Three-year-old Blanca Pharmaceuticals LLC is teaming up with nonprofit research organization SRI International Inc. to complete preclinical development of antibiotics BP-101 and BP-102.

Both drugs combine a novel carbacephem compound with the beta-lactamase inhibitor tazobactam. Blanca's Chief Business Officer Jim Rurka said the carbacephem provides broad-spectrum bactericidal activity against Gram-positive bacteria, such as methicillin-resistant staphylococcus aureus and epidermidis (MRSA/E), penicillin-resistant streptococcus pneumoniae (PRSP) and vancomycin-resistant enterococcus (VRE), while the tazobactam increases the drugs' potency and addresses most Gram-negative bacteria.

Preclinical studies of BP-102 demonstrated potent activity in vitro against Gram-positive and Gram-negative bacteria, and a recent study indicated activity against anaerobes as well, Rurka said. In vivo studies completed include pharmacokinetics, efficacy, safety and tolerance. To date, preclinical work has focused on BP-102, a parenteral formulation, but new data indicating BP-101 may have better oral absorption prompted Blanca to bring the second compound up to speed.

"The Holy Grail is a matched pair of oral and parenteral [drugs] that can be given in both hospital and community settings," Rurka said.

Under the new partnership, SRI will handle the GLP toxicology studies needed for IND filings with BP-102 and BP-101. Rurka estimated the remaining preclinical work will take "more than a year but less than five" years to complete. Blanca's four-person team will take up residence on SRI's Menlo Park, Calif. campus so the two groups can collaborate closely.

Founded in 2003, Blanca's name reflects the founding scientists' enthusiasm for carbacephem compounds - and specifically their search for a Beta-Lactamase Anti-MRSA Non-Cephalosporin Antibiotic. Blanca is self-funded, but Rurka acknowledged that the company will use grants to pay for some of the preclinical work and may need to access some public or private funding.

In exchange for serving as Blanca's incubator, SRI reserves the option to take an ownership interest in the company. Blanca will retain worldwide, exclusive commercialization rights to both BP-102 and BP-101.

SRI, founded in 1946 as the translational arm of Stanford University, has contributed to such breakthroughs as the computer mouse and the internet. Its biosciences division conducts basic research, drug discovery and preclinical contract research that have helped put more than 100 drugs into the clinic and more than 30 onto the market.

As the largest preclinical development contractor to the National Institutes of Health, SRI is no stranger to antibacterial and anti-infective research. Last fall, it won a $56.9 million contract from the National Institute of Allergy and Infectious Diseases to conduct preclinical services in support of anti-infective therapeutics. (See BioWorld Today, Nov. 10, 2006.)

In the private sector, however, interest in antibacterials has waned at some big pharma companies. One case in point is Lorabid (loracarbef), the only carbacephem antibiotic to gain FDA approval, according to Rurka. In 1999, Eli Lilly and Co., of Indianapolis, passed off U.S. marketing rights to the drug to King Pharmaceuticals Inc., which discontinued making it late last year.

Yet the need for antibiotics, especially those that address resistant strains, continues to grow - even if the transient nature of their use makes them less likely to become blockbusters. The NIH estimates that more than 70 percent of the bacteria responsible for hospital-acquired infections are resistant to at least one of the antibiotics commonly used to treat them, and studies show that resistance is increasing in community settings as well.

"Our nonprofit status gives us the freedom to tackle important problems," said Edward Spack, senior director of business development in SRI's Biosciences division.

Biotech has also stepped up to the plate. Some, like Cubist Pharmaceuticals Inc., of Lexington, Mass., have taken over products abandoned by big pharma. Licensed from Eli Lilly in 1997, Cubicin (daptomycin injection) brought Cubist $190.3 million in 2006 U.S. sales as well as seven partnerships for ex-U.S. sales. Similarly, oritavancin passed from Eli Lilly to InterMune Inc. to Targanta Therapeutics, which is now preparing to file an NDA for the drug.

Fewer biotechs are developing their own new classes of antibacterial agents. One, Affinium Pharmaceuticals Inc., of Toronto, recently raised $18 million in a Series A to advance anti-infective drugs targeting the bacterial fatty acid biosynthesis (Fab) pathway. (See BioWorld Today, March 27, 2007.)

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