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New Data Show Doripenem as Effective as Commonly Used Therapies in Treating Hospital-Acquired Pneumonias
Date:9/18/2007

CHICAGO, Sept. 18 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C., today announced that the investigational antibiotic doripenem was found to clinically cure 81% of patients with nosocomial pneumonia (NP), and 68% 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), two million Americans develop hospital-acquired infections each year, and approximately 90,000 die as a result. Approximately 70% 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% clinical cure rate compared to a 79.8% 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% for doripenem and 64.8% for imipenem. For those patients with Pseudomonas aeruginosa infection, doripenem demonstrated a 65% clinical cure rate compared to a 36% 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, M.D., Professor of Medicine, State University of New York at Stony Brook and Chairman of the Department of Medicine at Winthrop University Hospital in Mineola, New York. "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.

Study Results

In a Phase III, open-label, randomized, multi-center trial of 448 patients with nosocomial pneumonia (not associated with mechanical ventilation or early onset ventilator-associated pneumonia) were treated with either a one-hour IV infusion of 500 mg of doripenem every eight hours (500 mg q8h) or a 30-minute IV infusion of 4.5 g piperacillin/tazobactam administered every six hours (4.5 g q6h). After treatment with either therapy for at least 72 hours, subjects who met the criteria for clinical improvement were permitted to switch to 750 mg of oral levofloxacin, once a day (750 mg qd), to allow for hospital discharge. Cure rates in clinically evaluable patients were 81.3% (doripenem) and 79.8% (piperacillin/tazobactam).

The study demonstrated that a greater proportion of bacteria were resistant to piperacillin/tazobactam compared with doripenem. Resistance rates to piperacillin/tazobactam and doripenem (doripenem resistance defined as a minimum inhibitory concentration (MIC) of greater than or equal to 16 mcg/mL) in patients with Pseudomonas aeruginosa were 27% vs. 4%, respectively and in patients with Klebsiella pneumoniae were 43% vs. 0%, respectively.

In a second large, open-label, randomized, multi-center trial, 531 patients with VAP and hospitalized in the Intensive Care Unit (ICU) were randomized to receive either a four-hour IV infusion of 500 mg of doripenem every eight hours (500 mg q8h) or an IV infusion of imipenem 500 mg four times a day or 1000 mg every eight hours (500 mg q6h or 1000 mg q8h for 30 or 60 minutes, respectively). At baseline, Pseudomonas aeruginosa isolates were less resistant to doripenem than imipenem (0% vs. 13% respectively, MIC of greater than or equal to 16 mcg/mL). Cure rates in clinically evaluable patients were similar for doripenem compared to imipenem (68.3% vs. 64.8%, respectively). Cure rates in the clinically modified intent-to-treat population were similar between doripenem and imipenem (59% vs. 57.8%, respectively).

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is part of Johnson & Johnson, the world's most broadly-based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov or on request from the Company. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.]

For more information on Johnson & Johnson, please visit the Company's web site at http://www.jnj.com.

* Gram-negative indicates a group of bacteria that become red when the

bacterial cells are treated using the Gram stain method. This

response is based on the chemical and physical properties of their

cell walls and is used to identify the type of bacteria. Some Gram-

negative bacteria may cause serious infections.

** Gram-positive indicates a group of bacteria that become blue when the

bacterial cells are treated with the Gram stain. This response is

based on the chemical and physical properties of their cell walls and

is used to identify the type of bacteria. Some Gram-positive bacteria

may cause serious infections.


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SOURCE Johnson & Johnson Pharmaceutical Research & Development,
L.L.C.
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