Janssen Highlights Hepatitis C Virus Development Programme at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL)

Presentations include late-breaking final results from the Phase 3 OPTIMIST trials and interim results from the Phase 2 IMPACT trial of simeprevir▼

CORK, Ireland--(BUSINESS WIRE)--Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) taking place in Vienna from April 22-26. Early-stage data on the investigational nucleotide analog polymerase inhibitors AL-335 and AL-516, which were recently obtained through Janssen’s acquisition of Alios BioPharma, will also be presented.

Several key presentations will report on the efficacy and tolerability of simeprevir in interferon-free combination regimens in Phase 2, Phase 3 and real-world clinical settings.

“Hepatitis C remains a serious health problem. The breadth of data we are presenting at The International Liver Congress™ reinforces our commitment to reducing the significant burden of this infectious disease around the world,” said Gaston Picchio, hepatitis disease area leader, Janssen. “Janssen has an extensive and ongoing clinical trial programme for hepatitis C, including confirmatory and new exploratory studies, and we look forward to sharing these results. We remain focused on investigating alternative and more immediate treatment options for patients with a high unmet need.”

A total of 14 company-sponsored abstracts supporting Janssen’s marketed and investigational therapies for HCV will be presented, including three abstracts on simeprevir accepted as late-breaking presentations. The scope and rigor of these data underscore Janssen’s commitment to being a positive catalyst in the fight against this serious public health threat.

“These data highlight the strength of our commitment to advancing research in the area of viral hepatitis,” said Lawrence M. Blatt, Ph.D., global head therapeutics, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma. “We are delighted to present additional data for simeprevir in combination with other currently available therapeutic options alongside early-stage data for our nucleotide portfolio.”

Studies on Janssen’s HCV portfolio to be presented at The International Liver Congress™ 2015 include:

Late-Breaking Poster Presentations

All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.

• A Phase 3, randomised, open-label study to evaluate the efficacy and safety of 12 and 8 weeks of simeprevir (SMV) plus sofosbuvir (SOF)▼ in treatment-naïve and -experienced patients with chronic HCV genotype 1 infection without cirrhosis: The OPTIMIST-1 study¹
  • Abstract LP14
  • Lead Author: P. Kwo; Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, IN, USA

• A Phase 3, open-label, single-arm study to evaluate the efficacy and safety of 12 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve or -experienced patients with chronic HCV genotype 1 infection and cirrhosis: The OPTIMIST-2 study²
  • Abstract LP04
  • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA

• Simeprevir (SMV) plus daclatasvir (DCV)▼ and sofosbuvir (SOF) in treatment-naïve and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease: Interim results from the Phase 2 IMPACT study¹
  • Abstract LP07
  • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA

Oral Presentation

• On-treatment virologic response and tolerability of simeprevir, daclatasvir and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation (OLT): Interim data from the Phase 2 SATURN Study¹
  • Abstract 0004: Thursday 23 April, 16:45 – 17:00, Hall D
  • Lead Author: X. Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations

All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.

• Significant drug-drug interaction between simeprevir and cyclosporine A but not tacrolimus in patients with recurrent chronic HCV infection after orthotopic liver transplantation: The SATURN study¹
  • Abstract P0834
  • Lead Author: S. Ouwerkerk-Mahadevan; Janssen Research & Development, Beerse, Belgium
• Deep sequencing analyses in HCV genotype 1-infected patients treated with simeprevir plus sofosbuvir with/without ribavirin in the COSMOS study⁶
  • Abstract P0780
  • Lead Author: B. Fevery; Janssen Infectious Diseases BVBA, Beerse, Belgium
• Effectiveness of simeprevir (SMV)-containing regimens among patients with chronic hepatitis C virus (HCV) in various U.S. practice settings: Interim analysis of the SONET study⁷
  • Abstract P0826
  • Lead Author: I. Alam; Austin Hepatitis Center, Austin, TX, USA
• Study protocol for a partly randomised, open-label Phase 2a trial of once-daily simeprevir combined with sofosbuvir for the treatment of HCV genotype 4-infected patients with or without cirrhosis (OSIRIS)⁸
  • Abstract P1346
  • Lead Author: M. El Raziky, Departments of Pediatrics, Cairo University, Cairo, Egypt
• Baseline factors associated with increased SVR rates in 123 treatment-naïve chronic HCV genotype 1 patients treated with a shortened 12-week simeprevir plus pegylated interferon and ribavirin regimen: A multivariate analysis⁹
  • Abstract P0792
  • Lead Author: T. Asselah, Beaujon Hospital, University of Paris, France
• Clinical characteristics and outcomes of chronic hepatitis C (CHC) patients treated with newer direct-acting antiviral (DAA)-based regimens from a large U.S. payer perspective¹⁰
  • Abstract P0852
  • Lead Author: N. Tandon; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
• A descriptive analysis of a real-world population with chronic hepatitis C (CHC) treated with simeprevir (SMV)-and/or sofosbuvir (SOF)-based regimens: Findings from a U.S. payer database¹¹
  • Abstract P0827
  • Lead Author: J.B. Forlenza; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
• Real world effectiveness and cost of simeprevir- and/or sofosbuvir-based HCV treatments: $175,000 per SVR12¹²
  • Abstract P0881
  • Lead Author: K. Bichoupan; Division of Liver Diseases, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY, USA

Alios BioPharma Poster Presentations

• Derisking the potential for mitochondrial toxicity of nucleoside analogs¹³
  • Abstract P0679
  • Lead author: Z. Jin; Alios BioPharma, San Francisco, CA, USA
• Preclinical characterization of AL-335, a potent uridine based nucleoside polymerase inhibitor for the treatment of chronic hepatitis C¹⁴
  • Abstract P0682
  • Lead Author: H. Tan; Alios BioPharma, San Francisco, CA, USA

Full session details and data presentation listings for The International Liver Congress™ 2015 can be found at http://www.ilc-congress.eu.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is a major global public health concern. Approximately 170 million people are infected with hepatitis C worldwide¹⁵ and 350,000 people per year die from the disease globally¹⁶ with 86,000 deaths in the European region each year.¹⁷ 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.¹⁸

About Janssen’s HCV Development Programme

The goal of the Janssen HCV clinical development programme is to provide physicians with multiple treatment options in order to offer patients the best possible chance at successful therapy.

Ongoing studies focus on the investigation of the NS3/4A protease inhibitor simeprevir in a number of different treatment combinations and HCV patient populations, including those who are difficult to cure.

Janssen’s HCV pipeline also includes JNJ-56914845, an investigational NS5A replication complex inhibitor currently in Phase 2 studies, and following the acquisition of Alios BioPharma by Johnson & Johnson in November 2014, AL-335, a uridine based nucleotide analog in Phase 1 development, and AL-516, a guanosine based nucleotide analog NS5B polymerase inhibitor in pre-clinical development.

These compounds are being developed with the express intent of targeting critical steps of the hepatitis C virus replication cycle.

About Simeprevir (OLYSIO^®)

Simeprevir is an NS3/4A protease inhibitor which has been developed by Janssen Sciences Ireland UC in collaboration with Medivir AB.

In November 2013, simeprevir was approved by the U.S. Food & Drug Administration and, in May 2014, it was granted marketing authorisation by the European Commission. Subsequent marketing authorisations have followed in several other countries around the world. Indications vary by market.

Janssen is responsible for the global clinical development of simeprevir and has exclusive,worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV.

About Janssen Pharmaceutical Companies of Johnson & Johnson

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.

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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 R&D Ireland and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including the uncertainty of clinical success and of obtaining regulatory approvals; 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 December 28, 2014, 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 www.sec.gov, 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.

References

¹ P Kwo et al. The OPTIMIST-1 study, abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

² Lawitz M et al. The OPTIMIST-2 study, abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

³ Lawitz M et al. The IMPACT study, abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

⁴ Forns X et al. The SATURN study, abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

⁵ Ouwerkerk-Mahadevan, S et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

⁶ Fevery, B et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

⁷ Alam, I et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

⁸ El Raziky, M et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

⁹ Asselah, T et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

¹⁰ Tandon, M et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

¹¹ Forlenza, J.B. et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

¹² Bichoupan, K et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

¹³ Jin, Z et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

¹⁴ Tan, H et al. Abstract presented at the European Associate for the Study of the Liver (EASL) 2015.

¹⁵ World Health Organisation, Hepatitis C. Available at: http://www.who.int/csr/disease/hepatitis/Hepc.pdf Last accessed April 2015.

¹⁶ World Health Organisation. Hepatitis C. Fact sheet N. 164. Available at: http://www.who.int/mediacentre/factsheets/fs164/en/. Last accessed April 2015.

¹⁷ 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.

April 2015
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