August 19, 2008
CEL-SCI Announces Exclusive Licensing Agreement With Teva for Cancer Drug Multikine
VIENNA, Va., Aug. 19 /PRNewswire-FirstCall/ -- CEL-SCI Corporation announced today that it has entered into an exclusive licensing agreement with Teva Pharmaceutical Industries Ltd. (Teva), a leading global pharmaceutical company, under which CEL-SCI has granted Teva an exclusive license to market and distribute the Company's cancer drug Multikine for Israel and Turkey (the "Territory"). The licensing agreement is initially restricted to the areas of head and neck cancer. Teva has the right, subject to certain conditions, to extend the licensing agreement to include other cancers during the term of this agreement. Multikine is currently thought to be potentially useful in treating many tumor types.
Pursuant to the agreement, Teva will participate in CEL-SCI's upcoming global Phase III clinical trial. Teva will fund a portion of the Phase III clinical study and Teva's clinical group will conduct part of the clinical study in Israel under the auspices of CEL-SCI and its Clinical Research Organization. Teva will also be responsible for registering the product in the Territory. Once Multikine has been approved, CEL-SCI will be responsible for manufacturing the product, while Teva will be responsible for sales in the Territory. Revenues will be split 50/50 between CEL-SCI and Teva.
"We believe that Teva's expertise and knowledge in successfully conducting large pivotal clinical trials and in developing markets for large unmet medical needs will prove invaluable in maximizing Multikine's potential. This agreement is consistent with our strategy to share the clinical and regulatory expenses associated with the development of Multikine while retaining rights to market Multikine in North America and Europe," said Geert Kersten, Chief Executive Officer of CEL-SCI.
CEL-SCI is developing Multikine for approval as a first line indication in head and neck cancer. To that end, the Company's upcoming Phase III clinical trial is an 800 patient clinical study designed to demonstrate that administration of its cancer drug Multikine to head and neck cancer patients before they receive any conventional cancer treatment will increase their survival. Head and neck cancer is one of the world's biggest cancers affecting about 600,000 people per annum worldwide.
About CEL-SCI's Phase III Cancer Drug Multikine:
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007. In the summer of 2007 CEL-SCI started construction of the manufacturing facility to produce Multikine for the Phase III trial and subsequent sale following approval. This facility is expected to be completed soon.
Multikine, a patented defined mixture of naturally derived cytokines, is the first immunotherapeutic agent in a new class of drugs called "Immune SIMULATORS." Immune SIMULATORS simulate the way our natural immune system acts in defending us against cancer. As opposed to other immunotherapies which are designed to target a single or limited number of specific antigens or molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a direct and targeted killing of the specific tumor cells and they activate the immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.
CEL-SCI has operations in Vienna, Virginia and Baltimore, Maryland. CEL-SCI's other products, which are currently in pre-clinical stage, have shown protection against a number of diseases in animal tests and are being tested against diseases associated with bio-defense. Most recently CEL-SCI announced that its newly discovered rheumatoid arthritis vaccine showed excellent results in animal tests.
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
Web site: http://www.cel-sci.com/