Immune Pharmaceuticals, Inc., a Englewood Cliffs-based biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the company’s application for Orphan Drug Designation for bertilimumab for the treatment of bullous pemphigoid (BP).
“We are pleased that the COMP has issued its opinion in support of our request for orphan designation for bertilimumab for the treatment of bullous pemphigoid.” commented Immune’s Chief Medical and Operating Officer, Tony Fiorino, MD, PhD. “Our data suggest that blocking eotaxin-1 can have important clinical benefits for patients with moderate-to-extensive disease. We intend to make use of the enhanced regulatory support enabled by receiving orphan drug designation from the EMA as we prepare for our planned pivotal phase 2/3 study of bertilimumab in bullous pemphigoid, expected to launch in 2019.”
The COMP’s positive opinion will be sent to the European Commission, which is expected to grant the orphan drug designation within 30 days. In addition to a 10-year period of marketing exclusivity in the European Union (EU) after product approval, orphan designation also provides incentives for companies seeking to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, including reduced regulatory fees, protocol assistance from the EMA during product development, and direct access to the centralized authorization procedure, allowing companies to make a single application to the EMA and potentially to gain conditional approval.
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