MEDIA RELEASE PR37717
FDA Issues Complete Response Letter for Ceftobiprole
RARITAN, N.J., Dec. 30 /PRNewswire-AsiaNet/ --
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
today announced it received a Complete Response letter from the U.S. Food and
Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA)
was originally submitted to the FDA in May 2007 for the treatment of
complicated skin and skin structure infections (cSSSI), including diabetic
foot infections.
The FDA has requested additional information and recommended additional
clinical studies be conducted in order to consider a future approval of
ceftobiprole in this indication. J&JPRD intends to discuss the best path
forward with the FDA as soon as possible.
Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica Ltd. in
February 2005. In March 2008, J&JPRD received an Approvable Letter regarding
the ceftobiprole filing. J&JPRD responded to the FDA's Approvable Letter in
August 2008. In November 2008, J&JPRD received a Complete Response letter,
which recommended additional site audits be conducted. The Company completed
those audits through a third party and included the results in its June 2009
response to the FDA's Complete Response letter.
About Ceftobiprole
Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with
activity against methicillin-resistant Staphylococcus aureus (MRSA),
penicillin-resistant Streptococcus pneumonia and many clinically important
Gram-negative bacteria, including Pseudomonas.
The regulatory review process is ongoing in Europe and other countries
for the use of ceftobiprole in adults for the treatment of complicated skin
and skin structure infections. Ceftobiprole is approved in Canada,
Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
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 Asia, 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.
[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 J&JPRD or Johnson & Johnson'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, 2008. Copies of this Form
10-K, as well as subsequent filings, are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. Neither J&JPRD nor Johnson
& Johnson undertakes to update any forward-looking statements as a result of
new information or future events or developments.]
CONTACTS:
Media: Ernie Knewitz, 908-927-2953 or Amy Firsching, 908-218-7583
Investor Relations: Louise Mehrotra, 732-524-6491
SOURCE: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
CONTACT: Media: Ernie Knewitz,
+1-908-927-2953
or Amy Firsching,
+1-908-218-7583,
or Investor Relations:
Louise Mehrotra,
+1-732-524-6491,
all of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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