The U.S. Food and Drug
Administration (FDA) has approved DORIBAX(TM) (doripenem for injection) as
a new treatment for complicated intra-abdominal and complicated urinary
tract infections, including pyelonephritis. DORIBAX has demonstrated
activity against a wide range of Gram-positive(1) and Gram-negative(2)
bacteria — including Pseudomonas — that cause these serious infections.

DORIBAX belongs to a class of antibacterial agents called carbapenems,
which are important for treating serious infections caused by Gram-positive
and Gram-negative bacteria.

The approval of DORIBAX is based on results of clinical trials in
complicated intra-abdominal infections (cIAI) and complicated urinary tract
infections (cUTI). In two multi-center, prospective, randomized,
double-blind studies, DORIBAX was found to be effective and well tolerated
for the treatment of complicated intra-abdominal infections. In another
multi-center, randomized, double-blind study and an additional single-arm,
multi-center study, DORIBAX was found to be effective and well tolerated
for the treatment of complicated urinary tract infections.

DORIBAX was effective against major organisms that cause cIAI and cUTI,
including E. coli, B. fragilis, viridans group streptococci, Proteus
species, K. pneumoniae and Pseudomonas aeruginosa.

Pseudomonas aeruginosa, a Gram-negative bacterium with increasing
multi-drug resistance, is one of the leading causes of hospital-acquired
(nosocomial) infections. In general, there are few antibiotics available or
in development to treat these life-threatening Gram-negative infections.

“New agents are urgently needed to effectively treat Gram-negative and
Gram-positive bacterial infections,” said Joseph Solomkin, M.D., Professor
of Surgery and Director of Research, University of Cincinnati College of
Medicine. “The introduction of DORIBAX is important for the treatment of
these serious infections as fewer antibiotics appear to effectively
eradicate many troublesome bacteria, such as Pseudomonas.”

Approximately two million intra-abdominal procedures are performed in
the U.S. each year. Complicated intra-abdominal infections are infections
that extend beyond the hollow cavity of the abdomen into the peritoneal
space and are a common cause of hospitalization following these procedures.

Urinary tract infections (UTIs) account for at least 40% of all
hospital infections. Although many cases of UTI are uncomplicated, a
significant proportion of UTIs are classified as complicated because of
anatomical abnormalities in the urinary tract, which make clearance of
bacteria more difficult, or cause kidney infection (pyelonephritis).
Complicated UTIs can be caused by a broad range of bacteria, many of which
are resistant to multiple antibiotics.

DORIBAX will be marketed to U.S. hospitals and other healthcare
institutions by Ortho-McNeil, Inc. through its Institutional Franchise. The
use of doripenem in the treatment of hospital-acquired (nosocomial)
pneumonia, including ventilator-associated pneumonia, is under regulatory
review in the U.S., and the use of doripenem for complicated
intra-abdominal infections, complicated urinary tract infections and
nosocomial pneumonia, including ventilator-associated pneumonia, is under
regulatory review in Europe. Doripenem is licensed from Shionogi & Co.,
Ltd., which launched the product in Japan in September 2005 under the name,
FINIBAX.

INDICATIONS

DORIBAX is indicated as a single agent for the treatment of:
complicated intra-abdominal infections caused by susceptible strains of E.
coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B.
thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S.
constellatus or P. micros and for the treatment of complicated urinary
tract infections, including pyelonephritis, caused by susceptible strains
of E. coli, including cases with concurrent bacteremia, K. pneumoniae, P.
mirabilis, P. aeruginosa, or A. baumannii.

To reduce the development of drug-resistant bacteria and maintain the
effectiveness of DORIBAX and other antibacterial drugs, DORIBAX should be
used only to treat infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility information
are available, they should be considered in selecting and modifying
antibacterial therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of therapy.

IMPORTANT SAFETY INFORMATION

DORIBAX is contraindicated in patients with known serious
hypersensitivity to doripenem or other carbapenems or in patients who have
demonstrated anaphylactic reactions to beta-lactams.

Serious and occasionally fatal hypersensitivity (anaphylactic) and
serious skin reactions have been reported in patients receiving beta-lactam
antibiotics. These reactions are more likely to occur in individuals with a
history of sensitivity to multiple allergens. If an allergic reaction to
DORIBAX occurs, discontinue the drug. Serious acute anaphylactic reactions
require emergency treatment with epinephrine and other emergency measures,
including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor
amines and airway management, as clinically indicated.

Carbapenems may reduce serum valproic acid concentrations to
subtherapeutic levels, resulting in loss of seizure control. Serum valproic
acid concentrations should be monitored frequently after initiating
carbapenem therapy. Alternative antibacterial or anticonvulsant therapy
should be considered if serum valproic acid concentrations cannot be
maintained in the therapeutic range or seizures occur.

Clostridium difficile-associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents and may range in severity from mild
diarrhea to fatal colitis. CDAD must be considered in all patients who
present with diarrhea following antibiotic use. Careful medical history is
necessary since CDAD has been reported to occur over two months after
administration of antibacterial agents. If CDAD is suspected or confirmed,
ongoing antibiotic use not directed against C. difficile may need to be
discontinued.

When doripenem has been used investigationally via inhalation,
pneumonitis has occurred. DORIBAX should not be administered by this route.

Safety and effectiveness in pediatric patients have not been
established.

The most common adverse reactions (greater than or equal to 5%)
observed in clinical trials were headache, nausea, diarrhea, rash and
phlebitis.

Ortho-McNeil, Inc.

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. Headquartered in Raritan, N.J., the
company markets products for infectious diseases, gastrointestinal
disorders, pain management, women’s healthcare and urology. For more
information, visit ortho-mcneil.

[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
sec or on request from Johnson & Johnson. 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 jnj.

References

(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 and physical properties 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 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.

Ortho-McNeil, Inc.
ortho-mcneil

View drug information on Doribax.