DoribaxTreatment for Intraabdominal Infection, Urinary Tract Infection
Update: Doribax Now FDA Approved - October 12, 2007
New Drug Application Submitted for Investigational Antibiotic Doripenem
RARITAN, N.J., June 06, 2007 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for doripenem, an investigational carbapenem antibiotic for the treatment of nosocomial pneumonia, a pneumonia that is acquired in a hospital or other healthcare setting.
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 percent of these infections are resistant to at least one antibiotic. Pneumonia is the second, most-common, hospital-acquired infection in the United States and is associated with substantial morbidity and mortality.
Doripenem belongs to a class of antibacterial agents called carbapenems, which are useful in treating life-threatening infections caused by Gram-negative(1) and Gram-positive(2) bacteria. The data supporting the NDA showed doripenem was an effective treatment for hospital-acquired pneumonia. The data also demonstrated the effectiveness of doripenem against infections caused by Gram-negative bacteria, such as Pseudomonas aeruginosa and Enterobacteriaceae, including strains of these bacteria that are resistant to other therapies.
Pseudomonas aeruginosa is one of the leading causes of hospital-acquired infections and, because of increasing multi-drug resistance, treatment options are limited. In general, there are few antibiotics available or currently in development to treat the resistant infections - which can be potentially life-threatening - associated with these Gram-negative bacteria.
In clinical trials, doripenem was well-tolerated. The most common treatment-emergent adverse events seen were diarrhea, nausea, constipation, urinary tract infection and decubitus ulcer, commonly known as a bedsore.
The nosocomial pneumonia indication for doripenem had been granted "fast-track" status by the FDA. An NDA for the treatment of complicated intra-abdominal and complicated urinary tract infections was submitted to the FDA in December 2006. These submissions demonstrate the ongoing commitment of J&JPRD and its affiliate, Ortho-McNeil, Inc., to developing novel drugs for the anti-infective market. Pending regulatory approval, doripenem will be marketed in the United States by Ortho-McNeil, Inc. Doripenem is licensed from Shionogi & Co., Ltd., which launched the product in Japan in September 2005.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., 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 and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
Ortho-McNeil, Inc. is committed to providing innovative, high-quality prescription medicines, education and resources for patients, healthcare providers, and other members of the healthcare community in primary care, specialty and hospital settings. Based in Raritan, NJ, the company specializes in the areas of gastrointestinal and infectious diseases, pain management, women's health and urology, and has broad interest in other therapeutic categories. For more information, visit www.ortho-mcneil.com.
[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 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.]
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(1) 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 composition of their cell walls and is used to identify the type of bacteria. Some Gram-negative bacteria may cause serious infections.
(2) Gram-positive indicates a group of bacteria that become violet-colored when the bacterial cells are treated with the Gram stain. This response is based on the chemical composition 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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Posted: June 2007
- FDA Approves Doribax for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections - October 15, 2007
- New Drug Application Submitted for Investigational Antibiotic Doripenem - December 15, 2006