FDA Advisory Committee Recommends Accelerated Approval of Investigational Multi-Drug Resistant Tuberculosis Treatment

  FDA Advisory Committee Recommends Accelerated Approval of Investigational
           Multi-Drug Resistant Tuberculosis Treatment Bedaquiline

PR Newswire

RARITAN, N.J., Nov. 28, 2012

RARITAN, N.J., Nov. 28, 2012 /PRNewswire/ --Janssen Research & Development,
LLC (Janssen) today announced that the Anti-Infective Drugs Advisory Committee
of the U.S. Food and Drug Administration (FDA), in a unanimous vote (18-0),
agreed that the efficacy findings forinvestigational bedaquiline support the
proposed indication for the treatment of pulmonary multi-drug resistant
tuberculosis (MDR-TB) as part of combination therapy in adults. The committee
agreed in a vote of 11-7 that the safety findings supported the proposed

"We are pleased with the committee's recommendation and look forward to
working with the FDA to bring this important therapy to patients who suffer
from MDR-TB," said Wim Parys, Global Head of Development, Infectious Diseases
and Vaccines, Janssen. "The positive recommendation from the FDA advisory
committee is an important step toward achieving that goal."

The FDA assigned a Priority Review designation to the New Drug Application
(NDA) filed by Janssen in June seeking accelerated approval for bedaquiline.
Recommendations and findings from the advisory committee will be considered by
the FDA in its review of the NDA for bedaquiline, but the FDA is not bound to
follow them.

About the clinical development program
The regulatory submission is supported by 24-week data from the Phase 2
clinical development program.

Bedaquiline was evaluated in two Phase 2 studies in patients with MDR-TB.
TMC207-C208 was designed with two independent stages. Stage 1 was a
controlled, randomized, exploratory trial in which 47 patients were treated
for eight weeks with either bedaquiline or placebo in combination with a
standardized background regimen for MDR-TB. In Stage 2, a controlled and
randomized superiority trial, 160 patients were treated with either
bedaquiline (400 mg once daily for two weeks followed by 200 mg three times a
week for 22 weeks) or placebo in combination with a standardized background
regimen for MDR-TB. Background therapy was continued for an additional 12 to
18 months. The primary endpoint was time to culture conversion. 

A second single-arm, open-label, Phase 2 study, TMC207-C209, enrolled 233
patients from 11 countries to evaluate the efficacy, safety and tolerability
of bedaquiline in the treatment of MDR-TB. Bedaquiline was dosed 400 mg once
daily for two weeks followed by 200 mg three times weekly for 22 weeks in
combination with an individualized background regimen for MDR-TB, followed by
continued administration of the background regimen for 12 to18 months.

A confirmatory Phase 3 trial, TMC207-C210, is planned for 2013. It is designed
as a double-blind study comparing nine months of treatment with bedaquiline
versus placebo (both with a background regimen).

About Janssen Research & Development, LLC
Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has
affiliated facilities in Europe, the United States and Asia. Janssen Research
& Development is leveraging a combination of internal and external innovation
to discover and develop novel medicines and solutions in five distinct
therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and
Vaccines, and Cardiovascular and Metabolism. For more information about
Janssen Research & Development, LLC visit www.janssenrnd.com. Janssen Research
& Development is part of the Janssen Pharmaceutical Companies of Johnson &
Johnson. Driven by our commitment to patients, we work together to bring
innovative ideas, products, services and solutions to address serious unmet
medical needs around the world.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. 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 expectations and projections of Janssen Research &
Development, LLC and/or Johnson & Johnson. Risks and uncertainties include,
but are not limited to, general industry conditions and competition; economic
factors, such as interest rate and currency exchange rate fluctuations;
technological advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory
approvals; challenges to patents; changes in behavior and spending patterns or
financial distress of purchasers of healthcare products and services; changes
to governmental laws and regulations and domestic and foreign health care
reforms; trends toward health care cost containment; and increased scrutiny of
the healthcare industry by government agencies. 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
January 1, 2012. 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 Janssen Research & Development, LLC nor Johnson & Johnson
undertake to update any forward-looking statements as a result of new
information or future events or developments).

Media Contacts:
Pamela Van Houten
Phone: (908) 295-7367

Daniel De Schryver
Phone: +49 (173) 76 89 149

Investor contacts:
Stan Panasewicz
Phone: (732) 524-2524

Louise Mehrotra
Phone: (732) 524-6491

SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com
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