Immune Pharmaceuticals Announces Formation of Management Team for Maxim Pharmaceuticals, its Pain and Neurology Subsidiary
Maxim Pharmaceuticals to focus dedicated financial resources to AmiKet® late stage development
Oct 17, 2016
NEW YORK, Oct. 17, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune") announced today that it has entered into a consulting agreement with Joseph V. Pergolizzi Jr., MD. Dr. Pergolizzi will form an operational management team, a Scientific Advisory Board, and a Board of Directors for Maxim Pharmaceuticals ("Maxim"), Immune's pain and neurology subsidiary, in order to advance the development of Amiket®. Maxim holds the rights to AmiKet, AmiKet NanoTM, and LidoPain® and will seek additional pain and neurology assets, preferably with 505(b)(2) development path possibilities.
Dr. Pergolizzi commented: "There is a significant unmet medical need in the treatment of peripheral neuropathic pain. AmiKet, a topical, may be able to match the efficacy of certain oral drugs, with a convenient and potentially safer administration. I intend to bring to Maxim, with the active support of Immune's CEO, Dr. Daniel Teper, a world class management team with experience in development and commercialization of pain and neurology drugs."
Dr. Pergolizzi is the co-founder and Chief Operating Officer of NEMA Research, a Clinical Research Organization, and president of Naples Anesthesia and Pain Associates of Naples, Florida. He has also held Chief Medical Officer positions at several pharmaceutical companies.
Dr. Pergolizzi's research interests focus on acute and chronic pain in adults with a particular focus on pain in the elderly. Dr. Pergolizzi has held positions including the co- founder and chairman of the board for the Association of Chronic Pain Patients, a member of the board of directors and treasurer for the Coalition for Pain Education (COPE), co- founder and director of research at the International Pain Research and Treatment Foundation, and a member of the board of directors of the National Institute of Pain. He is also chairman of the Abstract and Poster Selection Committee for PAINWeek and a member of the CHANGE PAIN Board.
AmiKet has completed phase 2 clinical trials in over 1,000 patients. In those studies, it has demonstrated comparable efficacy to oral gabapentin, the standard of care in the treatment of post herpetic neuralgia, a form of neuropathic pain. AmiKet is also developed for diabetic peripheral neuropathic pain and chemotherapy-induced neuropathic pain. A novel formulation, AmiKet Nano, may provide additional clinical benefits as well as extended patent exclusivity.
Immune has transferred AmiKet to Maxim in exchange for an equity position valued initially $15 Million and milestones of up to $145 Million as well as royalties on future sales.
About Immune Pharmaceuticals Inc.:
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in Phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma, and Non-Alcoholic Steato-Hepatitis (NASH), an inflammatory liver disease. Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune's oncology pipeline includes Ceplene® which is in late stage clinical development for maintenance remission in Acute Myeloid Leukemia (AML) in combination with IL-2. Additional products in the oncology pipeline include Azixa® and crolibulin, Phase II clinical stage vascular disrupting agents, and novel technology platforms; bispecific antibodies and NanomAbsTM. Maxim Pharmaceuticals Inc., Immune's pain and neurology subsidiary, is developing AmiKet and AmiKet Nano for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharma.com, the content of which is not a part of this press release.
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include, but are not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that clinical trials for bertilimumab, Ceplene, Azixa, AmiKet, AmiKet Nano, LidoPain, or NanoCyclo will not be successful; the risk that bertilimumab, AmiKet or compounds arising from our NanomAbs program will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet on attractive terms, on a timely basis or at all; the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing, and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials, and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property; risks associated with the contemplated transaction with NPT. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q, 10-K, and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings, which are available at www.sec.gov or at www.immunepharma.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties, or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Immune Pharmaceuticals Inc.
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