Immune Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for Bertilimumab for the Treatment of Bullous Pemphigoid
ENGLEWOOD CLIFFS, N.J., July 30, 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 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.
About Immune Pharmaceuticals, Inc.
Immune Pharmaceuticals, Inc. is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Immune’s lead program, bertilimumab, is a first-in-class, human monoclonal antibody that binds eotaxin-1, a chemokine that attracts eosinophils to the site of inflammation. By blocking eotaxin-1, bertilimumab may prevent the migration and activation of eosinophils and other cells, thus blocking an important inflammatory pathway active in a variety of allergic and immune diseases. Bertilimumab has shown promising clinical activity in bullous pemphigoid and has been studied in other conditions including allergic rhinitis and ulcerative colitis, and may have application in other diseases, including atopic dermatitis, asthma, and other diseases. Immune is also developing NanoCyclo, a nano-encapsulated formulation of cyclosporin, which is in late stage preclinical development for atopic dermatitis and psoriasis.
Safe Harbor Statements Regarding Forward Looking Statements
The statements in this news release made by representatives of Immune relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Immune’s product candidates and the sufficiency of Immune’s cash and other capital resources, the continued development by Immune of bertilimumab or its determination to seek Orphan Drug designation for the pharmaceutical product of bertilimumab are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Immune’s ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Immune’s filings with the Securities and Exchange Commission, including those discussed in Immune’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and periodic reports filed on Form 8-K.
SOURCE Immune Pharmaceuticals Inc.
Released July 30, 2018