Janssen Pharmaceutica

Twice-daily INCIVO® (Telaprevir), in Combination With Peginterferon Alfa and Ribavirin, is Effective in Treating People Living With Genotype-1 Chronic Hepatitis C Virus

Beerse, Belgium (ots/PRNewswire) - NOT INTENDED FOR US JOURNALISTS

- OPTIMIZE study results to be presented in late-breaking poster presentation at the American Association for the Study of Liver Diseases (AASLD) 2012 show

non-inferior sustained virological response (SVR12) rates in previously untreated genotype-1 patients receiving an INCIVO(R) (telaprevir) based regimen twice-daily versus

every eight hours -

Janssen Research & Development Infectious Diseases - Diagnostics BVBA (Janssen) will present results from the OPTIMIZE Phase 3 trial for INCIVO(R) (telaprevir), during a late-breaking poster presentation at the 63rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston (http://www.aasld.org/lm2012). The study, which was completed in September, investigates the efficacy and safety of the twice-daily dosing (BID) of telaprevir versus dosing every eight hours (q8h) in people chronically infected with genotype-1 hepatitis C virus (HCV) who had not been previously treated.[1]

"This is the first Phase 3 study to evaluate twice daily dosing of the new class of protease inhibitors for the treatment of hepatitis C, so this will be significant news for patients and clinicians," said Maria Buti, Lead Study Investigator and Professor of Medicine at Hospital General Universitari VAll d'Hebron, Barcelona. "Telaprevir has already halved the treatment duration for the majority of people with hepatitis C whilst significantly improving cure rates, compared to previous standard of care, peginterferon alfa and ribavirin (PR). These data offers hope for yet further improvements to treatment regimens, with no compromise on cure rates."

The results demonstrated that BID dosing of telaprevir 1,125mg in combination with peginterferon alfa and ribavirin (PR), achieved similar cure rates, also known as sustained virological response (SVR12) to q8h dosing of telaprevir 750mg (74.3% versus 72.8%), thereby meeting its primary objective of non-inferiority versus q8h dosing.[1] The safety and tolerability of telaprevir was comparable across dosing arms and consistent with previous studies. The most common adverse events experienced were fatigue, pruritus, anemia, nausea and rash.[1]

OPTIMIZE was a randomized, open-label, multicenter Phase 3 study in patients with genotype-1 chronic HCV infection who had not been previously treated. During the study, 744 patients were randomized to either BID dosing of telaprevir 1,125mg or q8h dosing of telaprevir 750mg (current INCIVO(R) label), in combination with PR. At 12 weeks, telaprevir treatment ended and patients continued on PR alone for up to week 24 or week 48 depending on their viral response at week 4. Patients were followed up for a further 12 weeks to monitor cure rates (SVR12).[1]

Additional telaprevir data to be presented at AASLD will include:

- Efficacy and safety of telaprevir in patients co-infected with HCV and HIV[2]

- Interim analysis results from the telaprevir Global Early Access Programme highlighting the efficacy and safety of treatment amongst genotype-1 HCV patients with severe fibrosis or compensated cirrhosis[3]

- Factors predictive of anemia development in treatment-experienced patients receiving telaprevir plus PR in the REALIZE trial[4]

- Rate of disappearance of telaprevir resistant variants using clonal and population sequence data from Phase 3 studies[5]

- Evaluation of liver and plasma HCV RNA kinetics and telaprevir levels in genotype-1 HCV patients treated with telaprevir (TVR) using serial fine needle aspirates (FNA)[6]

- Deep sequencing of the HCV NS3/4A region confirms low prevalence of telaprevir-resistant variants both at baseline and end of study[7]

About INCIVO(R)

INCIVO(R) (telaprevir), in combination with peginterferon alfa and ribavirin, 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.[8] 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 19 September 2011.

Telaprevir was developed by Janssen Research & Development 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(R).

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 2/3 clinical development programme containing 2,641 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 greater than or equal to 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 greater than or equal to 1.0%)of at least Grade 3 were anemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.[8]

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.[8]

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.[8]

About HCV

HCV is a blood-borne infectious disease that affects the liver.[9],[10] With an estimated 130-210 million people infected worldwide,[11]and three to four million people newly infected each year, HCV puts a significant burden on patients and society.[12] 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 (latest available data).[13] Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases.[14] About one-quarter of the liver transplants performed in 25 European countries in 2004 were attributable to HCV (latest available data).[13] The previously accepted standard treatment for HCV was peginterferon alfa combined with ribavirin,[14] however this only cleared the virus for 40-50 percent of genotype-1 chronic HCV patients.[15],[16]

About Janssen

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 Research & Development Infectious Diseases - Diagnostics BVBA is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

1. 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.

2. Sulkowski MS, Sherman KE, Soriano V , et al. Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final Study Results. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

3. Colombo M et al. Treatment of Hepatitis C Genotype 1 Patients with Severe Fibrosis or Compensated Cirrhosis: The International Telaprevir Early Access Program. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

4. Zeuzem S, DeMasi R, Baldini A, et al. Factors predictive of anemia development in treatment-experienced patients receiving telaprevir (T;TVR) plus peginterferon/ribavirin (PR) in the REALIZE trial. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

5. Sullivan J, De Meyer S, Haseltine E, et al. Rate of disappearance of telaprevir resistant variants using clonal and population sequence data from Phase 3 studies. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

6. Talal A, Dimova R, Zhang E, et al. Evaluation of Liver And Plasma HCV RNA Kinetics And Telaprevir Levels In Genotype 1 HCV Patients Treated With Telaprevir (TVR) Using Serial Fine Needle Aspirates (FNA). 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

7. Dierynck I, De Meyer S, Thys K, et al. Deep Sequencing of the HCV NS3/4A Region Confirms Low Prevalence of Telaprevir-resistant Variants Both at Baseline and End of Study. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract.

8. Incivo(R) Summary of Product Characteristics, updated 2011

9. 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.

10. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission

11. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011; 55: 245-264.

12. WHO. State of the art of vaccine research and development. Viral Cancers. Available from http://www.who.int/vaccine_research/documents/Viral_Cancers.pdf).

13. Mühlberger, N 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.

14. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Review of Vaccines 2008;7(7): 915-923.

15. 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.

16. The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20] Available from: http://www.hepctrust.org.uk/treat ment/potential-new-drugs/Drugs+that+target+the+virus.

Contact:

Ronan Collins, +44 (0)7876 257 746

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