Janssen Announces Collaboration With Vertex On Phase 2 Study To Investigate An All-Oral Regimen Of Simeprevir (TMC435) And VX

Janssen Announces Collaboration With Vertex On Phase 2 Study To Investigate An
All-Oral Regimen Of Simeprevir (TMC435) And VX-135 For Treatment Of Hepatitis

  PR Newswire

  TITUSVILLE, New Jersey, Nov. 1, 2012

TITUSVILLE, New Jersey, Nov. 1, 2012 /PRNewswire/ -- Janssen Pharmaceuticals,
Inc. today announced that it has entered into a non-exclusive collaboration
with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 study the
safety and efficacy of an all-oral regimen for the treatment of hepatitis C
(HCV). The regimen will include Janssen's investigational protease inhibitor
simeprevir (TMC435) and Vertex's investigational nucleotide analogue HCV
polymerase inhibitor VX-135. As a first step, Janssen will conduct a drug-drug
interaction (DDI) study with simeprevir and VX-135. The DDI study will support
the initiation of the Phase 2 study in early 2013 pending discussions with
regulatory authorities.

The goal of the Phase 2 study will be to evaluate the safety, tolerability and
viral cure rates of a 12-week regimen of simeprevir and VX-135, administered
with and without ribavirin, in treatment-naive patients who have chronic
non-cirrhotic genotype 1 HCV. The companies will jointly fund development
costs associated with the collaboration. There are no up-front or milestone
payments associated with the agreement.

Simeprevir is an investigational NS3/4A protease inhibitor currently in Phase
3 trials, developed in collaboration with and licensed from Medivir AB. VX-135
is an investigational uridine nucleotide analogue pro-drug designed to inhibit
the replication of HCV by acting on the NS5B polymerase.

"There is a significant unmet need for all-oral treatment regimens for people
living with hepatitis C," said Wim Parys, Global Head of Infectious Diseases
at Janssen. "Janssen's collaboration with Vertex underscores our commitment to
better understand the potential utility of simeprevir in a number of different
interferon-free treatment combinations and HCV patient populations."

About Simeprevir Simeprevir (TMC435) is an NS3/4A protease inhibitor jointly
developed by Janssen and Medivir AB to treat chronic HCV infection. Simeprevir
is being studied in combination with pegylated interferon and ribavirin, and
in combination with direct-acting antiviral (DAA) agents in all-oral
interferon-free regimens, with and without ribavirin.

Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in
treatment-naive patients, PROMISE in patients who have relapsed after prior
interferon-based treatment and ATTAIN in treatment-experienced patients. In
parallel to these trials, Phase 3 studies for simeprevir are ongoing in both
treatment-naive and treatment-experienced HIV-HCV co-infected patients, HCV
genotype 4 patients and in Japanese HCV genotype 1 patients.

Simeprevir is also being studied in other Phase 2 interferon-free trials, with
and without ribavirin, in combination with:

  *Janssen's TMC647055 and ritonavir in treatment-naive, relapser or
    null-responder HCV genotype 1 patients;
  *Gilead Sciences, Inc.'s sofosbuvir (GS-7977) in null-responder HCV
    genotype 1 patients; and
  *Bristol-Myers Squibb's daclatasvir (BMS-790052) in treatment-naive or
    previous null-responder HCV genotype 1 patients.

For additional information about simeprevir, please visit
www.clinicaltrials.gov .

About Hepatitis C Hepatitis C, a blood-borne infectious disease of the liver
and a leading cause of chronic liver disease and liver transplants, is a
rapidly evolving treatment area with a clear need for innovative treatments.
Approximately 170 to 210 million people are infected with hepatitis C
worldwide, with three to four million people newly infected each year.

About Janssen At Janssen, we are dedicated to addressing and solving some of
the most important unmet medical needs of our time in infectious diseases and
vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic
diseases. Driven by our commitment to patients, we develop innovative
products, services and healthcare solutions to help people throughout the
world. Janssen Pharmaceuticals, Inc. and Janssen Research & Development are
part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please
visit http://www.janssenrnd.com for more information.

About Vertex and VX-135 To find out more about Vertex and VX-135 please visit
www.vrtx.com .

(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
Pharmaceuticals, Inc. 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 or other intellectual
property rights; changes in behavior and spending patterns or financial
distress of purchasers of health care 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 health care 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 Pharmaceuticals, Inc. nor Johnson & Johnson
undertake to update any forward-looking statements as a result of new
information or future events or developments.)

Website: http://www.janssenrnd.com
Contact: Media, Daniel De Schryver, Mobile: +49-173-76-89-149, or Pamela Van
Houten, Mobile: +1-908-295-7367; or Investors, Stan Panasewicz, Office:
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