New Data Show Doripenem as Effective as Commonly Used Therapies in Treating Hospital-Acquired Pneumonias

CHICAGO -- Johnson & Johnson Pharmaceutical Research & Development, LLC  announces that the investigational antibiotic doripenem was found to clinically cure 81 percent of patients with nosocomial pneumonia (NP), and 68 percent of patients with ventilator-associated pneumonia (VAP) in studies comparing doripenem to commonly used therapies. These new data were presented in both oral and poster sessions at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Doripenem belongs to a class of antibacterial agents called carbapenems, which are useful in treating serious life-threatening infections caused by gram-negative and gram-positive bacteria. Doripenem is licensed from Shionogi & Co., Ltd., which launched the product in Japan in September 2005.

Nosocomial pneumonia is acquired in either a hospital or other healthcare setting and typically manifests at least 48 hours after admission. Ventilator-associated pneumonia is a form of nosocomial pneumonia which occurs in people who are on mechanical ventilation because they cannot breathe on their own. Pseudomonas aeruginosa, a Gram-negative pathogen with increasing multi-drug resistance, is one of the leading causes of nosocomial infections, including nosocomial pneumonia. According to the Centers for Disease Control and Prevention (CDC), 2 million Americans develop hospital-acquired infections each year, and approximately 90,000 die as a result. Approximately 70 percent of these infections are resistant to at least one antibiotic.

Data presented in an oral presentation demonstrated that 500 mg of doripenem administered intravenously every eight hours (500 mg IV q8h) was as effective and well tolerated as the standard combination of 4.5 g of piperacillin/tazobactam administered intravenously every six hours (4.5 g IV q6h) in patients with nosocomial pneumonia. In clinically evaluable patients, doripenem demonstrated an 81.3 percent clinical cure rate compared to a 79.8 percent cure rate seen with the combination of piperacillin/tazobactam. The study also highlighted that resistance to piperacillin/tazobactam in bacteria causing pneumonia was higher than doripenem, especially among strains of Pseudomonas aeruginosa and Klebsiella pneumoniae.

A second study demonstrated that 500 mg of doripenem administered intravenously every eight hours (500 mg IV q8h) was as clinically effective and well tolerated as standard therapy with imipenem given as 500 mg intravenously every six hours (500 mg IV q6h) or 1 g every eight hours (1 g IV q8h) in patients with ventilator-associated pneumonia, including in high-risk patients, such as the elderly. Overall clinical cure rates were 68.3 percent for doripenem and 64.8 percent for imipenem. For those patients with Pseudomonas aeruginosa infection, doripenem demonstrated a 65 percent clinical cure rate compared to a 36 percent clinical cure rate seen with imipenem.

"These studies demonstrate that doripenem may be effective against a major cause of nosocomial pneumonia, Pseudomonas aeruginosa, which is one of the most difficult bacteria to treat," said Michael Niederman, MD, professor of medicine at State University of New York at Stony Brook and chairman of the Department of Medicine at Winthrop University Hospital in Mineola, N.Y. "Additionally, these troubling bacteria demonstrated a low rate of resistance to doripenem, which is an important factor in determining which antibiotic may work most effectively against the infection."

The use of doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, is under standard regulatory review in the United States and Europe. These data, along with the regulatory submissions, demonstrate the ongoing commitment of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., to developing novel drugs for the anti-infective market.

Source:  Johnson & Johnson Pharmaceutical Research & Development, LLC