FDA Advisory Committee Provides Opinion of DORIBAX(TM) for the Treatment of Hospital-Acquired Pneumonia

    RARITAN, N.J., July 16 /EMWNews/ -- Johnson & Johnson Pharmaceutical

Research & Development, L.L.C. announced today that the U.S. Food and Drug

Administration's (FDA) Anti-Infective Drugs Advisory Committee voted in

favor of the efficacy and safety data for DORIBAX(TM) (doripenem for

injection) for the treatment of hospital-acquired pneumonia, or nosocomial

pneumonia (NP), and ventilator-associated pneumonia (VAP).



    The committee voted that 500 mg of DORIBAX at both the one-hour and

four-hour infusion regimens was safe (8-5) and effective (7-6). The

committee did not agree on the appropriate non-inferiority margins for

anti-infectives trials in nosocomial pneumonia.



    The independent Advisory Committee provides recommendations based on

its evaluation of the information presented. However, the final decision

regarding approval of the drug is made by the FDA.



    "We recognize that there is an important need for new antibiotics to

treat these serious hospital infections," said Joanne Waldstreicher, M.D.,

Global Head, Drug Development, Johnson & Johnson Pharmaceutical Research &

Development, L.L.C. "We look forward to further discussions with the FDA as

they complete their review of DORIBAX for the treatment of

hospital-acquired and ventilator-associated pneumonia."



    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 is approved in the U.S. 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. The use of DORIBAX for the treatment of NP, including VAP, is under

regulatory review in the U.S. DORIBAX received a positive opinion from the

Committee for Medicinal Products for Human Use (CHMP) and is awaiting final

approval in Europe 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.

(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.






    Media Contacts: Amy Firsching, 908-218-7583 or

                    Samina Bari, 908-218-6483



    IR Contacts:    Lesley Fishman, 732-524-3922 or

                    Louise Mehrotra, 732-524-6491