Micrologix Biotech Inc. entered a deal with Fujisawa Healthcare Inc. to develop and market Micrologix's topical Phase III anti-infective product in a deal that could bring Micrologix as much as $21 million.

"[Fujisawa's] presence in the U.S. hospital market and its anti-infective products that it already has on the market make this a perfect fit," said Jonathan Burke, manager of investor and media relations at Micrologix.

Fujisawa's products include AmBisome (amphotericin B) liposome for injection, approved in 1997 by the FDA for use as empirical therapy for presumed fungal infections in patients with depressed immune function and fever of unknown origin.

Micrologix's product, MBI 226, is designed to prevent venous catheter-related bloodstream infections. Fujisawa, of Deerfield, Ill., a division of Fujisawa Pharmaceutical Co. Ltd., will pay future development costs and also will be responsible for manufacturing. In exchange, Fujisawa receives exclusive rights to the product in the U.S., Canada and Mexico.

Micrologix, which received a $1 million payment from Fujisawa in May while the companies negotiated their deal, could receive as much as $21 million more through an up-front payment and milestones. Also, Micrologix would receive an attractive 20 percent royalty on sales of an approved MBI 226 in the three regions.

The $1 million payment in May was used to continue enrollment in the MBI 226 Phase III trial while the framework for the deal was built. The trial, for the prevention of central venous catheter-related bloodstream infections, was initiated in the fall of 2000. Originally, the idea was to enroll between 1,000 and 1,500 patients, Burke said. The trial has enrolled about 1,100 patients to this point, but a joint committee formed by the companies will decide on the final number.

The composition of the committee, which also will set an estimated completion date for the trial, is "in the works and will be decided in 10 days," Burke told BioWorld Today.

MBI 226 is a cationic peptide that naturally occurs in most forms of life. The antibiotics Micrologix develops based on that technology are analogues with improved properties, the company said.

"They act in a physical nature, as opposed to a chemical nature," Burke said. "The mechanism of action is they penetrate the membrane. That causes pores to form and the bacteria die."

Burke said there are an estimated 5 million central venous catheters sold annually in the U.S., the first market for which Micrologix plans to seek approval. It hopes to fully penetrate the market and sell MBI 226 for $100 per catheter procedure. Other markets would follow.

"We are focusing on this clinical trial in the U.S. and then branching out from there," he said.

Micrologix also has MBI 594AN in a Phase II trial in 75 patients with mild to moderate acne. The product is topical and a cationic peptide, as well. The company completed a Phase IIa trial in November and expects to start a larger, longer-term Phase II trial after it resolves some manufacturing issues.

In May, Micrologix, of Vancouver, British Columbia, acquired two preclinical anti-infective programs from IntraBiotics Pharmaceuticals Inc., of Mountain View, Calif. As part of the acquisition, Micrologix signed a license and research agreement with BioSource Pharm Inc., of New York, for the compounds, although Micrologix still owns rights. Work on the programs is ongoing, Burke said.

But first up is MBI 226, now safely partnered.

"With [Fujisawa] being an established leader in the industry, it makes an outstanding partner for our first product," Burke said.

Micrologix's stock (TSE:MBI) rose C34 cents Tuesday, or 47.9 percent, to close at C$1.05.