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

PR63937

CORK, Ireland, Mar. 30, 2016 /PRNewswire=KYODO JBN/ --

- 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.

     (Logo: http://photos.prnewswire.com/prnh/20140324/NY88746LOGO )

"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/ILC2016/POSTER.aspx :

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

     LBO6: NVR 3-778, a first-in-class HBV core inhibitor, alone and in

combination with peginterferon (PEGIFN), in treatment-naive HBeAG-positive

patients: Early reductions in HBV DNA and HBeAG

Oral presentation is under embargo until Saturday 16 April, 07:00 CET

Lead Author: Man-Fung Yuen**

* Alios BioPharma, Inc. and Novira Therapeutics Inc. Both part of the Janssen

Pharmaceutical Companies

**Full session details and data presentation listings for The International

Liver Congress(TM) 2016 can be found at http://www.ilc-congress.eu.

Janssen in Viral Hepatitis  

At Janssen, our commitment is to make hepatitis history by contributing to the

elimination of viral hepatitis as global public health concern. Leveraging our

vast research and development experience in viral diseases, we have

co-developed two approved treatments for chronic hepatitis C (telaprevir,

simeprevir) and are striving to bring forth further transformational medical

innovations for chronic hepatitis B and C to improve the lives of all those

affected by viral hepatitis.

We are developing a new combination regimen in hepatitis C which has the

potential to treat and cure a broad range of people living with this disease.

And seek to overcome the treatment challenges in hepatitis B, such as the

requirement for people to require lifelong therapy, with the aim of developing

a functional cure.  

With goals like this, there's no time to waste. That is why we partner with

organizations around the world, connecting our own expertise with that of

others. Because, only together we can Make Hepatitis History.

About Hepatitis  

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause

of chronic liver disease, is the focus of a rapidly evolving treatment

landscape. Approximately 150 million people are infected with hepatitis C

worldwide and 350,000 people per year die from the disease globally. 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. Similarly,

chronic hepatitis B (HBV) causes approximately 650,000 deaths worldwide from

cirrhosis and liver cancer, with approximately 60 percent of hepatocellular

carcinoma attributed to hepatitis B infection. Current recommended therapies

are unable to cure the infection, requiring most people to continue treatment

for life.

About Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we are dedicated to addressing some of the most important unmet

medical needs 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. For more information, visit

http://www.janssen.com or follow @JanssenGlobal.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the

Private Securities Litigation Reform Act of 1995 regarding product development.

The reader is cautioned not to rely on these forward-looking statements. These

statements are based on current expectations of future events. If underlying

assumptions prove inaccurate or known or unknown risks or uncertainties

materialize, actual results could vary materially from the expectations and

projections of Janssen Sciences Ireland UC, any of the other Janssen

Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties

include, but are not limited to: challenges inherent in product research and

development, including uncertainty of clinical success and obtaining regulatory

approvals; uncertainty of commercial success; competition, including

technological advances, new products and patents attained by competitors;

challenges to patents; changes to applicable laws and regulations, including

global health care reforms; and trends toward health care cost containment. A

further list and description of these risks, uncertainties and other factors

can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal

year ended January 3, 2016, including in Exhibit 99 thereto, and the company's

subsequent filings with the Securities and Exchange Commission. Copies of these

filings are available online at http://www.sec.gov, http://www.jnj.com or on

request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or

Johnson & Johnson undertakes to update any forward-looking statement as a

result of new information or future events or developments.

Source: Janssen Sciences Ireland UC