Janssen to present new simeprevir data at The International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL)

Presentations include late-breaking final results from the Phase 2 COSMOS study

CORK, Ireland--(BUSINESS WIRE)--New data from the clinical development programme for Janssen’s protease inhibitor simeprevir in the treatment of genotype 1 or genotype 4 chronic hepatitis C virus (HCV) in adult patients with compensated liver disease will be presented at The International Liver Congress™ of the European Association for the study of the Liver (EASL). The International Liver Congress™ 2014 will take place from April 9-13 in London.

Janssen will present eight oral and poster presentations spanning the company’s Phase 2 and Phase 3 development programme for simeprevir in treatment combinations with and without ribavirin and interferon. New analyses of data from the Phase 3 QUEST-1, QUEST-2 and PROMISE clinical trials of simeprevir in combination with pegylated interferon and ribavirin, as well as final data from the Phase 2 COSMOS study of simeprevir in combination with Gilead Sciences Inc.’s nucleotide inhibitor sofosbuvir, with and without ribavirin, will be presented during the Congress.

The data to be presented at the International Liver Congress™ 2014 include:

Late-Breaking Oral Presentation

• Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype 1 prior null-responder/treatment-naïve patients (COSMOS Study): primary endpoint (SVR12) results in patients with METAVIR F3-4 (Cohort 2)¹
  • Lead Author: Eric Lawitz; The Texas Liver Institute, University of Texas Health Science Center, San Antonio, USA

Oral Presentations

• Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 prior null responders with METAVIR F0-2: COSMOS Study Cohort 1 subgroup analysis²
  • Lead Author: Mark Sulkowski; Johns Hopkins University School of Medicine, Baltimore, USA
• Simeprevir with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in European patients who relapsed after previous interferon-based therapy: the PROMISE trial³
  • Lead Author: Xavier Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations

• Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naïve or treatment-experienced chronic HCV genotype-4 infected patients: SVR12 results of a Phase 3 trial (RESTORE Study)⁴
  • Lead Author: Christopher Moreno; ULB Hôpital Erasme, Brussels, Belgium
• Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve European patients in the QUEST-1 and QUEST-2 Phase 3 trials⁵
  • Lead Author: Graham R. Foster; Queen Mary’s, University of London, London, UK
• Simeprevir reduces time with peginterferon/ribavirin-induced symptoms and quality-of-life impairments: 72-week results from three Phase 3 studies⁶
  • Lead Author: Jane Scott; Janssen
• Virology analyses of simeprevir in Phase 2b and 3 studies⁷
  • Lead Author: Oliver Lenz; Janssen
• Deep sequencing analyses of minority baseline polymorphisms and persistence of emerging mutations in HCV genotype 1-infected patients treated with simeprevir⁸
  • Lead Author: Bart Fevery; Janssen

Full session details and data presentation listings for The International Liver Congress™ 2014 can be found at http://www.ilc-congress.eu.

About simeprevir

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment of chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV. Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C and The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic HCV. This application is under review by the EMA.

About hepatitis C

Hepatitis C (HCV) is a major global public health concern. It is a serious and complex blood-borne virus which manifests itself through complications of the liver. If left untreated, it can cause significant and potentially fatal damage to the liver including cirrhosis, leading to eventual transplantation. In Europe it is a leading cause of liver transplantation.⁹

The World Health Organisation (WHO) and the European Association for the Study of the Liver (EASL) estimate that 160 million people worldwide were chronically infected with HCV in 2011.¹⁰ The virus is responsible for 350,000 deaths globally¹¹ and 86,000 deaths in the European region each year.¹² As the disease is often asymptomatic in its early stages it can be difficult to diagnose and treat. Up to 90 percent of those with HCV do not clear the virus without treatment and become chronically infected.¹³ The WHO estimates that 20 percent of people with HCV will develop cirrhosis and, of those, up to 20 percent may progress to livercancer.¹⁴ Genotype 1 HCV is the most prevalent form of the virus worldwide¹⁵ and one of the most challenging to treat successfully.

About Janssen Pharmaceutical Companies

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 R&D Ireland is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

# # #

REFERENCES

¹ Lawitz M et al. The COSMOS cohort 2 study, abstract presented at the European Associate for the Study of the Liver (EASL) 2014.

² Sulkowski MS et al. The COSMOS study, abstract presented at the European Association for the Study of the Liver (EASL) 2014.

³ Forns X et al. The PROMISE study, abstract presented at the European Association for the Study of the Liver (EASL) 2014.

⁴ Moreno C et al. The RESTORE study, abstract presented at the European Association for the Study of the Liver (EASL) 2014.

⁵ Foster GR et al. The QUEST 1 and 2, abstract presented at the European Association for the Study of the Liver (EASL) 2014.

⁶ Scott J et al. Abstract presented at the European Association for the Study of the Liver (EASL) 2014.

⁷ Lenz et al. Abstract presented at the European Association for the Study of the Liver (EASL) 2014.

⁸ Fevery B et al. Abstract presented at the European Association for the Study of the Liver (EASL) 2014.

⁹ European Association for the Study of the Liver. EASL The Burden of Liver Disease in Europe. Available from http://www.easl.eu/assets/application/files/54ae845caec619f_file.pdf. Accessed March 2014.

¹⁰ 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.

¹¹ World Health Organisation. Hepatitis C. Fact sheet N. 164. Available at: http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed March 2014.

¹² Muhlberger M et al. HCV-related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health 2009;9:34.

¹³ World Health Organisations (WHO). “Hepatitis C: About HCV Infection.” Available at: www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html Accessed March 2014.

¹⁴ World Health Organisation. Hepatitis C. Available at: http://www.who.int/csr/disease/hepatitis/Hepc.pdf. Accessed March 2014.

¹⁵ Zein NN. Clinical Significance of Hepatitis C Virus Genotypes. Clin. Microbiol. Rev. April 2000;13(2):223-235.