Janssen to Discontinue Hepatitis C Development Program

Viral Hepatitis Research and Development to Focus on Addressing Significant Unmet Needs in Chronic Hepatitis B 

Janssen Sciences Ireland UC (Janssen), today announced a strategic decision to discontinue further development of the investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivirals - AL-335, odalasvir and simeprevir. The ongoing phase II studies with JNJ-4178 will be completed as planned, but there will be no additional development thereafter. This decision was made in light of the increasing availability of a number of highly effective therapies addressing the medical need in hepatitis C.

"Going forward, our hepatitis R&D efforts will focus on chronic hepatitis B, where a high unmet medical need still exists. Our scientists are energized by this challenge and our research ambition is to achieve a functional cure of hepatitis B which affects over a quarter of a billion people globally," said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Infectious Disease Therapeutics, Janssen. "At Janssen, we focus our research and development on areas of greatest unmet medical need where we can combine our excellent internal science with the best available external innovation to bring optimized solutions and maximum benefit to patients."

Janssen pioneered the advancement of the first innovations in hepatitis C for nearly a decade when it co-developed telaprevir, a first-in-class protease inhibitor used in combination therapy for the treatment of chronic hepatitis C virus.[1] In collaboration with Medivir AB, Janssen subsequently developed and launched the second generation protease inhibitor OLYSIO® (simeprevir),[2] which is approved in countries around the world.

Today, people living with hepatitis C have a much more diverse range of therapies available following a wave of innovative treatments securing approval. For most, the standard of care for hepatitis C therapy has a duration of 8-12 weeks offering a cure to around 92-100% of people treated.[3]

About Janssen

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com and follow us at @JanssenGlobal.

References

Janssen. INCIVO® Approved in Europe Offering High Cure Rates for Genotype-1 Chronic Hepatitis C Compared to Standard of Care. Available at: https://www.jnj.com/media-center/press-releases/incivo-telaprevir-approved-in-europe-offering-higher-cure-rates-for-genotype-1-chronic-hepatitis-c-compared-to-standard-treatment Last accessed: September 2017.

Janssen. OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C. Available at: https://www.jnj.com/media-center/press-releases/olysio-simeprevir-receives-fda-approval-for-combination-treatment-of-chronic-hepatitis-c Last accessed: September 2017.

European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2016. Journal of Hepatology. 2017: 66(1):153-194.