AstraZeneca will make an initial payment of GBP16.3 million and will make a GBP7.5 million equity investment in Protherics to be paid in cash.
Protherics will receive additional payments worth up to GBP171 million payable upon the achievement of milestones. A significant proportion of these payments are contingent on pre-approval milestones being achieved. There are no milestone payments related to sales performance.
Under the terms of the agreement, AstraZeneca will undertake all clinical development work for CytoFab whilst Protherics will be primarily responsible for bulk drug manufacturing, including the supply of clinical trial material. The agreement is expected to become effective in early 2006.
Protherics will receive royalties on global product sales of 20% of net sales which reflect the late stage development status and market potential of CytoFab. Protherics will also receive additional payments in return for the commercial supply of the product and will invest to expand its manufacturing capacity accordingly
AstraZeneca plans to start the pivotal phase III study for CytoFab in the US and EU in 2007 following completion of improvements to the current manufacturing process.
Sepsis is a life-threatening condition resulting from uncontrolled severe infections which affects an estimated three million people a year worldwide. There is only one product currently available for the treatment of severe sepsis and there remains a considerable unmet need for treatment of this life-threatening condition.
“We are delighted to announce a major licensing deal with AstraZeneca for CytoFab,” said Dr Andrew Heath, Chief Executive of Protherics. “AstraZeneca has proven to be a focused and agile partner and as one of the leading pharmaceutical companies in the world, it has the clinical, regulatory and marketing strength to maximize the potential of CytoFab.”