Janssen to Discontinue Hepatitis C Development Program

PR69992

CORK, Ireland, Sep. 11, 2017 /PRNewswire=KYODO JBN/ --

•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.

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

"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

1.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.

2.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.

3.European Association for the Study of the Liver. EASL Recommendations on

Treatment of Hepatitis C 2016. Journal of Hepatology. 2017: 66(1):153-194.

SOURCE: Janssen