WATERTOWN, Mass., March 14 /PRNewswire/ -- Enanta Pharmaceuticals today announced that it has received a milestone payment from its EP-013420 East Asia development and commercialization partner, Shionogi & Co. Ltd. The milestone reflects the initiation of Phase 1 studies Japan for the community antibiotic, which has been renamed S-013420 by Shionogi & Co. Ltd, for development in East Asia. First in class, EP-013420 is a Bridged Bicyclic Ketolide (BBK) that was designed by Enanta to have optimal pharmacokinetics and to provide broad treatment against respiratory pathogens, including several multi-drug resistant strains for which traditional macrolides, penicillins, and fluoroquinolones are no longer effective. Enanta initiated a Phase 1 clinical trial for EP-013420 in the United States in August 2004. In this Japanese trial, EP-013420 will be evaluated for its pharmacokinetics, safety and tolerability in healthy volunteers. In the summer of 2004, Enanta exclusively licensed the East Asian territory rights for EP-013420 to Shionogi & Co., LTD., of Osaka, Japan. "This milestone in our alliance with Shionogi represents an important achievement for both our companies, as it demonstrates the progress we have made as partners toward advancing the development of EP-013420 worldwide," said Jay Luly, Ph.D., President and CEO of Enanta Pharmaceuticals. "Shionogi is very pleased to announce the initiation of Phase I studies of S-013420 in Japan. As bacterial resistance continues to be a major health concern around the world, it is important that we continue to develop new antibiotics, such as S-013420, that help treat such drug-resistant bacteria in the community setting. The initiation of Phase I studies in Japan marks progress on our corporate goal to meet this global unmet medical need," said Motozo Shiono, President of Shionogi. About EP-013420 Enanta is developing EP-013420 for the treatment of community respiratory tract infections with potential indications for community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, tonsilitis/pharyngitis, and otitis media. EP-013420 is a first-in-class Bridged Bicyclic Ketolide antibiotic that is the result of Enanta's innovative medicinal chemistry approach to creating novel and proprietary chemical structures. Preclinical studies have shown an excellent pharmacokinetic profile for EP-013420 and an improved activity profile relative to currently marketed macrolides and ketolides, including activity against many strains of resistant S. pneumoniae. This is the most commonly implicated bacteria in respiratory infections, responsible for 45% of the cases of community acquired pneumonia (CAP) and 34% of acute sinusitis. Nearly one-third of S. pneumoniae infections in the US are resistant to penicillin and 31% are resistant to the macrolide antibiotic erythromycin. S. pneumoniae resistance is more common in Asia, where 53% of S. pneumoniae infections are penicillin resistant and 80% are erythromycin resistant. The global respiratory antibiotic market was approximately $12 billion in 2002. Three major antibiotic classes dominate the respiratory antibiotic market: macrolides, beta-lactams, and quinolones. Of these classes, several respiratory antibiotics generate annual sales well in excess of $1 billion. Worldwide sales of macrolide drugs amounted to approximately $5.64 billion in 2003. About Shionogi Shionogi & Co., Ltd. is one of Japan's largest research based pharmaceutical companies: developing, manufacturing, distributing, importing and exporting pharmaceuticals and diagnostics. Shionogi's fundamental company policy is to constantly strive to provide medicine of the best possible kind essential for the protection of the health of people worldwide. For additional company information, please visit Shionogi on the World Wide Web at http://www.shionogi.co.jp. About Enanta Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the anti-infective field. The heart of Enanta is its commitment to innovative chemistry that surpasses traditional medicinal chemistry approaches. The Company's successful integration of chemistry with biology has created a new class of macrolide and ketolide antibiotics that overcome bacterial resistance. Additionally, Enanta has discovered antiviral agents targeted against the Hepatitis C virus (HCV). Enanta is a privately held company with offices in Watertown, MA. More information about the company can be found at http://www.enanta.com.
SOURCE Enanta Pharmaceuticals