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European Commission Designates MST-188 As An Orphan Medicinal Product
Date:3/25/2013

may provide significant benefit to those affected by that condition.  

Authorized orphan medicines benefit from 10 years of marketing exclusivity in the European Union (EU), meaning that in the 10 years after marketing authorization similar products with a comparable indication cannot be placed on the market, except in limited circumstances.  This period of marketing exclusivity is extended by two years for medicines that also have complied with an agreed pediatric investigation plan.  The EMA also provides a form of scientific advice specifically for orphan medicines, called protocol assistance.  This allows sponsors to receive answers to questions on the types of studies needed to demonstrate the medicine's quality and benefits and risks.  In addition, all designated orphan medicines are assessed for marketing authorization centrally in the EU. This allows companies to make a single application to the EMA, resulting in a single opinion and a single decision from the EC, valid in all EU member states. 

About Mast Therapeutics

Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, CA.  The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop MST-188, its lead product candidate, for serious or life-threatening diseases with significant unmet needs.  MST-188 is a cytoprotective, hemorheologic, anti-inflammatory and anti-thrombotic agent that has potential utility in diseases or conditions characterized by microcirculatory insufficiency (endothelial dysfunction and/or impaired blood flow). 

The Company is recruiting subjects in EPIC, a pivotal phase 3 study of MST-188 in sickle cell disease.  The Company plans to initiate a phase 2 clinical study of M
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SOURCE Mast Therapeutics, Inc.
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