Janssen to Unveil New Hepatitis B and C Data at The International Liver Congress(TM) 2016 of the European Association fo

CORK, Ireland, March 30, 2016 /PRNewswire/ --

Includes several late breaking and oral presentations from across R&D pipeline  

Highlights potential of R&D pipeline to deliver several new hepatitis B and C

regimens 

Janssen Sciences Ireland UC and certain Janssen affiliates* today announced it will present thirteen abstracts featuring new data on an investigational regimen for treatment of hepatitis B virus (HBV) and approved and investigational regimens for the treatment of hepatitis C virus (HCV) at the upcoming International Liver Congress(TM) of the European Association for the Study of the Liver (EASL 2016). The data to be presented is a reflection of the Janssen Pharmaceutical Companies' ongoing commitment to make hepatitis history by contributing through our research efforts to the elimination of viral hepatitis as a global public health concern.

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"Despite recent advances, the global impact of viral hepatitis remains far reaching with significant unmet needs yet to be addressed. We have come a long way in developing cures for hepatitis C, but further innovation is needed to deliver one treatment suitable for all patient types," said Lawrence M. Blatt, PhD, Global Therapeutic Area Head Infectious Diseases and Vaccines, Janssen Research & Development, LLC. "Chronic hepatitis B is a potentially fatal liver disease that requires life-long treatment. There remains no known cure which represents an unmet medical need and we are excited by the opportunity to fully leverage our expertise in this critical disease area in order to bring potentially new treatments to patients".

Data from Janssen's hepatitis B and C portfolio includes a late breaking abstract on NVR 3-778, a potentially first-in-drug-class HBV capsid assembly inhibitor in treatment-naive HBeAG--positive patients, which is also to be featured as part of the official congress press programme.

Late breaking data for the Phase 3 PLUTO trial with Janssen's protease inhibitor, simeprevir plus sofosbuvir for patients with HCV genotype 4 infection will also be presented. Alongside this, several other Phase 2 and 3 studies which evaluate the efficacy and tolerability for simeprevir in a range of adult patients with varying stages of chronic hepatitis C will be presented.

Further data on several early-stage investigational regimens in chronic hepatitis C, including new data on Janssen's nucleotide polymerase inhibitor, AL-335, which is currently in a Phase 2a study (NCT02569710) in combination with odalasvir (also called ACHN-3102) and simeprevir, along with Phase 1 data for its nucleotide polymerase inhibitor, JNJ-54257099 will be presented.

Below is a full list of the data to be presented at the International Liver Congress (TM) 2016. Full poster and oral presentation details can be accessed via the congress website at: https://events.easl.eu/EventProgramme/IL... :

Abstracts in Hepatitis C 

Simeprevir

- LBP516: Simeprevir plus sofosbuvir for hepatitis C virus genotype 4 infection: a

Phase 3, open-label study  

Late-breaking poster presentation, Thursday 14 April at 08:00 and Saturday 16 April at 18:00

Lead Author: Maria Buti, Hospital Vall d'Hebron and Centro de Investigacion Biomedica en Red en Enfermedades Hepaticas y Digestivas (CIBERehad), Barcelona

-  SAT-264: Pharmacokinetic interactions between simeprevir and ledipasvir in

treatment-naive hepatitis C virus genotype 1-infected patients without cirrhosis

treated with a simeprevir/sofosbuvir/ledipasvir regimen 

Poster presentation, Saturday 16 April, 08:00 - 18:00, Hall 8.1

Lead Author: S. Bourgeois, Department of Internal Medicine, ZNA Ster, Antwerp 

-  THU-215: Deep sequencing results from the Phase 2 IMPACT study of simeprevir in

combination with daclatasvir and sofosbuvir in treatment-naive and -experienced

patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated

liver disease 

Poster presentation, Thursday 14 April, 08:00 - 18:00, Hall 8.1  

Lead Author: C. Sarrazin, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany

-  THU-214: Consistent simeprevir resistance profile in hepatitis C virus genotype

1-infected patients failing simeprevir interferon-free compared with

interferon-containing regimens  

Poster presentation, Thursday 14 April, 08:00 - 18:00, Hall 8.1 

Lead Author: B. Fevery Janssen Infectious Diseases BVBA, Beerse, Belgium

-  SAT-167: Effectiveness of simeprevir-containing regimens among patients with

chronic hepatitis C virus in various US practice settings: The SONET study

Poster presentation, Saturday 16 April, 08:00 - 18:00, Hall 8.1Lead Author: I. Alam, Austin Hepatitis Center, Austin, TX, USA

-  FRI-457: Efficacy and safety of simeprevir and sofosbuvir with and without

ribavirin for 12 weeks in subjects with recurrent genotype 1 hepatitis C

post-orthotopic liver transplant: The GALAXY study

Poster presentation, Friday 15 April, 08:00 - 18:00, Hall 8.1

Lead Author: J.G. O'Leary, Baylor University Medical Center, Dallas, TX, USA

-  SAT-130: Efficacy and tolerability of simeprevir and daclatasvir for 12 or 24

weeks in HCV genotype 1b-infected treatment-naive patients with advanced fibrosis or

compensated cirrhosis

Poster presentation, Saturday 16 April, 08:00 - 18:00, Hall 8.1Lead Author: C. Hezode, Department of Hepatology and Gastroenterology, Hopital Henri Mondor, Universite Paris-Est, France

-  SAT-162: Effectiveness of simeprevir treatment for hepatitis C in real practice:

preliminary results from the STIly Italian observational study

Poster presentation, Saturday 16 April, 08:00 - 18:00, Hall 8.1

Lead Author: G.B Gaeta, Seconda Universita di Napoli, Napoli

-  SAT-212: Safety of simeprevir-based treatment for hepatitis C in real practice:

preliminary results from the STIly observational study

Poster presentation, Saturday 16 April, 08:00 - 18:00, Hall 8.1

Lead Author: M. Colombo, Ospedale Maggiore Policlinico, Milano

JNJ-54257099

-  THU-261: Preclinical characterization of JNJ-54257099 - a potent uridine-based

nucleotide polymerase inhibitor in Phase I clinical development for the treatment of

chronic hepatitis C 

Poster presentation, Thursday 14 April, 08:00 - 18:00, Hall 8.1

Lead Author: L. Tambuyzer, Janssen Infectious Diseases, BVBA, Beerse, Belgium

AL-335

- THU-228: AL-335, A once-daily pangenotypic nucleotide HCV polymerase inhibitor,

demonstrates potent antiviral activity over 7 days in treatment-naive genotype 1-4

patients

Poster presentation, Thursday 14 April, 08:00 - 18:00, Hall 8.1

Lead Author: E. Berliba, Internal Medicine, State Medical University "N. Testemitanu", Chisinau, Republic of Maldova

-  THU-226:  Pan-genotypic evaluation of AL-335, a clinical stage uridine analogue

inhibitor of hepatitis C virus polymerase

Poster presentation, Thursday 14 April, 08:00 - 18:00, Hall 8.1

Lead Author: J. Deval*

Abstracts in Hepatitis B 

NVR 3-778

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