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Note 1 - Organization and Description of Business
6 Months Ended
Jun. 30, 2013
Disclosure Text Block [Abstract]  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]

1. Organization and Description of Business


EpiCept is a specialty pharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of pain and cancer. The Company’s strategy is to focus on topically delivered analgesics targeting peripheral nerve receptors and on innovative cancer therapies. In November 2012, the Company entered into a definitive merger agreement with Immune Pharmaceuticals Ltd. (“Immune”), and recently filed a definitive proxy statement that contains details on Immune and the merger. The definitive proxy was mailed to shareholders on or about June 20, 2013. The transaction is anticipated to close in August 2013 and is subject to satisfaction of certain customary closing conditions, including the approval of a reverse split of EpiCept’ s common stock by a majority of EpiCept shareholders.


The combined entity, to be named Immune Pharmaceuticals, Inc., will be primarily focused on developing antibody therapeutics and other targeted drugs for the treatment of inflammatory diseases and cancer. Immune’s lead product candidate, bertilimumab, is a fully human monoclonal antibody that targets eotaxin-1, a chemokine involved in eosinophilic inflammation, angiogenesis and neurogenesis. Immune is currently initiating a placebo-controlled, double-blind Phase II clinical trial with bertilimumab for the treatment of ulcerative colitis. The following results of operations and discussion of business are of EpiCept only and do not represent the prospective combined entity.


The Company’s lead compound is AmiKet™, a topical cream consisting of a patented combination of amitriptyline and ketamine that is in late stage development for the treatment of peripheral neuropathies. In December 2011, the Company met with the Food and Drug Administration (“FDA”) and was granted permission by the FDA to begin Phase III clinical development. Fast Track designation was granted in April 2012. In June 2012, EpiCept announced that it had received formal scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for AmiKet’s clinical and nonclinical development and subsequent Marketing Authorization Approval (MAA).


The Company’s oncology compounds include crolibulinTM and Azixa®. CrolibulinTM is a novel small molecule vascular disruption agent (“VDA”) and apoptosis inducer for the treatment of patients with solid tumors that is currently in a Phase Ib/II clinical trial sponsored by the National Cancer Institute (“NCI”) to assess the drug’s efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (“ATC”). Azixa®, an apoptosis inducer with VDA activity previously licensed by the Company to Myrexis, Inc. (“Myrexis”), as part of an exclusive, worldwide development and commercialization agreement, is currently in Phase II development for the treatment of brain cancer. In August 2012, Myrexis elected to terminate the license agreement resulting in the reversion of all rights and licenses granted under the license agreement back to the Company. In January 2013, the Company negotiated with Myrexis to license the Myriad patents and know-how as set forth in the License Agreement. Under the agreement, the Company will be responsible for paying milestone payments and royalties to Myrexis if the Company decides to further develop Azixa® itself, or to share in milestones and royalties the Company receives from a partner in the event it out-licenses the drug candidate to a third party who successfully completes product development and obtains marketing approval. The Company has no plans to pursue further development of Azixa® on its own.


Ceplene®, when used concomitantly with low-dose interleukin-2, or IL-2, is intended as remission maintenance therapy in the treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete remission. The Company sold all of its rights to Ceplene® in Europe and certain Pacific Rim countries and a portion of its remaining Ceplene® inventory to Meda AB for approximately $2.6 million in June 2012. Ceplene® is licensed to MegaPharm Ltd. to market and sell in Israel, where it is currently available on a named-patient basis. The Company has retained its rights to Ceplene® in all other countries, including countries in North and South America, but at the current time has no plans to continue clinical development.