Pfizer Inc and Coley Pharmaceutical Group, Inc. said that they have entered into an exclusive global license agreement to develop, manufacture and commercialize Coley's ProMune (CPG 7909), a toll-like receptor 9 (TLR9) agonist delivered by subcutaneous injection for the potential treatment, control and prevention of cancers in humans.

Under the terms of the agreement, which is subject to government approval, Pfizer will make an initial payment of $50 million to Coley, with the potential for up to $455 million in additional milestone payments, plus royalties based on the successful development and commercialization of ProMune. In addition, under certain circumstances, Pfizer will invest up to $10 million in Coley's common stock upon an initial public offering by Coley.

Pfizer will fund future development of ProMune, including planned Phase III trials for the treatment of non-small cell lung cancer. A variety of additional tumour types also will be explored. Pfizer also will fund a collaboration with Coley to discover and develop next-generation TLR9 agonists for cancers, which, if successful, could result in additional milestone payments and royalties to Coley.

"Results of clinical studies conducted to date suggest that ProMune has promising anti-cancer activity and may represent an important advance in treating a range of cancer indications," said Karen Katen, vice chairman and president, Pfizer Human Health. "This agreement is a further step in our strategy to augment Pfizer's internal research activities with externally sourced products in key therapeutic areas such as oncology, where Pfizer is working to meet the needs of cancer patients."

"We are extremely proud of our progress with ProMune, as shown in Coley's randomized Phase II clinical trials," said Robert L. Bratzler, Ph.D., Coley's President and Chief Executive Officer. "We look forward to working with the Pfizer team to realize ProMune's remarkable potential as a highly potent and broadly applicable anti-cancer therapy."

ProMune has been evaluated in clinical studies involving more than 900 subjects. Promising initial anti-cancer activity without substantial additional toxicity has been observed in both solid and haematologic tumours, both as a single agent and in combination with other treatments. The technology licensed to Pfizer by Coley includes intellectual property licensed by Coley from the University of Iowa Research Foundation in Iowa City, Iowa and the Ottawa Health Research Institute in Ottawa, Canada.