SANTA CLARA, Calif., March 2 /PRNewswire/ -- Osel, Inc., the Bacterio-Therapeutics company, has signed a definitive in-licensing agreement for MIYA-BM(R), an oral therapeutic drug product from Miyarisan Pharmaceutical Company, Ltd. of Japan. Osel has exclusive rights to commercialize the product in North America and Europe.
MIYA-BM(R), an oral tablet, was approved by the Japanese Ministry of Health, Labor and Welfare, for the indications of C. difficile associated disease (CDAD) and the larger market of antibiotic associate diarrhea (AAD). "This product complements our current portfolio of drug product candidates as it is also a comensal live bacterial product for the treatment of infections for which no optimal treatment exists today. Billions of dollars are expended in the treatment and extended hospital stays resulting from these infections," said Osel president, Ralph Levy.
The active ingredient is a specific, proprietary strain of C. butyricum, which has been shown to prevent as well as treat, the antibiotic-induced gastrointestinal disorders, AAD and CDAD. It has been used safely and effectively in thousands of patients, from pediatric to geriatric, for these indications for years in other countries, including Japan. The product is manufactured by a proprietary process at Miyarisan's state-of-the-art biological manufacturing facility located in Nagano, Japan.
"It is a privilege to work with Miyarisan, a well organized and extremely professional organization, in the commercialization of this product to solve this unmet medical need in the large North American and European markets." said Mr. Levy. Osel is planning pivotal clinical trials first in the U.S. and then in Europe, and is currently designing the clinical trial protocol for these studies. "This agreement works very much in the strategic interest of our two companies, and after regulatory approval will enable MIYA-BM(R) to be effectively used in other major markets," said Masayuki Uchida, Miyarisan's president.
The incidence of AAD ranges from 3.2 to 29 per 100 hospitalized patients per year. AAD typically extends patients' hospital stays 8 to 20 days, resulting in higher medical care costs and a higher risk of acquiring other types of nosocomial infections. Treatment for AAD is limited because there are no approved therapies available apart from discontinuation of the inciting antibiotic and supportive care. Discontinuation of antibiotic therapy is effective in only 15% of patients. Toxigenic C. difficile is responsible for 20% to 30% of AAD cases. This organism is the cause of pseudomembranous colitis, a potentially life threatening condition, and the most common intestinal tract infection in adult hospitalized patients. Diarrhea and colitis of CDAD are mediated by two toxins produced by toxigenic C. difficile strains. CDAD is currently treated with metronidazole or vancomycin. Although these antibiotics effectively kill C. difficile, they also disrupt the protective gut flora. Recurrence of CDAD from re-infection with C. difficile is a major medical problem in the hospital setting, and occurs in 15% to 20% of patients within 30 days of discontinuing antibiotic therapy.
Osel, Inc. is the leading company in the emerging field of Bacterio-Therapeutics. The company's business is based on exploiting recent scientific discoveries demonstrating the central role of naturally occurring mucosal bacteria in the maintenance of health and the prevention of disease. Osel's mission is to harness the protective properties of these specialized non-pathogenic bacteria as a basis for a series of innovative products initially targeted for the prevention and treatment of diseases of the genitourinary and gastrointestinal tracts.
Ralph Levy President, Osel Inc.
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