Enanta Pharmaceuticals and Shionogi & Co., Ltd. Sign Agreement for Development and Commercialization of the First-in-Class Bridged Bicyclic Ketolide Antibiotic EP-013420 in Japan and East Asian Countries

    WATERTOWN, Mass., July 27 /PRNewswire/ -- Enanta Pharmaceuticals today
 announced that Enanta and Shionogi & Co., Ltd. (Osaka, Japan) have entered
 into an agreement to develop and commercialize EP-013420, Enanta's first-in-
 class Bridged Bicyclic Ketolide antibiotic for the treatment of community
 respiratory tract infections, in Japan and certain East Asian countries.
 Enanta will retain exclusive development and marketing rights to EP-013420 in
 the rest of the world, including North America and Europe.  Enanta plans to
 report the initiation of Phase 1 clinical trials on EP-013420 later this
 summer.
     Under the terms of the agreement, Enanta received an upfront cash payment
 and an equity investment.  In addition, Enanta could receive pre-
 commercialization payments for the successful development of EP-013420 and its
 back-up compound. Enanta will also receive royalties on product sales by
 Shionogi.  The financial terms, while not disclosed, are within a range
 commonly found in the industry for an early clinical stage program with
 blockbuster potential.
     Jay Luly, Ph.D., President and CEO of Enanta said, "This regional
 partnership provides us with a superb pharmaceutical partner in Asia,
 recognizes the potential of EP-013420 as a breakthrough community respiratory
 antibiotic and allows Enanta to retain the development and marketing rights in
 the rest of the world."
     "Antibiotic resistance in the community is a serious public health concern
 around the world, and it is important that we continue to develop promising
 new antibiotics, such as EP-013420, which is effective against such resistant
 strains," said Motozo Shiono, President of Shionogi.  "Partnering with
 innovative biotechnology companies in the United States is an important
 strategy for Shionogi, and our alliance with Enanta is consistent with this
 goal."
     "Shionogi is the premier antibiotic company in Japan and has a prolific
 history of commercializing antibiotics, including Flomox(TM)," said Yujiro
 Hata, Vice President, Business Development of Enanta. "This alliance advances
 our corporate strategy to ensure the successful development and
 commercialization of EP-013420 worldwide with the leaders in the antibiotic
 field."
 
     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 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 $5.6 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
     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, which uses
 its novel chemistry approach and drug discovery capabilities to create best in
 class small molecule drugs in the anti-infective field.  At the heart of
 Enanta is its commitment to innovative chemistry that surpasses traditional
 medicinal chemistry approaches.  The Company successfully integrates chemistry
 with biology, 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.
 
      For Investor Relations, please contact:
      Paul Mellett
      Senior Vice President and Chief Financial Officer
      (617) 607-0761
      pmellett@enanta.com
 
      For Public Relations, please contact MacDougall Biocommunications:
      Kari Lampka
      (508) 647-0209
      kari@macbiocom.com
 
 

SOURCE Enanta Pharmaceuticals

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