Enanta Pharmaceuticals, Inc. Achieves Milestone In Alliance With Shionogi & Co., Ltd.
WATERTOWN, Mass., Dec. 20 /PRNewswire/ -- Enanta Pharmaceuticals today announced that it has received a milestone payment from its East Asia development and commercialization partner, Shionogi & Co., Ltd., as Phase 2 studies have initiated in Japan for its community antibiotic, EDP-420 (formerly known as EP-013420, and known in Japan as S-013420).
Results of the Phase 1 trials in Japan showed that EDP-420 (S-013420) was generally well tolerated and possessed favorable pharmacokinetic properties. In addition, attractive drug levels in the lung were observed in healthy volunteers, supporting the evaluation of EDP-420 (S-013420) for the treatment of respiratory tract infections.
"The development activities of EDP-420 (S-013420) in Japan have progressed rapidly since the announcement of our partnership with Shionogi in the summer of 2004, as indicated by Shionogi's successful IND submission, completion of Phase 1, and now Phase 2 start," said Jay Luly, Ph.D., President and CEO of Enanta Pharmaceuticals. "We are delighted to advance our partnership with Shionogi, the established antibiotic leader in Japan, and to progress the global development of this important antibiotic together."
"Shionogi is very pleased to announce the initiation of Phase 2 studies of S-013420 in Japan. This marks an important milestone in our alliance with Enanta, and demonstrates Shionogi's commitment to steadfastly developing novel antibiotics that treat resistant bacterial infections that address important unmet medical needs in our communities," said Motozo Shiono, President of Shionogi.
About EDP-420 (S-013420)
Enanta is developing EDP-420 (S-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. EDP-420 (S-013420) is a first-in- class Bridged Bicyclic Macrolide 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 EDP-420 (S-013420) and an improved activity profile relative to currently marketed macrolides and ketolides, including 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 $4 billion in 2003. Macrolides alone represented almost 20% percent of the total antibiotic sales in 2000 and are expected to retain this share over time.
About Shionogi & Co., Ltd.
Shionogi & Co. Ltd. is a major research-driven Japanese pharmaceutical manufacturer. The company's primary businesses are research and development, manufacturing, marketing, and import and export sales of pharmaceutical and diagnostics products. Shionogi follows a basic policy of continually providing the superior medicines essential to people's health. For more details, please visit http://www.shionogi.co.jp
Enanta Pharmaceuticals is a research and development company, which 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 successfully integrates chemistry with biology and medicine, in order to discover and develop novel small molecules that address the following significant, unmet medical needs: a new class of macrolide and ketolide antibiotics to overcome bacterial resistance and 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.
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Source: Enanta Pharmaceuticals