Coley Pharmaceutical Group Inc. entered a deal with Pfizer Inc. worth up to $505 million for its lead cancer drug, ProMune.
New York-based Pfizer gains exclusive worldwide rights to develop, manufacture and commercialize the Toll-like receptor 9 (TLR9) agonist, which is delivered by subcutaneous injection, and might treat, control and prevent certain cancers.
"We are really pleased that we found a partner like Pfizer to take ProMune the rest of the way," said Robert Bratzler, Coley's president and CEO. "They are committed to doing Phase III trials in non-small-cell lung cancer and several other selected cancer indications. So they provide not only the financial resources, but the human resources as well, and the commitment to help ProMune realize its full potential."
Terms of the agreement include a $50 million up-front payment to Coley, which also could receive up to $455 million in additional milestone payments based on reaching certain development and regulatory achievements. If the product gets approved, Coley would receive an undisclosed royalty on sales. Bratzler said the rate is comparable to the double-digit royalty deals that Coley has done with other pharmaceutical companies.
Under certain conditions, Pfizer may invest up to $10 million in Coley common stock if the privately held Wellesley, Mass.-based company decided to conduct an initial public offering. While nothing currently is planned, Bratzler said his management team constantly monitors the markets, and would file for an IPO when the time is right.
In the meantime, Pfizer will fund future development of ProMune, including planned Phase III trials to treat non-small-cell lung cancer (NSCLC) and studies in a variety of other tumor types. Pfizer also will cover costs of Coley research to discover and develop next-generation TLR9 agonists for cancers. If Coley finds new candidates, it may receive additional milestone payments and royalties from Pfizer.
"This deal gives some visibility to this whole field of TLR therapeutics, of which we are a pioneer," Bratzler told BioWorld Today.
Coley discovered ProMune in 1998 and took it into the clinic a year later. The license granted to Pfizer includes intellectual property licensed by Coley from the University of Iowa Research Foundation and the Ottawa Health Research Institute.
The product entered randomized Phase II trials in mid-2003. At a keynote symposium in Vancouver, British Columbia, in February, the company presented data showing that patients receiving ProMune plus standard chemotherapy achieved objective tumor responses more often than patients given chemotherapy alone.
"This is one of the few drugs that has ever been added on top of chemotherapy in first-line non-small-cell lung cancer and improved the outcome," Bratzler said. "In particular, we are seeing a trend toward a survival benefit in terms of progression-free survival and overall survival."
A potential ProMune competitor could be South San Francisco-based Genentech Inc.'s Avastin, which is marketed for colorectal cancer. Genentech released Phase III NSCLC data earlier this month showing that Avastin added to chemotherapy improved overall survival by 23 percent over chemotherapy alone. (See BioWorld Today, March 16, 2005.)
ProMune has been evaluated in clinical studies involving more than 900 people, demonstrating anticancer activity without substantial additional toxicity when it was used as a single agent or in combination with other treatments.
In addition to the trial for NSCLC, ProMune is in Phase II trials for malignant melanoma and cutaneous T-cell lymphoma. The product also is called CPG 7909, with CpG standing for cytosine and guanine separated by a phosphate.
Coley also has agreements with Paris-based Sanofi Aventis Group on an allergic asthma product entering Phase I development, with London-based GlaxoSmithKline plc for cancer vaccines, and with Emeryville, Calif.-based Chiron Corp. for infectious disease vaccines.
A second product in Coley's internal pipeline, Actilon, has entered a Phase Ib trial for chronic hepatitis C. The product is a TLR9 agonist designed to induce overproduction of interferon-alpha.
"Going forward, we will focus our internal development efforts on testing Actilon, not only in hepatitis C, but also other viral diseases as well," Bratzler said.