INCIVO® (Telaprevir) Approved in Europe Offering Higher Cure Rates for Genotype-1 Chronic Hepatitis C Compared to Standard Treatment

Beerse, Belgium (ots/PRNewswire) -

New Treatment Options Increase Chance of a Cure

Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical
Companies, announced today that the European Commission has approved
INCIVO(R) (telaprevir), a direct acting antiviral (DAA) protease
inhibitor, for the treatment of genotype-1 chronic hepatitis C virus
(HCV), in combination with peginterferon alfa and ribavirin, in
adults. With this new class of medicines, of which telaprevir is the
latest addition, more genotype-1 chronic HCV patients than ever
before will have the chance of a cure.

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In clinical studies, telaprevir in combination with peginterferon
alfa and ribavirin demonstrated significant improvements in cure
rates, also known as sustained virologic response (SVR), for both
previously untreated genotype-1 chronic HCV patients and those who
have failed previous treatment compared to the standard treatment
with peginterferon alfa and ribavirin alone.[1,2] The approval of
telaprevir offers an improved and efficacious treatment regimen
compared to the standard treatment for genotype-1 chronic HCV with
the shortest course of treatment of any available treatment.[3,4]
Telaprevir reduces the current total treatment duration by half in
the majority of previously untreated patients and those who have
relapsed.

"Today is an exciting day for adults with genotype-1 chronic HCV
infection. Before the introduction of protease inhibitors, treatment
for HCV required a long duration and cured less than half of
genotype-1 chronic HCV patients," said Professor Graham Foster, Queen
Mary's University Hospital of London. "For many adults with
genotype-1 chronic HCV, treatment with a telaprevir based regimen
could provide a shorter treatment duration with improved cure rates
compared to standard treatments. Shortening treatment regimens,
without compromising efficacy, is a valuable step to help patients
adhere to their treatment."

The approval is based on the results of three Phase 3 studies in
2290 patients: ADVANCE, REALIZE and ILLUMINATE.[1,2,3] ADVANCE and
REALIZE were randomized, double-blind, placebo-controlled studies
that evaluated the efficacy and safety of telaprevir in combination
with peginterferon alfa and ribavirin compared with the previous
standard treatment (peginterferon alfa and ribavirin alone).[1,2] The
data showed that treatment with a telaprevir based regimen
significantly increased cure rates for genotype-1 chronic HCV
compared to the previous standard treatment in previously untreated
patients (79% vs. 46%, p<0.0001) and patients who relapsed during
previous treatment (84% vs. 22%, p<0.0001).[1,2] The data also showed
a significant increase in cure rates for patients who either
partially responded or did not respond to previous treatment, groups
typically among the hardest to cure, compared to peginterferon alfa
and ribavirin alone (61% vs. 15% and 31% vs. 5%, p<0.0001
respectively).[2]

Data from ILLUMINATE showed 24 weeks of treatment with a
telaprevir based regimen was non-inferior to 48 weeks of a telaprevir
based regimen for previously untreated genotype-1 chronic HCV
patients who achieved and maintained an undetectable viral load early
in their treatment at weeks 4 and 12 (also known as extended rapid
viral response or eRVR).[3]

Chronic HCV is considered a 'viral timebomb' by the World Health
Organization and can have severe consequences for both patients and
public health systems.[5] More than 170 million people worldwide are
infected with chronic HCV and many are unaware of their infection.[6]

"Hepatitis C can be a devastating disease; however, if treated
successfully, patients can avoid life-threatening liver problems such
as further liver damage, cirrhosis, liver failure and liver cancer.
The arrival of Direct Acting Antivirals is the first treatment
breakthrough in more than 10 years and a significant step forward for
the hepatitis C community. It will offer more patients hope for a
cure," said Charles Gore, World Hepatitis Alliance.

The overall safety profile of telaprevir is based on the Phase
2/3 clinical development programme. In clinical trials, the incidence
of adverse events of at least moderate intensity was higher in the
telaprevir group than in the placebo group (both groups receiving
peginterferon alfa and ribavirin). The most frequently reported
moderate adverse reactions( incidence greater than or equal to 5.0%)
were anaemia, rash, pruritus, nausea, and diarrhoea, and the most
frequently reported severe adverse reactions (incidence greater than
or equal to 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia,
pruritus, and nausea.[4]

Rash events were reported in 55% of patients with a telaprevir
based regimen and more than 90% of rashes were of mild or moderate
severity. Severe rashes were reported with telaprevir combination
treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of
patients. Anaemia was reported in 32.1% of patients and led to
discontinuation in approximately 3%.[4]

"We are delighted by the European Commission approval of
telaprevir and that we can now offer patients a significantly
improved treatment option for HCV compared to the previous standard
treatment," said Ramon Polo, Telaprevir Compound Development Team
Leader. "Telaprevir is a cornerstone of the Janssen Companies'
expanding infectious disease portfolio, which includes therapies in
HIV/AIDS, tuberculosis, serious infections and now HCV that are
helping to redefine and improve treatment outcomes. The Janssen
Companies remain dedicated to improving the lives of patients and
supporting healthcare professionals around the world."

About INCIVO(R)

INCIVO(R) will be made available by the Janssen Companies in
countries throughout the European Union. Telaprevir was developed by
Tibotec, one of the Janssen Pharmaceutical Companies, in
collaboration with Vertex 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(R); Vertex has the right to
commercialize telaprevir in North America under the name INCIVEK(TM)
(approved by US FDA in May 2011 and by Health Canada in August 2011
for genotype-1 chronic hepatitis C with compensated liver disease);
Mitsubishi Tanabe Pharma has the right to commercialize telaprevir in
Japan and certain Far Eastern countries.

Important Safety Information

Please see full Summary of Product Characteristics or visit
http://www.emea.europa.eu for more details.

About HCV

HCV is a blood-borne infectious disease that affects the
liver.[7,8] With an estimated 170 million people infected
worldwide,[6,8] 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. About one-quarter of the liver transplants
performed in 25 European countries in 2004 were attributable to
HCV.[9] The previously accepted standard treatment for HCV is
peginterferon alfa combined with ribavirin,[8] however this only
cures 40-50 percent of chronic genotype-1 HCV patients.[10]

HCV puts a significant burden on patients and society.
Estimations indicate that HCV caused more than 86,000 deaths and 1.2
million disability-adjusted life-years (DALYs) in the WHO European
region in 2002.[9] Most of the DALYs (95%) were accumulated by
patients in preventable disease stages.[9]

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 http://www.janssen-emea.com

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 http://www.sec.gov, http://www.jnj.com or on
request from Johnson & Johnson.

The Janssen 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:

1) John McHutchinson 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.
2) 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.
3) Sherman, K et al. Telaprevir incombination with pegiterferon
alfa2a and ribavirin for 24 or 48 weeks in treatment-naïve 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.
4) INCIVO(R) Summary of Product Characteristics 2011.
5) WHO. State of the art of vaccine research and development.
Viral Cancers. Available from
http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).
6) World Health Organization. Hepatitis C. Weekly Epidemiological
Record. 1997;72:65-69.
7) Centres for Disease Control and Prevention. Hepatitis C FAQs.
[cited 2009 Dec 17] Available from:
http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission.
8) Simin M et al. Cochrane systematic review: peginterferon
alfaplus ribavirin vs. interferon plus ribavirin for chronic hepatitis
C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.
9) Nikolai Mühlberger et al. HCV-related burden of disease in
Europe: a systematic assessment of incidence, prevalence, morbidity, and
mortality. BMC Public Health. 2009; 9(34):1-14.
10) The Hepatitis C Trust. Treatments: Potential New Drugs. [cited
2010 Feb 20] Available from:
http://www.hepctrust.org.uk/treatment/potential-new-drugs/Drugs+that+target+the+virus
.

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