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September 29, 2016

EMA Paediatric Committee (PDCO) granted a waiver for MC2-03 PAD ™ Eye Drop

Acceptance of this waiver for the Paediatric Investigation Plan (PIP) paves the way for the potential submission of a Marketing Authorization Application (MAA) in Europe following completion of the ongoing clinical program with PAD-ciclo.

Copenhagen, September 29, 2016, MC2 Biotek, a clinical stage emerging specialty pharmaceutical company specialized in dermatology and ophthalmology, announced today that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) granted a waiver agreeing the company’s position on the PIP for MC2-03 PAD ™ Eye Drop (ciclosporin 0.06%).

As 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 pediatric population. An accepted PIP or a waiver for the PIP is a prerequisite for the filing for marketing authorization for any new medicinal product in Europe.

Jesper J. Lange, President of MC2 Biotek said: “This PIP waiver acceptance is the first regulatory milestone in Europe for MC2-03 PAD ™ Eye Drop, and we are thrilled to see that our clinical program backed by Scientific Advices received from National Competent Authorities continues to move forward. Our team at MC2 Biotek has worked diligently to achieve this milestone”. Jesper J. Lange added: “Our goal is to develop a ciclosporin eye drop that is be the best-in-class treatment for patients suffering from dry eye disease“.

About MC2-03 PAD ™ Eye Drop

MC2 Biotek is developing MC2-03 PAD ™ Eye Drop for the treatment of dry eye disease, a drug candidate derived from its PAD ™ Technology platform. MC2-03 is currently being investigated in a large phase II trial for treatment of dry eye disease.

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