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Bertilimumab Granted Fast Track Designation for the Treatment of Bullous Pemphigoid

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Thursday, September 13, 2018

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FORT LEE, NJ - Immune Pharmaceuticals, Inc. (OTCQB: IMNP) (“Immune” or the “Company”), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to bertilimumab for the treatment of bullous pemphigoid.

“I am truly grateful that the FDA has granted Fast Track designation to bertilimumab for the treatment of bullous pemphigoid. This important achievement follows the recent granting of Orphan Drug Designation in both the United States and Europe, which together demonstrate the regulatory affairs momentum our team has achieved,” commented Immune’s Interim Chief Executive Officer, Tony Fiorino, MD, PhD. “There is no doubt that bertilimumab development will benefit from the opportunity to have more frequent contact with the FDA, particularly now, as we move forward with a new manufacturing process and plan for a phase 2/3 pivotal study in bullous pemphigoid.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions that are unmet medical needs. Fast Track designation enables more frequent interactions with the FDA in order to shorten the development and review process, and may include potential eligibility for Accelerated Approval, Priority Review and Rolling Review.

CONFERENCE CALL AND WEBCAST DETAILS
Immune will host a live conference call and webcast to provide a corporate update on Thursday, September 13, 2018 at 8:30 a.m. EDT.

To participate in the call, please dial 877-407-9122 (domestic) or 201-493-6747 (international). The live webcast will be available on the Events page of the Investors section of the Company’s website (https://www.immunepharma.com/), and will be archived for 60 days.

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 targets eotaxin-1, a chemokine that plays a role in immune responses and 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

Contact:
Investors@immunepharma.com

Source: Immune Pharmaceuticals
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