C-Mac
03-27-2005, 01:36 AM
http://www.medicalnewstoday.com/medicalnews.php?newsid=21836
Pfizer and Coley Pharmaceuticals Agreement on Promume for Cancers
26 Mar 2005
Pfizer Inc and Coley Pharmaceutical Group, Inc. said today they have entered into an exclusive global license agreement to develop, manufacture and commercialize Coley's ProMuneTM (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 tumor 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 hematologic tumors, 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.
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best-known consumer brands.
About Coley Pharmaceutical Group
Coley Pharmaceutical is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR TherapeuticsTM, a new class of drugs that direct the human immune system to treat cancers, infectious diseases, asthma and allergy. The company has established a broad pipeline with four TLR Therapeutic drug candidates currently advancing through clinical development either independently or with partners, and has additional leads in early-stage development. In addition to Pfizer, Coley has partnerships with Sanofi Aventis, GlaxoSmithKline, Chiron and the United States Government. For further information, please visit http://www.coleypharma.com.
DISCLOSURE NOTICE: The information contained in this document is as of March 24, 2005. Pfizer assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments.
This release contains forward-looking information about a product in development and the potential efficacy of such product that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainty of the success of the research and development activities; decisions by regulatory authorities regarding whether and when to approve any new drug application for a product candidate that may result from the research, as well as their decisions regarding labeling and other matters that could affect the commercial potential of such product candidate; and competitive developments.
A further list and description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2004, and in its reports on Form 10-Q and Form 8-K.
http://www.coleypharma.com/coley/pr_1111690283
Pfizer and Coley Pharmaceuticals Agreement on Promume for Cancers
26 Mar 2005
Pfizer Inc and Coley Pharmaceutical Group, Inc. said today they have entered into an exclusive global license agreement to develop, manufacture and commercialize Coley's ProMuneTM (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 tumor 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 hematologic tumors, 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.
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best-known consumer brands.
About Coley Pharmaceutical Group
Coley Pharmaceutical is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR TherapeuticsTM, a new class of drugs that direct the human immune system to treat cancers, infectious diseases, asthma and allergy. The company has established a broad pipeline with four TLR Therapeutic drug candidates currently advancing through clinical development either independently or with partners, and has additional leads in early-stage development. In addition to Pfizer, Coley has partnerships with Sanofi Aventis, GlaxoSmithKline, Chiron and the United States Government. For further information, please visit http://www.coleypharma.com.
DISCLOSURE NOTICE: The information contained in this document is as of March 24, 2005. Pfizer assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments.
This release contains forward-looking information about a product in development and the potential efficacy of such product that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainty of the success of the research and development activities; decisions by regulatory authorities regarding whether and when to approve any new drug application for a product candidate that may result from the research, as well as their decisions regarding labeling and other matters that could affect the commercial potential of such product candidate; and competitive developments.
A further list and description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2004, and in its reports on Form 10-Q and Form 8-K.
http://www.coleypharma.com/coley/pr_1111690283