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.
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
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
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