CEL-SCI Corporation 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).
According to a release, 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 tumour 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-II 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.
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. 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-tumour immune response can still be fully activated.
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.