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
TITUSVILLE, N.J., Nov. 1, 2012
TITUSVILLE, N.J., 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
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."
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:
oJanssen's TMC647055 and ritonavir in treatment-naive, relapser or
null-responder HCV genotype 1 patients;
oGilead Sciences, Inc.'s sofosbuvir (GS-7977) in null-responder HCV
genotype 1 patients; and
oBristol-Myers Squibb's daclatasvir (BMS-790052) in treatment-naive or
previous null-responder HCV genotype 1 patients.
For additional information about simeprevir, please visit
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.
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.comor 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.)
SOURCE Janssen Pharmaceuticals, Inc.
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:
Press spacebar to pause and continue. Press esc to stop.