--OSIRIS study results presented at the Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD) in San
Francisco--
BEERSE, Belgium--(BUSINESS WIRE)--
Janssen-Cilag International NV (Janssen) today announced the preliminary
results from the Phase IIa OSIRIS trial, at the Liver Meeting®,
the Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) in San Francisco. The OSIRIS trial, investigating once
daily OLYSIO® (simeprevir) in combination with
sofosbuvir in hepatitis C virus (HCV) genotype 4 infected patients, with
and without liver cirrhosis, demonstrated treatment to be safe and
generally well tolerated, with Sustained Virological Response (SVR12)
rates of up to 100% in patients treated for 12 weeks regardless of
fibrosis stage and treatment history.1
"Genotype 4 is the most common HCV genotype within the Middle Eastern
region and is especially prevalent in Egypt where 8%-10% of the
population are infected with HCV, and almost all infections are due to
genotype 4," said Professor Waked, Professor of Medicine,
National Liver Institute, Egypt and lead OSIRIS study investigator.
"With the majority of published research being focused on genotype 1
HCV, it's important to conduct studies such as the OSIRIS trial to aid
our understanding of how best to treat genotype 4 infected patients."
The OSIRIS trial assessed genotype 4 infected patients (n=63) both
treatment naïve and treatment experienced, with and without liver
cirrhosis, who were treated with 150mg of simeprevir in combination with
400mg sofosbuvir once daily. Patients without liver cirrhosis were
randomized to receive either 8 or 12 weeks of treatment while patients
with cirrhosis were assigned to receive 12 weeks of treatment.1
Results demonstrated 100% SVR12 rates in patients (n=43) treated for 12
weeks, and 75% in patients (n=20) treated for 8 weeks. Out of the five
patients who relapsed in the 8 week arm, all were non-responder to other
therapies with IL28B non-CC genotype. The most common adverse events
(≥10%) were increased lipase, pruritus, and headache. One patient
reported treatment-emergent serious adverse events (pleural effusion and
pulmonary hypertension;) neither considered to be related to simeprevir.
There were no discontinuations due to adverse events.1
"The results of the OSIRIS trial presented at the Liver Meeting® show
simeprevir in combination with sofosbuvir to be an effective interferon
free treatment option for patients infected with genotype 4 HCV," said
Isabelle Lonjon-Domanec, European Therapeutic Area Leader Infectious
Diseases, Janssen Pharmaceuticals. "The Middle East and North Africa
have some of the highest prevalence of HCV in the world and it's
important to find treatment options that are effective in the fight
against HCV in these countries."
HCV continues to be a major public health burden in Egypt, where an
estimated 7.5 million people are living with the disease.2,3 Treatment
of HCV is complex because of the unpredictable course of the infection
and the heterogeneous population of patients it affects. Treatment
efficacy is also highly dependent on the genotype of the virus.
Janssen remains committed to investigating and providing effective
treatment solutions for patients, particularly in the geographies where
high unmet needs continue to demand attention.
For further information on simeprevir's indication in Europe, please
view the European and UK summary of product characteristics: http://www.medicines.org.uk/emc/medicine/28888
-ENDS-
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading
cause of chronic liver disease, is a major global public health concern.
Approximately 170 million people are infected with hepatitis C worldwide4
and 350,000 people per year die from the disease globally5.
When left untreated, hepatitis C can cause significant damage to the
liver, including cirrhosis. Additionally, hepatitis C may increase the
risk of developing complications from cirrhosis, which may include liver
failure.4
About Janssen's HCV Clinical Development Program
The goal of the Janssen HCV clinical development program is to provide
physicians with multiple treatment options in order to offer patients
the best possible chance at successful therapy. Ongoing studies focus on
the investigation of simeprevir in a number of different treatment
combinations and HCV patient populations, including those who are
difficult to cure.
Following the acquisition of Alios BioPharma by Johnson & Johnson
in November 2014 the Janssen HCV pipeline also includes AL-335, a
uridine based nucleotide analog in Phase 1 development, and AL-516, a
guanosine-based nucleotide analog NS5B polymerase inhibitor in
pre-clinical development.
In May 2015, Janssen Pharmaceuticals Inc. entered into an exclusive
worldwide license and collaboration arrangement with Achillion
Pharmaceuticals, Inc. to develop and commercialize one or more of
Achillion's lead HCV assets which include ACH-3102, ACH-3422 and
sovaprevir. A key objective of the collaboration will be to combine
assets from the respective portfolios to develop a short-duration,
highly effective, pan-genotypic, oral regimen for the treatment of HCV.
About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor which has been developed by
Janssen Sciences Ireland UC in collaboration with Medivir AB.
In November 2013, simeprevir was initially approved by the U.S. Food and
Drug Administration, and in May 2014, it was granted marketing
authorisation by the European Commission. Subsequent marketing
authorisations have followed in several other countries around the
world. Indications vary by market.
Janssen is responsible for the global clinical development of simeprevir
and has exclusive, worldwide marketing rights, except in the Nordic
countries. Medivir AB retains marketing rights for simeprevir in these
countries under the marketing authorisation held by Janssen-Cilag
International NV.
About Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, 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-Cilag International NV is part of the
Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssen.com
for more information.
# # #
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995 regarding product
development. 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 known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Janssen R&D Ireland and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in new product development, including the
uncertainty of clinical success and of obtaining regulatory approvals;
competition, including technological advances, new products and patents
attained by competitors; challenges to patents; changes to applicable
laws and regulations, including global health care reforms; and trends
toward health care cost containment. A further list and description of
these risks, uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December
28, 2014, including in Exhibit 99 thereto, and the company's subsequent
filings with the Securities and Exchange Commission. Copies of these
filings are available online at www.sec.gov,
www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
(PHGB/HEP/1115/0006)
References
1 OSIRIS poster, presented at the Liver Meeting®,
the Annual Meeting of the American Association for the Study of Liver
Diseases, 2015.
2 UNFPA. Egypt - Because Everyone Counts. Available at: http://egypt.unfpa.org/english/Staticpage/54790f72-6e8b-4f77-99e2-4c5b78c20d5c/indicators.aspxAccessed
October 2015
3Centres for Disease Control and Prevention. Progress Toward
Prevention and Control of Hepatitis C Virus Infection — Egypt,
2001-2012. Accessed October 2015
4World Health Organisation, Hepatitis C. Available at: http://www.who.int/csr/disease/hepatitis/Hepc.pdf
Last accessed October 2015.
5World Health Organisation. Hepatitis C. Fact sheet N. 164.
Available at: http://www.who.int/mediacentre/factsheets/fs164/en/.
Last accessed October 2015.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151116005619/en/
Janssen
Media Contact:
Hans Vanavermaete
Mobile:
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or
Investor Contact:
Lesley Fishman
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Louise Mehrotra
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6491
Source: Janssen
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