FDA Chooses Zepsyre™ (PM1183) from PharmaMar to Explore Potential Development for Pediatric Cancers

MADRID, June 20, 2017

The Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) of the FDA, has invited PharmaMar to participate in this ODAC, giving a presentation to provide background information on Zepsyre™, positive clinical data obtained from phases I and II, in which a good tolerance and a good safety profile were observed, and to assess the potential role of this drug in pediatric cancers and hematological disorders.

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Zepsyre™ (PM1183), PharmaMar´s investigational drug, is one of the three products chosen by ODAC.

The subcommittee will consider and discuss with PharmaMar issues concerning the diseases to be studied, patient populations to be included and possible study designs in the development of this product for pediatric use. The discussion will also provide the FDA with guidance to facilitate formulation of Written Requests for pediatric studies, if appropriate.

According to Luis Mora, Managing Director of the Oncology Unit at PharmaMar, "we are pleased to have been chosen to participate in the Pediatric Subcommittee meeting. Given the mechanism of action of Zepsyre™ as well as the available clinical data from phases I and II, in which we observed a good tolerance and a good safety profile, we believe that there may be potential relevance for PM1183 to be developed in one or more pediatric cancers. PharmaMar is a willing participant at this meeting and we hope it is going to be helpful for patients and investigators as well as the FDA".

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