West Coast Editor

The day after it disclosed it had filed an investigational new drug application for the cancer compound XL999, Exelixis Inc. said the company plans to restructure and consolidate, cutting 62 positions, or 11 percent of the company's work force, in an effort to streamline operations and generate still more INDs.

"It's effective today," Jane Green, vice president of corporate communications for Exelixis, said Wednesday.

Most of the head count reductions are in the company's research organization and are expected to save Exelixis at least $5 million this year (excluding the second-quarter restructuring charge of $2 million) and at least $10 million in 2005 and beyond. The company said it would formally update 2004 expense and cash guidance when the second-quarter report is disclosed.

Exelixis said Tuesday an IND was submitted for XL999, a cancer compound that has shown inhibition in vivo against multiple receptor tyrosine kinases implicated in tumor angiogenesis. About a week ago, the firm began a Phase III trial in bile duct cancer with another product candidate, XL119. (See BioWorld Today, June 24, 2004.)

Awaiting IND filing are XL844, XL820 and XL880, all of which could go to the FDA as early as the first half of next year, the company said. Though which might be first is difficult to say, Green told BioWorld Today.

"They're all high-value programs, all proceeding apace," she said, although "among the most exciting is XL880. We've said publicly that this is a really fascinating program, and we're trying to pull out all the stops to advance it. The biological profile of the drug shows it's very potent as an antitumor agent."

Further along in the pipeline is XL784, an inhibitor of the ADAM-10 metalloprotease enzyme, which has completed a Phase I trial. XL647, targeting multiple receptor tyrosine kinases in patients with solid tumors, also is in Phase I work.

A key aspect of the restructuring is the consolidation of the research and discovery groups into a single unit, Green said.

The South San Francisco-based company has defined "research" as work in model systems, genetics and functional genomics for finding and validating targets, she said. Whereas "discovery" has been defined as "activities designed to identify and advance lead compounds and get them ready for IND-enabling studies."

Exelixis separated them "because we've had such a significant effort going on in functional genomics," Green added. In combining the two, more effort will be placed on what previously was regarded as discovery.

"That's exactly the trend in the company just now," she said. "That's the business we're in."

No Comments