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INCIVO® (telaprevir) Receives European Commission Approval for Twice Daily Dosing for Treatment of Genotype-1 Chronic Hepatitis



  INCIVO® (telaprevir) Receives European Commission Approval for Twice Daily
      Dosing for Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV)

  PR Newswire

  BEERSE, Belgium, May 31, 2013

BEERSE, Belgium, May 31, 2013 /PRNewswire/ --

  - INCIVO®   triple therapy now offers a twice daily HCV treatment regimen
               which should improve patient adherence ^[1 ^] -

Janssen Infectious Diseases-Diagnostics BVBA (Janssen) announced today that
the European Commission (EC) has approved a new twice daily (BID) dosing of
INCIVO® (telaprevir), a direct acting antiviral (DAA) protease inhibitor, in
combination with pegylated-interferon and ribavirin (PR) for naive and
previous treatment experienced patients. The newly approved dosing regimen for
INCIVO® is now 1,125 mg twice daily in combination with PR, which aligns a
morning and evening dose to the already twice daily dosing schedule for
ribavirin versus 750 mg every 8 hours in combination with PR.

The EC approval is based on results from OPTIMIZE, a randomized, open-label,
multicenter Phase III study  in treatment naive patients with genotype-1
chronic HCV infection, which demonstrated that twice daily dosing of INCIVO®
1,125mg in combination with PR was non-inferior to the previously approved
dosing every 8 hours in the proportion of patients who achieved sustained
virologic response (74% versus 73%). ^[ ^2 ^] Twice daily dosing also showed
similar cure rates with twice daily or every 8 hours INCIVO dosing in patients
with cirrhosis. ^[ ^3 ^]

"The approval of INCIVO® twice daily is good news for patients with genotype-1
chronic HCV infection. Making treatments more simple and easier to manage,
without compromising efficacy,  will help to increase adherence and give
patients an even greater chance of achieving a cure," said Dr Maria Buti,
Hospital Valle Hebron and Ciberehd del Institut Carlos III, Barcelona, Spain.

The availability of new DAAs like telaprevir has transformed treatment options
for HCV. ^[ ^4 ^] Telaprevir has already played a significant role in
improving treatment outcomes with more than 80,000 patients treated with
telaprevir combination therapy worldwide since it was first approved in 2011.
^[ ^5 ^] It also offers the shortest total treatment duration of any available
HCV therapy, for a high proportion of treatment-naïve or relapse patients. ^[
^6 ^] ^, ^[ ^7 ^]

"Before the availability of direct acting antivirals like telaprevir, the best
clinicians could hope for was to cure only 40-50% of our genotype-1 HCV
patients. DAAs now offer us the chance to cure approaching 80% of these
patients, for many in a shorter amount of time. Successful treatment is
effectively a cure and causes a massive reduction in the complications of HCV,
such as liver cancer and cirrhosis. As with many diseases early therapy is
most effective and has the greatest impact on complications. The twice daily
dosing of telaprevir makes the treatment easier to administer and will make it
easier for patients to take advantage of the opportunity for a cure. We now
need to ensure that patients with HCV are identified and offered therapy,
before their disease progresses," said Graham Foster, Consultant Hepatologist,
Barts Health London.

"We are pleased by the European Commission approval of twice daily dosing for
telaprevir, which marks an improvement on an already important treatment
option for HCV. This medicine is the cornerstone of our efforts to improve the
lives of more people living with HCV and supporting healthcare professionals
around the world," said Gaston Picchio, Hepatitis Disease Area Leader at
Janssen.  

Telaprevir was first approved by the U.S. Food and Drug Administration (FDA)
in May 2011, marketed by Vertex Pharmaceuticals under the brand name INCIVEK
^[ ^TM ^] , and by the European Commission in September 2011, marketed by
Janssen Pharmaceutical Companies under the brand name INCIVO®.

About OPTIMIZE

740 naïve patients chronically infected with genotype-1 HCV were treated with
either a twice daily dosing of INCIVO 1,125 mg or dosing every 8 hours of
INCIVO 750 mg, each in combination with PR. At Week 12, telaprevir treatment
ended and patients continued on PR alone for an additional 12 or 36 weeks
depending on their viral response at Week 4. Patients were evaluated 12 weeks
after treatment ended (SVR12) to monitor sustained virological response (SVR)
rates. ^[ ^2 ^]

The SVR12 rate for the twice daily group was 74% (274/369) compared to 73%
(270/371) in the every 8 hour group with 95% confidence interval of the
difference: -4.9%, 12.0%. The lower limit of the 95% CI (-4.9%) was greater
than the pre-determined non-inferiority margin of -11% and therefore the
non-inferiority of twice daily group over every 8 hour group was demonstrated.
^[ ^7 ^]

About INCIVO® (telaprevir)

INCIVO® (telaprevir), in combination with peginterferon alfa and ribavirin
(PR), is indicated for the treatment of genotype-1 chronic HCV in adult
patients with compensated liver disease (including cirrhosis) who are
treatment naïve, and who have previously been treated with interferon alfa
(pegylated or non pegylated) alone or in combination with ribavirin, including
relapsers, partial responders and null responders. ^[ ^7 ^] INCIVO® is a small
molecule, selective inhibitor of the HCV serine protease, and a member of the
new class of medicine for the treatment of genotype-1 chronic HCV, direct
acting antivirals (DAAs). Unlike previous treatments, DAAs act directly on
viral enzymes and prevent the virus from replicating.  INCIVO® was approved by
the European Commission on the 19 ^th September 2011.  

INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally
twice daily (BID) with food. Alternatively, 750 mg (two 375 mg tablets) can be
taken orally every 8 hours (q8h) with food. The total daily dose is 6 tablets
(2,250 mg). ^[ ^7 ^]

Telaprevir was developed by Janssen Infectious Diseases-Diagnostics BVBA, one
of the Janssen Pharmaceutical Companies, in collaboration with Vertex
Pharmaceuticals Incorporated (Vertex) and Mitsubishi Tanabe Pharma Corporation
(Mitsubishi Tanabe Pharma). Janssen has rights to commercialize telaprevir in
Europe, South America, Australia, the Middle East and certain other countries.
Vertex has rights to commercialize telaprevir in North America where it is
being marketed under the brand name INCIVEK ^[ ^TM ^] . Mitsubishi Tanabe
Pharma has rights to commercialize telaprevir in Japan and certain Far East
countries where it is being marketed as TELAVIC®.

Important Safety Information

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

The overall safety profile of telaprevir is based on the Phase II/III clinical
development programme containing 3,441 patients who received a telaprevir
based regimen. 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 adverse reactions (incidence ≥ 5.0%) of at least grade 2
in severity were anemia, rash, pruritus, nausea, and diarrhoea during the
telaprevir treatment phase, and the most frequently reported adverse reactions
(incidence ≥ 1.0%) of at least Grade 3 were anemia, rash, thrombocytopenia,
lymphopenia, pruritus, and nausea. ^[ ^7 ^] INCIVO® prescribing information
includes special warnings and pre-cautions for use with regards to rash
including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and
Stevens - Johnson syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), where
INCIVO, peginterferon alfa and ribavirin should be immediately and permanently
 discontinued and a specialist in dermatology consulted. ^[ ^7 ^] In cases of
mild and moderate rash discontinuation of INCIVO® is not always required and
patients are advised to consult with a healthcare professional. In cases of
severe rash immediate discontinuation of INCIVO® is required and consultation
with a specialist in dermatology is recommended. ^[ ^7 ^]

Rash events were reported in 55% of patients with a telaprevir based regimen
compared to 33% of patients treated with peginterferon alfa and ribavirin only
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 of telaprevir alone in 5.8% of patientsand 2.6% of
patients discontinued telaprevir combination treatment for rash events
compared to none of those receiving peginterferon alfa and ribavirin. ^[ ^7 ^]

Hemoglobin values of < 10 g/dl were observed in 34% of patients who received
telaprevir combination treatment and in 14% of patients who received
peginterferon alfa and ribavirin. In placebo-controlled Phase 2 and 3 trials,
1.9% of patients discontinued telaprevir alone due to anemia, and 0.9% of
patients discontinued INCIVO combination treatment due to anemia compared to
0.5% receiving peginterferon alfa and ribavirin. ^[ ^7 ^]

About HCV

Hepatitis C (HCV) is a contagious liver disease which is spread through
blood-to-blood contact and is usually symptomless at the outset. ^[ ^8 ^] With
an estimated 150 million people infected worldwide, ^[ ^9 ^] and three to four
million people newly infected each year, HCV puts a significant burden on
patients and society. ^[ ^10 ^] Estimations indicate that HCV kills more than
350,000 people worldwide per year, accounting for approximately 1% of deaths
worldwide. ^[ ^9 ^] It is the world's primary cause of cirrhosis and liver
cancer ^[ ^11 ^] with an estimated 20-30% of patients developing liver
cirrhosis ^[ ^12 ^] and a further 7% developing liver cancer. ^[ ^13 ^] The
estimated annual cost of HCV (medical and work loss) is more than $1 billion
in the U.S. alone. ^[ ^14 ^]

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.  Please visit
http://www.janssenrnd.com for more information.

                                     ###

References:

 1. Sievert W et al . Adherence with Telaprevir BID vs. Q8h Dosing in
    Treatment Naive HCV-infected Patients: Results from the Phase III OPTIMIZE
    Study. J Hepatol 2013; 58(Suppl 1): S373.
 2. Buti M, Agarwal K, Horsmans Y, et al . OPTIMIZE Trial: Non-inferiority of
    twice-daily telaprevir versus administration of every 8 hours in
    treatment-naïve, genotype 1 HCV infected patients. 2012. American
    Association for the Study of Liver Diseases (AASLD) Abstract. (Final ID:
    LB-8).
 3. Horsmans Y, Brown Jr. RS, Buti M, et al . Safety and efficacy of twice
    daily versus every 8 hour telaprevir with peginterferon/ribavirin (PR) in
    patients with cirrhosis. 2013. European Association for the Study of the
    Liver (EASL) Abstract 862.
 4. Casey L C, Lee W M. Hepatitis C Virus Therapy Update 2013. Curr Opin
    Gastroenterol . 2013;29(3):243-249.
 5. Janssen data on file.
 6. Sherman K, et al. Duration of Initial Telaprevir Treatment for HCV
    Infection: A phase 3 study of treatment duration. N Engl J Med .
    2011;365:1014-24.
 7. INCIVO® Summary of Product Characteristics updated 2013.
 8. Centers for Disease Control and Prevention. Hepatitis C FAQs. Available
    at: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission (last accessed
    May 2013).
 9. World Health Organization. Hepatitis C Fact Sheet. Available at:
    http://www.who.int/mediacentre/factsheets/fs164/en/index.html (last
    accessed May 2013).
10. WHO. State of the art of vaccine research and development. Viral Cancers.
    Available at:
    http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf (last
    accessed May 2013).
11. Rosen HR. Clinical practice. Chronic hepatitis C infection. N Engl J Med .
    2011 Jun 23;364(25):2429-38.
12. Hep C Trust: Overview of Stages. Available at:
    http://www.hepctrust.org.uk/Hepatitis_C_Info/Stages+of+Hepatitis+C/Overview+of+the+stages
    (last accessed May 2013).
13. Blachier M, Leleu H, Peck-Radosavljevic M, et al. The Burden of liver
    disease in Europe: A review of available epidemiological data. European
    Association for the Study of the Liver 2013 .
14. El Khoury A, Klimack W, Wallace C, et al . Economic burden of hepatitis
    C-associated diseases in the United States. J Viral Hep .  2012
    March;19:153-160

Contact: MEDIA CONTACT: Ronan Collins, +44(0)7876-257-746, Ines Hammer,
+33(6)8809-33-35
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