By Brady Huggett

Millennium Pharmaceuticals Inc. and privately held BZL Biologics LLC will develop and commercialize antibody-based therapeutics targeting prostate-specific membrane antigen in a deal that marks Millennium's first in-licensing deal and the end of BZL.

The deal states the companies will work jointly on development programs for immunotoxin and radiolabeled products for prostate cancer based on prostate-specific membrane antigen (PSMA) through Phase II trials. From that point on, Millennium will shoulder full responsibility for development, manufacturing and commercialization of all antibody-based therapies for all indications, and also diagnostic products. Millennium also will pay all development costs.

PSMA is expressed by prostate tumors, and the level of expression increases with tumor progression. Neil Bander, a consultant to BZL, heads the team that discovered the anti-PSMA antibodies and is one of the reasons Millennium became interested in BZL.

"It was him and his work," said John Maraganore, senior vice president, strategic product development at Millennium. "In addition to that, BZL is very well known among the prostate cancer community. This antibody is one of the more exciting agents for prostate cancer."

BZL, of Framingham, Mass., will be entitled to milestones and royalties on any marketed products. Although neither side would comment on specifics of the deal, Dennis Goldberg, CEO of BZL, was pleased with what the company is getting.

"We turned down typical early stage offers years ago and this is a much, much bigger deal than [those]," he said.

Having entered the deal with Millennium, BZL will now prepare to ride off into the sunset. Goldberg said BZL, basically a virtual company that sits under an umbrella called New Drug Associates, located in Framingham, never planned on sticking it out for the long run.

"We wanted to maximize our assets and we felt this allowed us to do that," said Goldberg, who also is CEO of New Drug Associates. "We never had the strategy to be a publicly traded company. We felt the strategy was to move [the product] along, find a partner, and collaborate on the development." When that is done, he added, the company will divide up the revenues and move on.

New Drug Associates is made up of several companies like BZL, companies with a single goal that, when achieved, signifies their end.

"It's a different model for developing products," Goldberg said.

For Millennium, of Cambridge, Mass., the deal is the virgin step off its historical path.

"This represents our first in-licensing of a product," Maraganore said, adding that the best way to build Millennium is to add in-licensing to its internal pipeline efforts. The agreement with BZL is "consistent with and part of" Millennium's overall strategy of developing "breakthrough medicines for the treatment of disease," he said.

PSMA will be used as a target in prostate tumor cells for an antibody - with either a radiolabel or immunotoxin attached. In March, Millennium signed a deal with ImmunoGen Inc., of Cambridge, Mass., for ImmunoGen's Tumor-Activated Prodrug (TAP) method of delivering cytotoxic agents, a deal that was done "in sync" with the BZL deal, Maraganore said. (See BioWorld Today, March 7, 2001.)

PSMA, besides being present in prostate tumors, also is found in the neovasculature of other tumors, Maraganore said. Beyond the work in prostate cancer, Millennium and BZL will work toward lung and colorectal cancer, with Millennium in control and BZL collaborating.

Maraganore said the prostate cancer agreement fits Millennium's preferred pace of drug development.

"Oncology is important for us because trials can be done using smaller populations of patients," he said. "[Cancer] has a more targeted development timeline, and that goes along with our strategy of bringing drugs to market as quickly as possible."

Millennium's stock (NASDAQ:MLNM) dropped 86 cents Wednesday to close at $31.01.