By Randall Osborne

West Coast Editor

Potential applications for Cubist Pharmaceuticals Inc.'s daptomycin product are spreading almost like the infections it is intended to cure, and the company said FDA officials gave the go-ahead for a Phase III trial to test injectable Cidecin against community-acquired pneumonia and complicated urinary tract infection.

Trials are expected to begin this fall, said Scott Rocklage, chairman, president and CEO of Cambridge, Mass.-based Cubist. "Basically, it's mechanical issues [that remain to be handled]," such as getting drugs to about 150 study sites, Rocklage said. The timetable works out well, since fall is pneumonia season, he added.

Daptomycin, a novel cyclic lipopeptide antibiotic derived from a fermentation product of Streptomyces roseosporous, has shown potent activity against all Gram-positive bacteria.

It's in Phase III trials for skin and soft-tissue infections, with 400 patients enrolled so far and completion of enrollment expected by the end of this year, and data due in the first half of 2001.

Phase IIb trials are testing Cidecin for bacteremia, or bloodstream infections. Another Phase III trial is expected to begin for endocarditis in the fourth quarter of this year.

"All of it is the same formulation, the same drug," Rocklage said. "The good news is that the FDA has verbally said that daptomycin appears to qualify for fast-track review status."

The plan is to test Cidecin in various indications, and seek a new drug application for all of them at once, he said. "Clinical enrollment will determine launch time," he added, and complicated urinary tract infections may prove most challenging there.

"Overall, as an area, it's not that challenging, because there are lots of people with infections," Rocklage said, noting that 9 million people are hospitalized annually worldwide with hospital-acquired infections.

Although Cubist is not taking on sepsis, which has long been a bugaboo of biotech, Cidecin attacks the problem in a sense, Rocklage said. "Sepsis is the endpoint of an uncontrolled infection, combined with other biological processes," he said. "If you can control infection, you can often modulate the pathway to sepsis, [which is] a whole different set of things, Gram-negative and Gram-positive."

Cubist is conducting trials in North America, Europe, Israel, South Africa and Australia. Daptomycin "is the key [product], because it's the most advanced, but the follow-on products are initially from the same chemical class of lipopeptides," Rocklage said.

At the end of the second quarter, Cubist expected to have about $155 million, with a burn rate in 2000 anticipated at $32 million to $34 million. Last year's burn rate was $18 million, and rose because of the number of trial sites, Rocklage said.

"It's not going to increase dramatically next year, based on the current operating plan," he said.

Cubist's stock (NASDAQ:CBST) closed Thursday at $46, down $2.625.

No Comments