AstraZeneca entered a global development and commercialisation agreement for Protherics anti-sepsis product CytoFab.
CytoFab is currently being prepared for a single phase III registration study in severe sepsis in line with guidance received at an end of phase II meeting with the US Food and Drug Administration, informs a company release.
AstraZeneca will be responsible for developing CytoFab, an anti-TNF-alpha polyclonal antibody fragment (Fab) product, as a treatment for TNF-alpha mediated diseases in man, with an initial target indication of severe sepsis.
Sepsis is a life-threatening condition resulting from uncontrolled severe infections which affects an estimated three million people a year worldwide.
Under the terms of the agreement, AstraZeneca will undertake all clinical development work for CytoFab and Protherics will be primarily responsible for bulk drug manufacturing, including the supply of clinical trial material. The agreement will become effective upon the expiration of the Hart-Scott-Rodino waiting period in the US, which is anticipated early in 2006.
The agreement has a potential total deal value, excluding royalties, of approximately £195 million to Protherics, including an initial payment of £16.3 million.
The release further stated that 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. Protherics has previously demonstrated in a phase IIb study that CytoFab caused a marked reduction in TNF-alpha in the blood and lung tissues of patients with severe sepsis, and that patients required on average five days’ less mechanical ventilation than when treated with placebo. In addition, CytoFab showed an encouraging trend suggesting a survival benefit compared to placebo and a favourable side-effect profile.
Dr John Patterson, executive director of development, AstraZeneca, said, “CytoFab is an exciting opportunity for AstraZeneca to extend its infection franchise. By working together with Protherics, we now have the opportunity to build on the excellent phase IIb data already generated. Our goal is to make CytoFab the standard of care for patients with sepsis, improving their chances of recovery and reducing their length of stay in intensive care. We hope it will provide clinicians with a new means of addressing this devastating condition and ultimately, help save lives.”