Bertilimumab Granted Orphan Drug Designation for the Treatment of Bullous Pemphigoid
IMMUNE PHARMACEUTICALS INC NE (IMNP)
US:NASDAQ Investor Relations:
immunepharma.com/investor-relations
Company Research
Source: GlobeNewswire
ENGLEWOOD CLIFFS, N.J., Aug. 20, 2018 (GLOBE NEWSWIRE) -- Immune Pharmaceuticals, Inc. (OTCQB: IMNP) (“Immune” or the “Company”), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to bertilimumab for the treatment of bullous pemphigoid (BP). “We are incredibly gratified that bertilimumab has received Orphan Drug Designation for the treatment of bullous pemphigoid from the FDA and believe this designation, coupled with the recent positive opinion from the EMA’s Committee for Orphan Medicinal Products represent a significant regulatory milestone or bertilimumab,” commented Immune’s Chief Medical and Operating Officer, Tony Fiorino, MD, PhD. “We are focused on putting all of the manufacturing and regulatory pieces in place to launch a pivotal phase 2/3 study of bertilimumab in bullous pemphigoid next year.”
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