FDA Requires Additional Information on DORIBAX for Treatment of Hospital-Acquired Pneumonia

    RARITAN, N.J., Aug. 21 /EMWNews/ -- Johnson & Johnson Pharmaceutical

Research & Development, L.L.C. (J&JPRD) today announced that the U.S. Food

and Drug Administration (FDA) requires additional information before it

will approve the company's New Drug Application (NDA) for DORIBAX(TM)

(doripenem for injection) for the treatment of hospital-acquired pneumonia,

also known as nosocomial pneumonia (NP), including ventilator-associated

pneumonia (VAP).



    In response to the J&JPRD application seeking approval for DORIBAX for

the additional indication of the treatment of NP, including VAP, the FDA

issued a Complete Response letter outlining the actions necessary to

address outstanding issues.



    J&JPRD is reviewing the agency's letter and will work to resolve any

outstanding questions. The NDA for DORIBAX for the treatment of NP,

including VAP, was submitted to the FDA in June 2007.



    The NDA for DORIBAX for the treatment of NP, including VAP, was the

subject of a July 16, 2008 U.S. Food and Drug Administration Anti-Infective

Drugs Advisory Committee. Based on data presented from two large nosocomial

pneumonia trials, the committee voted that 500 mg of DORIBAX at both the

one-hour and four-hour infusion regimens were safe (8-5) and effective

(7-6) in the treatment of NP, including VAP. The committee did not agree

that the non-inferiority margin for the DORIBAX NP trials was appropriately

justified, nor did it agree on the appropriate margin for NP trials in

general. J&JPRD is confident in the NP data submitted and will work with

the FDA to address the issues raised in the Complete Response letter.



    DORIBAX is an intravenous (IV) antibiotic for hospital use, and belongs

to a class of antibacterial drugs called carbapenems. Carbapenems are

important antibiotics to treat serious -- and sometimes life-threatening --

infections caused by a broad range of bacteria, which are characterized as

Gram-negative and Gram-positive, based on a classification process that is

used to identify the specific type of bacteria.



    DORIBAX was approved in the U.S. in October 2007 for the treatment of

complicated intra-abdominal infections (cIAI) and complicated urinary tract

infections (cUTI), including pyelonephritis, due to susceptible bacteria,

and is marketed by Ortho-McNeil, Division of Ortho-McNeil-Janssen

Pharmaceuticals, Inc. DORIBAX also is approved in Europe and Russia for

cIAI, cUTI and NP, including VAP. Doripenem is licensed from Shionogi &

Co., Ltd.



    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 (2) 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 DORIBAX 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.



    Please see the DORIBAX Full Prescribing Information by visiting

http://www.DORIBAX.com



    Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.,

is committed to providing innovative, high-quality prescription medicines

and resources in the areas of bacterial infection and cardiovascular

disease for healthcare providers and their patients in hospitals and other

care facilities. For more information, visit http://www.ortho-mcneil.com.



    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 Asia, Europe and the U.S. J&JPRD is leveraging drug

discovery and drug development in a variety of therapeutic areas to address

unmet medical needs worldwide.



    FORWARD LOOKING STATEMENT



    (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 30, 2007. Copies of

this Form 10-K, as well as subsequent filings, are available online at

http://www.sec.gov, http://www.jnj.com 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.)






    CONTACTS:

    Media: Amy Firsching, 908-218-7583 or Greg Panico, 908-927-3715

    Investor Relations: Lesley Fishman, 732-524-3922 or

     Louise Mehrotra, 732-524-6491