Stepping up the pace

MENLO PARK, Calif. – In an agreement aimed at accelerating the development of two antibiotics that exhibit broad-spectrum bactericidal activity against hospital-acquired infections, SRI International, an independent nonprofit R&D organization, and virtual pharma Blanca Pharmaceuticals have announced plans to jointly develop Blanca's carbacephem antibiotic drug candidates, now in late-stage preclinical development. Under terms of the agreement, Blanca will retain worldwide, exclusive commercialization rights to the compounds. SRI participates in the development and incubation efforts scientifically and has an option to take an ownership interest in Blanca.

The carbacephams are members of the class of bactericidal antibiotics that includes penicillin and the cephalosporins. Their activity profiles make the two compounds under development, BP-101 and BP-102, ideal candidates for empiric therapy against hospital-acquired infections when the causative pathogen is unknown, SRI claims. According to their estimates, five to ten percent of hospital patients acquire a drug-resistant infection. Medicinal chemistry research is also underway to discover oral formulations for the primary treatment of community-acquired infections and oral "step-down" therapy (switch from intravenous to oral form of antibiotic) for hospitalized patients.

SRI says the collaboration with Blanca came about via a series of events. "We had spun out a number of companies over the years, and now we wanted to 'spin in,'" says Edward Spack, Ph.D., senior director of business development in SRI's biosciences division. "We think we can fill the preclinical gap by accelerating sound projects with sound management." And Blanca qualifies, Spack continues, with Jim Rurka at the helm as chief business officer and George Miller—widely considered a leader in antibiotic research—on board as CSO.

From Blanca's perspective, the effort with SRI will focus on two objectives. The first will be capitalizing on SRI's successful experience as a grant recipient, Jim Rurka says. In fact, SRI claims to be the leading NIH grant recipient in the country and maintains a facility in nearby Virginia as a testimony to its success.

Second, Blanca will rely on SRI's preclinical drug development skills, initially to guide the two patented carbacephams through filing of IND applications with the FDA and, later, to ramp up the new company's drug discovery efforts.

"This program is an important addition to SRI's translational medicine activities that connect research to patient care," Ed Spack notes. Implicit in SRI's role with Blanca and other partners is the organization's "focus on long-term, important problems." This focus has contributed to SRI's enviable track record of having developed nine drugs internally that have reached clinical trials and more than 100 working with various partners. Over the years, more than 30 have been approved for use. With big pharma having largely abandoned their anti-infectives discovery activity, SRI's collaboration with Blanca is targeted at the discovery/early development niche, with a big pharma partner likely stepping in later.

When asked about the potential market for the two Blanca antibiotics, Rurka points to Pfizer's Zyvox, which is available both in parenteral and oral forms and is about a $600 million product in the U.S. "We think it's realistic that we might achieve a half-billion dollars in annual sales," he says.