CEL-SCI Corporation (NYSE AMEX: CVM) today announced that it has entered into an exclusive Sales, Marketing and Distribution agreement with IDC-GP Pharm LLC (“IDC-GP Pharm”) under which CEL-SCI has granted IDC-GP Pharm an exclusive license to market and distribute the Company’s investigational cancer therapy, Multikine ® (Leukocyte Interleukin, Injection)* in the countries of Argentina and Venezuela (the “Territory”). IDC-GP Pharm is a Joint Venture between two groups of experienced pharmaceutical entrepreneurs with expertise in the registration and commercialization of pharmaceutical products in South America, among other regions. One of these two groups represents former employees of a large pharmaceutical company, while the other group is GP Pharm ( http://www.gp-pharm.com/), headquartered in Barcelona, Spain, with operations in each major country in Latin America either directly or through local partners. CEL-SCI already has existing licensing agreements for Multikine (Leukocyte Interleukin, Injection) with Teva Pharmaceuticals Industries Ltd., Orient Europharma Co. Ltd. and Byron Pharmaceuticals.
Pursuant to the agreement, IDC-GP Pharm will be responsible for receiving regulatory approval to use Multikine (Leukocyte Interleukin, Injection) in the territory. Once Multikine (Leukocyte Interleukin, Injection) has been approved in any of the two countries, CEL-SCI will be responsible for manufacturing the product, while IDC-GP Pharm will be responsible for sales in the Territory. Revenues will be split 50/50 between CEL-SCI and IDC-GP Pharm after payment to CEL-SCI for the manufacturing costs of Multikine (Leukocyte Interleukin, Injection).
“This agreement is consistent with CEL-SCI’s strategy to license Multikine (Leukocyte Interleukin, Injection) in the emerging markets,” said Geert Kersten, Chief Executive Officer of CEL-SCI.
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for treatment of head and neck cancer.Multikine (Leukocyte Interleukin, Injection) is currently being investigated in an open-label, randomized, controlled, multi-center study designed to determine if Multikine (Leukocyte Interleukin, Injection) administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for treatment naive (yet untreated) subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. It is the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. A detailed description of the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1. In Phase II clinical studies, subjects with locally advanced disease who received the investigational therapy Multikine (Leukocyte Interleukin, Injection) as first-line investigational treatment were observed to have demonstrated a 33% increase in overall survival rate as compared to the overall survival rate that was determined from a review of 55 trials of the same cancer population, which were reported (in the scientific literature) between 1987 and 2007. However, no definitive conclusions can be drawn from these data about the potential efficacy profile of this investigational therapy. Moreover, further research is required, and these results must be confirmed in a well-controlled Phase III clinical trial of this investigational therapy that is currently in progress. Subject to completion of that Phase III trial and FDA’s review of our entire data set on this investigational therapy, CEL-SCI believes that these early-stage clinical trial results indicate the potential for this investigational therapy to be a breakthrough in the treatment of advanced primary head and neck cancer. The U.S. Food and Drug Administration also granted orphan drug status to Multikine (Leukocyte Interleukin, Injection) in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
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