-- Phase 2 Studies Initiated in Japan on First-in-Class Antibiotic EDP-420
(S-013420) for the Treatment of Community Acquired Pneumonia --
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
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. 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.
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 Biomedical
Communications:
Kari Watson
(508) 647-0209
kwatson@macbiocom.com
SOURCE Enanta Pharmaceuticals
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Related links:
http://www.enanta.com
http://www.shionogi.co.jp
CONTACT:
Paul Mellett, Senior Vice President and Chief
Financial Officer of Enanta Pharmaceuticals, +1-617-607-0761,
pmellett@enanta.com; or Kari Watson of MacDougall Biomedical
Communications, +1-508-647-0209, kwatson@macbiocom.com
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