Washington Editor

Enanta Pharmaceuticals Inc. and Shionogi & Co. Ltd. entered a deal for the development and commercialization of EP-013420, Enanta's first-in-class Bridged Bicyclic Ketolide antibiotic for the treatment of community respiratory tract infections.

Through the agreement, Shionogi, of Osaka, Japan, gained rights in Japan and certain East Asian countries.

Financial terms were not released, but Jay Luly, president and CEO of Watertown, Mass.-based Enanta, told BioWorld Today Enanta received an up-front cash payment and an equity investment.

In addition, Enanta could receive pre-commercialization payments for the successful development of EP-013420, an early stage candidate, and its backup compound. Luly said the agreement includes "significant" milestones and "good" royalties. The terms are within the range commonly found in the industry for an early clinical-stage program with blockbuster potential, Luly said. (The global respiratory antibiotic market was about $12 billion in 2002, Enanta said.)

For Enanta, the deal validates its expertise in the antibiotic arena, Luly said, adding that Shionogi is the Asian leader in antibiotic marketing.

Enanta expects to start Phase I trials on EP-013420 later this summer.

As a community respiratory tract infection candidate, EP-013420 potentially could treat community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, tonsilitis/pharyngitis and otitis media. EP-013420 was discovered by Enanta.

Preclinical studies have shown an excellent pharmacokinetic profile and an improved activity profile relative to currently marketed macrolides and ketolides, including against many strains of resistant S. pneumoniae, the company said.

S. pneumoniae is the most commonly implicated bacteria in respiratory infections, responsible for 45 percent of the cases of community-acquired pneumonia and 34 percent of acute sinusitis. Nearly one-third of S. pneumoniae infections in the U.S. are resistant to penicillin and 31 percent are resistant to the macrolide antibiotic erythromycin. S. pneumoniae resistance is more common in Asia, where 53 percent of S. pneumoniae infections are penicillin resistant and 80 percent are erythromycin resistant.

Privately held Enanta expects to bring on a second partner for areas outside the Shionogi jurisdiction. Because Phase III programs are exceptionally large for community antibiotics, Luly hopes to have another partner before such a program begins.

Meanwhile, Enanta has an ongoing deal with Chiron Corp., of Emeryville, Calif., for the development of drugs for the hepatitis C virus. Under the agreement, Enanta is using its macrocyclic and medicinal chemistry expertise to help Chiron identify potential drug candidates. (See BioWorld Today, Sept. 5, 2002.)

Since it was founded in 1998, Enanta has raised about $57 million.