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 (Israel and Turkey). 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.
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.
Geert Kersten, CEO of CEL-SCI, said: “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.”