Enanta Pharmaceuticals Achieves Milestone in Collaboration with Shionogi & Co., Ltd., as Phase 1 Studies Initiate in Japan on EP-013420, a First-In-Class Bridged Bicyclic Ketolide Antibiotic

Mar 14, 2005, 00:00 ET from Enanta Pharmaceuticals

    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
     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
     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