INCIVO(R) Receives Positive Opinion From the Committee for Medicinal Products for Human use (CHMP) for the Treatment of Genotype-1 Hepatitis C Virus (HCV)
By Tibotec Virco-virology Bvba, PRNEThursday, July 21, 2011
BEERSE, Belgium, July 22, 2011 -
- Expanding New Treatment Class for Patients With HCV
-
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical
Companies, announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) adopted a positive opinion recommending the approval of
INCIVO (telaprevir), a direct acting antiviral (DAA) for the
treatment of chronic genotype-1 hepatitis C virus (HCV), in
combination with pegylated-interferon and ribavirin, the previously
accepted standard of care.
The CHMP positive opinion is based on results from three phase
III clinical trials, ADVANCE[1], REALIZE[2]
and ILLUMINATE[3] which evaluated the efficacy and
safety of telaprevir in combination with pegylated-interferon and
ribavirin in more than 2,290 treatment-naïve and previously-treated
genotype 1 HCV patients.[1,2,3] Data from ADVANCE and
REALIZE were published in the 23rd June edition of the
New England Journal of Medicine. Data from the ILLUMINATE
study were presented at the 61st annual meeting of the American
Association for the Study of Liver Diseases in 2010.
The CHMP positive opinion is a critical step in the approval
process and will be considered by the European Commission, which
has authority to approve medicines for use throughout the European
Union. Telaprevir was approved by the U.S. Food and Drug
Administration (FDA) in May 2011 and is marketed by Vertex
Pharmaceuticals under the brand name INCIVEK[TM].
Following marketing authorization approvals, telaprevir will be
marketed in the EU and certain other global territories under the
brand name INCIVO by the Janssen Companies.
“We are encouraged by this positive decision from the CHMP and
will continue to work closely with other regulatory authorities to
make telaprevir available for people with HCV. If approved by
the European Commission, the addition of telaprevir will offer
patients an improved treatment option compared to the previously
accepted standard of care, which only cures 40-50 percent of
genotype 1 patients,” said Ramon Polo, INCIVO Compound Development
Team Leader. “Telaprevir is part of Janssen’s expanding infectious
disease portfolio, which is comprised of innovative therapies in
HIV/AIDS, tuberculosis and now HCV that are helping to redefine and
improve treatment outcomes. Janssen remains dedicated to improving
the lives of patients and supporting healthcare professionals
around the world.”
About INCIVO
INCIVO is being developed by Tibotec, one of the Janssen
Pharmaceutical Companies, in collaboration with Vertex
Pharmaceuticals and Mitsubishi Tanabe Pharma. The Janssen Companies
have the right to commercialize telaprevir in Europe, Latin
America, the Middle East, Africa, India, Australia and New Zealand
under the commercial name INCIVO®; Vertex has the right
to commercialize telaprevir in North America under the name
INCIVEK™; Mitsubishi Tanabe Pharma has the right to commercialize
telaprevir in Japan and certain Far Eastern countries.
On May 23rd 2011, US FDA approved telaprevir for the
treatment of people with chronic genotype 1 hepatitis C with
compensated liver disease.
About HCV
HCV is a blood-borne infectious disease that affects the
liver.[4] With an estimated 170 million people infected
worldwide, and three to four million people newly infected each
year,[5] HCV puts a significant burden on patients and
society. Chronic infection with HCV can lead to liver cancer and
other serious and fatal liver diseases, and is the most common
cause of liver transplant in Europe.[6] The previously
accepted standard of treatment for HCV is pegylated-interferon
combined with ribavirin,[7] however this only cures
40-50 percent of genotype 1 patients.[8]
About Tibotec
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, is a global pharmaceutical and
research development company. The Company’s main research and
development facilities are in Beerse, Belgium with offices in
Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the
discovery and development of innovative HIV/AIDS and hepatitis C
drugs, and anti-infectives for diseases of high unmet medical
need.
About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson
are dedicated to addressing and solving the most important unmet
medical needs of our time, including oncology , immunology,
neuroscience, infectious disease, 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.
More information can be found at
This press release contains “forward-looking statements” as
defined in the Private Securities Litigation Reform Act of
1995. 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 Tibotec Virco-Virology BVBA, any of the other Janssen
Pharmaceutical Companies 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 and patents attained by competitors;
challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care
reforms and governmental laws and regulations; 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 2, 2011. Copies
of this Form 10-K, as well as subsequent filings, are
available online at
www.jnj.com
or on request from Johnson & Johnson. TheJanssen
Pharmaceutical Companies and Johnson & Johnson do not
undertake to update any forward-looking statements as a result of
new information or future events or developments.
References:
- John G et al. Telaprevir in Combination with Peginterferon and
Ribavirin in Genotype 1 HCV Treatment-Naïve Patients: Final Results
of Phase 3 ADVANCE study. Paper presented at: The Liver Meeting of
the American Association for the Study of Liver Diseases (AASLD);
2010. - Zeuzem S, Andreone P, Pol S et al. REALIZE trial final
results: telaprevir-based regimen for genotype 1 hepatitis C virus
infection in patients with prior null response, partial response or
relapse to peginterferon/ribavirin. Paper presented at: 46th annual
meeting of the European Association for the Study of the Liver
(EASL); 2011. - Sherman KE et al. Telaprevir in Combination with Peginterferon
Alfa2a and Ribavirin for 24 or 48 weeks in Treatment-Naive Genotype
1 HCV Patients who Achieved an Extended Rapid Viral Response: Final
Results of Phase 3 ILLUMINATE Study. Paper presented at: The Liver
Meeting of the American Association for the Study of Liver Diseases
(AASLD); 2010. - Centres for Disease Control and Prevention. Hepatitis C FAQs.
[cited 2009 Dec 17] Available from:
www.cdc.gov/hepatitis/C/cFAQ.htm#transmission. - World Health Organization. Hepatitis C. Weekly Epidemiological
Record. 1997;72:65-69. - The Hepatitis C Trust. Treatments: Potential New Drugs. [cited
2010 Feb 20] Available from:
www.hepctrust.org.uk/Treatment/Potential+New+Drugs/Drugs+that+target+the+virus.htm. - McHutchison J. et al. Peginterferon Alfa-2b or Alfa-2a with
Ribavirin for Treatment of Hepatitis C Infection. N Engl J Med.
2009; 361: 580-93. - Simin M et al. Cochrane systematic review: pegylated interferon
plus ribavirin vs. interferon plus ribavirin for chronic hepatitis
C. Alimentary Pharmacology & Therapeutics. 2007;
25(10):1153-62.
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INVESTOR RELATIONS: Stan Panasewicz, +1-732-524-2524, Louise
Mehrotra, +1-732-524-6491
.
Tags: Beerse, belgium, July 22, Tibotec Virco-virology Bvba
