Washington Editor

Biosynexus and GlaxoSmithKline Biologicals entered a deal worth $120 million to Biosynexus for the development of vaccines and antibodies designed to fight infections caused by staphylococcal bacteria.

Biosynexus' lead product, BSYX-A110, a monoclonal antibody for preventing staphylococcal infections in neonates and adults, is included in the agreement.

"This alliance is an outstanding opportunity to combine our medical and scientific capabilities with GlaxoSmithKline's manufacturing and global marketing and sales capabilities so that we can move this product through clinical trials and get it out there to help people as quickly as possible," Gerald Fischer, president and CEO of Gaithersburg, Md.-based Biosynexus, told BioWorld Today.

The exclusive agreement calls for the companies to co-develop BSYX-A110 and to allow GSK, of Rixensart, Belgium, to develop staphylococcal vaccines using Biosynexus' antigen discovery and conjugation technologies. GlaxoSmithKline Biologicals is a unit of GlaxoSmithKline plc, of London.

Fischer said each company would share the costs of developing BSYX-A110, as well as other products that could be discovered via the agreement. In exchange, Biosynexus could pull in upward of $120 million through access fees, equity investments and milestone payments.

While Fischer would not discuss details of up-front payments, he described them as "very significant."

Also, terms call for Biosynexus to co-promote monoclonal antibody technology in the U.S. and share in the profits. GSK Biologicals would market the product outside the U.S. and Biosynexus would receive royalties.

Biosynexus, a private company, was founded in 1999 as a spin-off of Virion Systems Inc., of Rockville, Md., and Sunol Molecular Corp., of Miramar, Fla. Fischer left his position as president and CEO of Virion to run Biosynexus.

The company employs 35 to 40 people and raised in excess of $25 million in three rounds of financing. (That total does not include payments from the GSK deal.)

"We've been quite stealthy about what we are doing," Fischer said. "We have simply devoted our time and effort to getting the products properly through preclinical and clinical development and we chose what we thought was the opportune and appropriate time to form this strategic alliance so that it would be a good opportunity for both parties."

Already Biosynexus has successfully guided BSYX-A110 through Phase I adult trials, where the product met safety and tolerability targets and demonstrated outstanding pharmacokinetic and pharmacodynamic capabilities, Fischer said. BSYX-A110 also is in Phase I/II trials in premature babies.

"We are a young company, but we have accomplished a lot and it is the success of this product that has driven the deal," Fischer said.

He added that key scientists at both GSK and Biosynexus have worked together for the past 10 years developing vaccines. Indeed, as the head of Virion, Fischer was involved in licensing agreements with SmithKline Beecham.

Aside from BSYX-A110, Biosynexus is developing two other products that are not included in the GSK deal. One is lysostaphin intranasal, a cream formulated with lysostaphin for use in the nose to eradicate S. aureus colonization. Fischer expects to enter clinical trials in the next few months. The other product is lysostaphin IV for staphylococcal infections, also in preclinical development.