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Soligenix and the European Medicines Agency Pediatric Committee Reach Agreement on the Pediatric Investigation Plan for SGX942
PRINCETON, N.J., April 9, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":"\n PRINCETON, N.J., April 9, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) agreed to the Company's Pediatric Investigation Plan (PIP) for SGX942 (dusquetide). It was also agreed that the Company may defer conducting the PIP until successful completion of its ongoing pivotal Phase 3 clinical study evaluating SGX942 as a treatment for oral mucositis in patients with head and neck cancer (HNC).\nAs part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA) for any new medicinal product in Europe. Soligenix will be able to file the adult indication MAA prior to completion of the PIP because the PDCO permitted the Company to defer conducting the pediatric program until the benefit/risk of treatment has been established in the adult population.\nFollowing a potential approval of the SGX942 MAA for treatment of oral mucositis in adult patients with HNC, Soligenix will work with PDCO and EMA to include appropriate pediatric data in the approved labeling.\n\"PDCO's agreement that we may defer conducting our PIP, allowing us to move forward with a potential submission and approval of an MAA in adults while initiating the pediatric development program, is an important step forward in our efforts to bring SGX942 to market,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"Likewise, acceptance of our PIP is an important regulatory milestone for the product, which also allows us to potentially expand the label to include appropriate pediatric data. Oral mucositis remains an extremely debilitating side effect of cancer treatment and is particularly severe and prevalent in HNC patients. Soligenix looks forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as quickly as possible.\"\nSoligenix is working with leading oncology...