Date: 2015-06-29
Type of information: Licensing agreement
Compound: topical nanoparticle formulation of Amiket
Company: Immune Pharmaceuticals (USA - MA, Israel) Yissum (Israel)
Therapeutic area: CNS diseases
Type agreement: licensing
Action mechanism: AmiKet is a topical drug for the treatment of neuropathic pain and has completed trials in more than 1700 patients, demonstrating comparable efficacy to the high dose of the oral standard of care, gabapentin, in a double-blind, placebo-controlled Phase II clinical trial. The newly formulated nano-topical AmiKet has the potential to provide longer exclusivity up to 2036, allow for the development of multiple chronic pain indications and support an improved product profile.
Disease: neuropathic pain
Details: * On June 29, 2015, Immune Pharmaceuticals announced that it has entered into a definitive license and research agreement with Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem, to license certain of Yissum's patents for the development and commercialization of a topical nano-formulated version of AmiKet, pursuant to the parties' existing binding memorandum of understanding from March 2015 (see below). Immune Pharmaceuticals has an extensive strategic partnership with Professor Benita, the former Director of the Institute for Drug Research and Dean of the School of Pharmacy at the Hebrew University of Jerusalem and Yissum, for the development of nano-pharmaceuticals. In addition to the new formulation of AmiKet, the collaboration includes NanomAbs®, antibody nano-particle conjugates for the targeted delivery of chemotherapy and a topical nano-formulated cyclosporine A for the treatment of psoriasis and atopic dermatitis. * On March 16, 2015, Immune Pharmaceuticals announced that it has entered into a binding memorandum of understanding with Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem, to license certain of Yissum’s patents in order to facilitate the development of a topical nanoparticle formulation of Immune’s neuropathic pain drug, Amiket™. The technology that Immune will be licensing was invented by Professor Simon Benita, from the Institute for Drug Research, the School of Pharmacy, and Faculty of Medicine at the Hebrew University, a renowned expert in development of drug delivery technology, and a primary inventor of NanomAbs, an antibody nanoparticle conjugate technology to deliver cancer drugs, already licensed by Immune from Yissum. Immune Pharmaceuticals is currently conducting a search for an appropriate partner for the final development and commercialization of Amiket, which is ready for Phase III clinical trial in post herpetic neuralgia and has been granted Orphan Drug Designation by the Food and Drug Administration. The Company expects to select a partner and secure a licensing agreement by the second quarter of 2015. The topical nanoparticle formulation of Amiket will be developed collaboratively by Immune and Yissum upon the execution of a license agreement between the parties and will be part of the Amiket commercialization agreement.
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