Staff Writer

Adding to its pipeline of bacteria-based therapeutic products, Osel Inc. obtained exclusive rights to develop and commercialize in the U.S. and Europe a product already approved in Japan.

Santa Clara, Calif.-based Osel signed a definitive in-licensing agreement for MIYA-BM, an oral drug developed by Japan-based Miyarisan Pharmaceutical Co. Ltd., for treating C. difficile-associated disease (CDAD) and antibiotic-associated diarrhea (AAD). The product, which has been available in Japan for about 30 years, has years of safety and efficacy data behind it, Osel President Ralph Levy said.

"Hopefully, we'll be able to go directly into Phase III trials after" filing an investigational new drug application, he said, adding that the IND submission is anticipated for the third quarter, followed by pivotal trials, first in the U.S., then in Europe.

Financial terms of the deal were not disclosed, but Levy told BioWorld Today that Osel would make "reasonable" milestone payments, as well as royalty payments, pending marketing approval.

The addition of MIYA-BM adds a second product to Osel's clinical pipeline, and looks to become the company's lead product. Its active ingredient is a strain of Clostridium butyricum, which has been shown to prevent and treat antibiotic-induced gastrointestinal disorders. The product also expresses butyric acid, which has been known to benefit mucosal linings, Levy said.

"It can also be used in combination," he noted, adding that the Japanese company, and now Osel, has a patent for MIYA-BM in combination with the antibiotic vancomycin, "which could produce a second-generation product in the future."

Levy said there is a fairly large market for the drug, and Osel eventually could see U.S. and European product sales totaling as much as $1 billion.

"There's no true intervention right now for AAD and CDAD," he said. "Though vancomycin and metronidazole are approved for those indications, they are antibiotics, which actually help cause the indications."

According to Osel, the incidence of AAD ranges from 3.2 to 29 per 100 hospitalized patients per year, adding anywhere from eight to 20 additional days to hospital stays and increasing the risk of acquiring other nosocomial infections. While the existing antibiotics might be able to kill the toxigenic C. difficile, they also disrupt the protective gut flora.

Levy added that it is not just hospitalized patients at risk for AAD, but for "any patients taking antibiotics for their conditions."

MIYA-BM complements Osel's other developing products, all based on the use of live bacteria to treat disease. The company's product stemming from the naturally occurring Lactobacillus cristatus bacteria, Lactin-V, is about to begin Phase II trials in recurrent urinary tract infection and recurrent bacterial vaginosis. The product is designed to act on vaginal mucosa to inhibit disease.

Osel gained rights to Lactin-V from The Medicines Co., of Parsippany, N.J.

Osel was founded in 1998 by Peter Lee, a cancer immunologist who serves as acting chairman and owns patents in genetically engineered bacteria. Levy said the company has programs working on those genetically engineered bacteria, as well as other programs focusing on Lactobacillus jensenii, which is producing second-generation HIV inhibitors, CD4 and cinovarin-N. Osel has 12 employees, including two who work at the manufacturing facility in Colorado.

Levy said the company has raised about $15 million to date, with funds coming from private investors and grants.