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Janssen Pharmaceutica

Janssen to Discontinue Hepatitis C Development Program

Ireland (ots/PRNewswire)

- 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 (http://www.twitter.com/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/inci
   vo-telaprevir-approved-in-europe-offering-higher-cure-rates-for-ge
   notype-1-chronic-hepatitis-c-compared-to-standard-treatment Last 
   accessed: September 2017.
2. Janssen. OLYSIO(TM) (simeprevir) Receives FDA Approval for 
   Combination Treatment of Chronic Hepatitis C. Available at: https:
   //www.jnj.com/media-center/press-releases/olysio-simeprevir-receiv
   es-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.

Contact:

Katie Buckley
+44-7971-956-179
kbuckle8@its.jnj.com

INVESTOR RELATIONS: Lesley Fishman
+1-732-524-3922
lfishma@its.jnj.com

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