November 12, 2013

Janssen Therapeutics EMEA
Posted on: 12 Nov 13

Beerse, Belgium (Nov. 11, 2013) Janssen R&D Ireland (Janssen) today announced the presentation of new data for the new generation protease inhibitor simeprevir (TMC435) in the treatment of genotype 1 chronic hepatitis C (HCV) in treatment-naïve and treatment-experienced adult patients with compensated liver disease. In analyses of the Phase 3 QUEST-1 and QUEST-2 studies in treatment-naïve patients and the Phase 3 PROMISE study in prior relapse patients, the efficacy of simeprevir was observed in HCV patients considered difficult to treat, including patients with the IL28B TT genotype and METAVIR scores of F4.

HCV is a major problem in the EMEA region, where an estimated 15 million people are living with the disease.1 Many patients living with chronic HCV are in need of treatment and the genotype of the virus often determines how efficacious treatment will be.2

"Patients with certain baseline characteristics can be more likely to fail or relapse after prior treatment," said Ira Jacobson, M.D., simeprevir clinical trial investigator, chief of the Division of Gastroenterology and Hepatology, Vincent Astor Distinguished Professor of Medicine, Weill Cornell Medical College, and attending physician, New York-Presbyterian Hospital/Weill Cornell Medical Center, United States. "The breadth of simeprevir data presented at The Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) reinforce the potential of simeprevir as an effective treatment option in multiple patient populations, including patients who are considered difficult to treat, and will offer important guidance to physicians once simeprevir is approved."

On October 24, the U.S. Antiviral Drugs Advisory Committee of the FDA voted unanimously (19-0) to recommend simeprevir 150mg capsules administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic HCV in adult patients with compensated liver disease. A Marketing Authorisation Application was submitted to the European Medicines Agency seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic HCV in April 2013. Simeprevir was approved in September 2013 in Japan, for the treatment of genotype 1 HCV. Simeprevir is also being studied in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action. UK/HCV/1113/0021

Pooled Analysis from QUEST-1 and QUEST-2 Confirms Clinical Benefit of Simeprevir in Sub-Populations of Patients (Abstract 1122)

In the Phase 3 QUEST-1 and QUEST-2 studies, 80% of treatment-naïve patients treated with simeprevir in combination with pegylated interferon and ribavirin achieved the primary endpoint of sustained virologic response 12 weeks after the end of treatment (SVR12) compared to 50% of patients treated with placebo plus pegylated interferon and ribavirin. The analysis, which included patients considered difficult to treat, found that 61% of patients with the IL28B TT genotype, 60% of patients with a METAVIR score of F4 and 75% of patients with genotype 1a HCV treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 21%, 34% and 47% of patients taking placebo plus pegylated interferon and ribavirin, respectively. Among patients with the genotype 1a Q80K polymorphism at baseline, 58% of patients treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 52% of patients treated with placebo in combination with pegylated interferon and ribavirin, but the difference was not statistically significant. 3% of patients treated with simeprevir discontinued treatment early due to an adverse event, compared to 2% of patients treated with placebo.

Analysis from PROMISE Reinforces Efficacy of Simeprevir in Sub-Populations of Patients (Abstract 1092)

In the pivotal Phase 3 PROMISE study, 79% of treatment-experienced HCV patients treated with simeprevir in combination with pegylated interferon and ribavirin who previously experienced a relapse after prior treatment with pegylated interferon-based therapy achieved the primary endpoint of SVR12 compared to 37% of patients treated with placebo plus pegylated interferon and ribavirin. In this sub-analysis, among patients considered difficult to treat, 65% of patients with the IL28B TT genotype, 74% of patients with a METAVIR score of F4 and 70% of patients with genotype 1a HCV treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 19%, 26% and 28% of patients taking placebo plus pegylated interferon and ribavirin, respectively. Among patients with the genotype 1a Q80K polymorphism at baseline, 47% of patients treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 30% of patients treated with placebo in combination with pegylated interferon and ribavirin. The most common adverse events in patients treated with simeprevir combined with pegylated interferon and ribavirin in the first 12 weeks were fatigue, headache and influenza-like illness.

"The data presented at AASLD offers further evidence of simeprevir’s efficacy in difficult to treat patient types," said Dr Maria Beumont, medical lead for simeprevir, Janssen. "Following the recent positive vote from the FDA’s Antiviral Drugs Advisory Committee to recommend approval of simeprevir, we look forward to making simeprevir available to patients living with chronic HCV in need of treatment in the near future, while we continue to evaluate the role of simeprevir as part of different HCV treatment combinations."

About Simeprevir

Simeprevir (TMC435) is a new generation NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, currently in Phase III development. Simeprevir works by blocking the viral protease enzyme that enables HCV to replicate in host cells. To date, more than 3,700 patients have been treated with simeprevir in clinical trials. UK/HCV/1113/0021 Page 3

Janssen Therapeutics EMEA, a division of Janssen Pharmaceutica NV has the commercialisation rights of simeprevir in Europe, Middle East & Africa. Medivir AB will commercialise the product in the Nordic countries.

In October, Janssen Pharmaceuticals, Inc. acquired the investigational compound GSK2336805, an NS5a replication complex inhibitor in Phase 2 development for the treatment of chronic HCV, from an affiliate of GlaxoSmithKline plc. Since being acquired, the compound has been renamed JNJ-56914845. Janssen Pharmaceuticals plans to initiate Phase 2 studies to evaluate the use of JNJ-56914845 in interferon-free combinations with simeprevir and TMC647055, the company’s non-nucleoside polymerase inhibitor, for the treatment of chronic HCV in adult patients with compensated liver disease.

For additional information about simeprevir clinical studies, please visit: https://www.clinicaltrialsregister.eu  or www.clinicaltrials.gov.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver that affects approximately 150 million people worldwide, and causes 350,000 deaths annually.2 In the European region alone the incidence rate is 8.7 per 100,000 and leads to 86,000 deaths annually.1

When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure. It is the leading cause of primary liver cancers in Europe.3

About Janssen R&D Ireland

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.

Janssen Therapeutics EMEA is fully dedicated to HCV and simeprevir. Janssen-Cilag International NV is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen-emea.com  and www.janssentherapeutics-emea.com   for more information. UK/HCV/1113/0021 Page 4

References

1. World Health Organisation Regional Office for Europe. Hepatitis data and statistics. http://www.euro.who.int/en/health-topics/communicable-diseases/hepatitis/data-and-statistics . Last accessed October 2013.

2. World Health Organisation Media Centre: Hepatitis C Fact Sheet No. 164; July 2013.

http://www.who.int/mediacentre/factsheets/fs164/en/ . Last accessed October 2013.

3. 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.

Editor's Details
Cendrine Banerjee-Quetel
GCI Health
http://GCI Health
+44 (0) 20 7072 4210
cendrine.banerjee-quetel@gcihealth.com

Last updated on: 12/11/2013

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