ceftobiproleTreatment for Skin and Structure Infection
New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole
RARITAN, N.J., May 18, 2007 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) announced today that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for ceftobiprole, an investigational antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections, in adults.
In clinical trials, ceftobiprole demonstrated high cure rates in patients with complicated skin infections, including the potentially deadly "super bug," methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole has been granted "fast-track" status from the FDA and is licensed from, and is being co-developed with, Basilea Pharmaceutica Ltd. through an exclusive worldwide collaboration.
Staphylococcus aureus is the predominant bacteria associated with skin infections. According to the Centers for Disease Control and Prevention, approximately 25 to 30 percent of the U.S. population carries some form of Staphylococcus aureus and many of those individuals carry MRSA, a bacteria that is highly resistant to most currently available antibiotics. The rate of MRSA within Staphylococcus aureus infections in U.S. hospitals doubled from 30 percent in 1992 to more than 60 percent in 2003 and reports of outbreaks have been increasing among healthy individuals outside the hospital, creating a growing public health concern.
Ceftobiprole belongs to a class of antibacterial agents known as cephalosporins, which are used to treat serious infections such as Gram-negative and Gram-positive infections. The Phase III data supporting the NDA showed that ceftobiprole demonstrated broad-spectrum coverage in serious infections including diabetic foot infections, but unlike currently available cephalosporins, ceftobiprole exhibited activity against MRSA. In the trials, ceftobiprole was well tolerated with common treatment-emergent adverse events, including nausea, taste disturbance, diarrhea and vomiting.
The NDA submission of ceftobiprole demonstrates the ongoing commitment of J&JPRD and its affiliate, Ortho-McNeil, Inc., to developing novel drugs for the anti-infective market. Pending regulatory approval, ceftobiprole will be marketed in the United States by Ortho-McNeil, Inc., and Basilea Pharmaceutica Ltd.
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.]
For more information on Johnson & Johnson, please visit the Company's web site at www.jnj.com.
CONTACT: Media Contacts, Amy Firsching, +1-908-218-7583, or Samina Bari,+1-908-218-6483, or IR Contacts, Stan Panasewicz, +1-732-524-2524, LesleyFishman, +1-732-524-3922, or Louise Mehrotra, +1-732-524-6491, all ofJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Web site: http://www.jnj.com/
Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: May 2007
- FDA Issues Complete Response Letter for Ceftobiprole - December 30, 2009
- FDA accepts for review the Complete Response submission to ceftobiprole NDA - September 3, 2009
- FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections - November 26, 2008
- FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter - September 15, 2008
- FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections - March 18, 2008
- FDA Published Today That It Will Not Hold an Advisory Committee Meeting on Ceftobiprole in the Treatment of Complicated Skin and Skin Structure Infections - February 13, 2008
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting - January 10, 2008
- U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin - July 18, 2007