Verastem, Inc. (VSTM) Files for Orphan Disease Status for VS-6063 in Mesothelioma
2/14/2013 9:52:10 AM
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Verastem, Inc., (NASDAQ: VSTM), a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced the filing of orphan drug designation for VS-6063. Verastem is seeking orphan drug designation in the US and the EU for the use of VS-6063 in mesothelioma. VS-6063 is anticipated to enter a potentially pivotal study in mesothelioma midyear 2013. Orphan designation grants US market exclusivity to a drug for the treatment of a specified condition for a period of seven years following FDA marketing approval and 10 years of market exclusivity in member states of the EU if received. Additional potential benefits of orphan designation include development grants, tax credits related to clinical trial expenses, protocol development assistance and exemption or reduction from certain regulatory fees.