEDMARKTM has been granted Orphan Drug, Breakthrough Therapy, and Fast Track Designations in
About PEDMARKTM (sodium thiosulfate/STS)
Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.
Each year in the
STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity: COG ACCL0431 and SIOPEL 6. Both studies are closed to recruitment. COG ACCL0431 enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. COG ACCL0431 final results were published in the Lancet Oncology. SIOPEL 6 final results were published in the
Forward looking statements
Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data 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, 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, 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
The scientific information discussed in this news release related to PEDMARKTM is preliminary and investigative. Such product candidates are not approved by the
For further information, please contact:
Chief Executive Officer
T: (919) 636-5144
Source: Fennec Pharmaceuticals Inc.