Ramoplanin

In December 2009, Nanotherapeutics, Inc. acquired Ramoplanin from Oscient Pharmaceuticals Corporation. Ramoplanin, an oral antibiotic for the treatment of Clostridium difficile-associated disease (CDAD), is entering Phase 3 trials. Nanotherapeutics also acquired the U.S. and foreign patent estates covering the clinical program.

CDAD ranges from uncomplicated diarrhea in its mildest form, to fulminant colitis and death, in its most severe form. CDAD was previously mainly a concern in older or severely ill patients who were hospital inpatients or residents of long-term--care facilities. In recent years, the incidence and severity of CDAD has increased with the emergence of virulent strains creating a growing unmet need. In addition to the U.S., many countries have reported rising numbers of CDAD cases, including Australia, Canada, and the United Kingdom. Currently, it is estimated that 400,000 - 500,000 cases of CDAD occur each year in the U.S., with the incidence apparently doubling from 1996 to 2003, including a five-fold increase in those 65 and older. The disease generates in excess of $2.8 billion in hospital health care costs annually in the U.S.

Ramoplanin has been shown to be bactericidal in vitro against C. difficile and other gram positive bacteria and showed safety and efficacy through Phase 2. Because it is not absorbed systemically from the gastrointestinal tract following oral dosing and exerts its bactericidal activity locally in the GI tract, Ramoplanin represents a potential new method for managing certain pathogens commonly found in the hospital. The FDA approved a Special Protocol Assessment non-inferiority trial against vancomycin for Phase 3.