Janssen to Discontinue Hepatitis C Development Program

J&J pulls plug on Medivir-Achillion hep C cocktail to focus on hep B
by Ben Adams
Why? The same reason others have dropped out of the development and sales race: There are too many good treatments and increasingly, those without the need for injection, which has seen domination from Gilead’s curative meds Sovaldi and Harvoni.
These meds, as well as others from Big Pharmas, can effectively cure the vast majority of patients with hep C in a few months; Gilead itself has been a victim of its own success, seeing tens of billions of dollars for its therapies after launch, but this started to quickly dwindle after patients no longer needed them.
Read more.....

Janssen to Discontinue Hepatitis C Development Program

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

CORK, Ireland, September 11, 2017 - 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. In collaboration with Medivir AB, Janssen subsequently developed and launched the second generation protease inhibitor OLYSIO(simeprevir),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.
http://www.publicnow.com/view/1FCF810BABD0E322CBD5D388A7B4D40496BD4A00?2017-09-11-13:00:07+01:00-xxx7233

J&J unit ends hepatitis C drug development in crowded market

(Reuters) - Janssen Sciences Ireland UC, a unit of Johnson & Johnson, said it would discontinue further development of its hepatitis C research, citing increased availability of a number of effective hepatitis C therapies.

Janssen said it would not continue the development of the investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivirals.

Read More -

http://in.reuters.com/article/us-johnson-johnson-hepatitis-c/jj-unit-ends-hepatitis-c-drug-development-in-crowded-market-idINKCN1BM0LL

Janssen has initiated phase IIb study of simeprevir, odalasvir and AL-335

Medivir announces that Janssen has initiated an open-label phase IIb study of the 3DAA combination of simeprevir, odalasvir and AL-335 (JNJ-4178)

November 28, 2016 02:51 AM Eastern Standard Time

STOCKHOLM--(BUSINESS WIRE)--Regulatory News:

Medivir AB (STO:MVIRB) today announces that a phase IIb open-label study of the combination of simeprevir, odalasvir and AL-335, also known as JNJ-4178, has been initiated by Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), in treatment-naive and treatment-experienced subjects with chronic hepatitis C virus infection without cirrhosis. This global, multi-center study includes clinical trial sites in North America, Europe and Asia and forms part of Janssen’s global development program for JNJ-4178.

The objectives of the phase IIb study are to investigate the efficacy, safety and pharmacokinetics of JNJ-4178/ AL-335 (800mg QD), odalasvir (25mg QD), and simeprevir (75mg QD) in treatment-naive and treatment-experienced non-cirrhotic subjects with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection.

Patients in the study will receive the triple combination for either six or eight weeks, and the primary efficacy endpoint will be the percentage of patients with a sustained virological response 12 weeks after the end of treatment (SVR12).

An ongoing phase IIa study is assessing the same triple combination in patients with or without compensated cirrhosis.

Further information on the trial planning and conduct can be found on www.clinicaltrials.gov with identifier NCT02765490.

Medivir is required under the Securities Markets Act to make the information in this press release public.

The information was submitted for publication at 8.30 CET on 28 November 2016.

About Medivir

Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

This information was brought to you by Cision http://news.cision.com

Janssen to Start a Phase IIb Study/Combinations of Simeprevir, Odalasvir and AL-335 for the Treatment of Hepatitis C

Study identifier: NCT02765490.
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) or AL-335 and ODV in the Treatment of Chronic Hepatitis C Infection

Janssen; Phase IIb Study of Combinations of Simeprevir, Odalasvir and AL-335 for the Treatment of Hepatitis C

Medivir AB (STO:MVIRB) today announces that Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies (Janssen), has decided to initiate a phase IIb study to investigate the efficacy, safety and pharmacokinetics of different treatment regimens of AL-335, odalasvir, and simeprevir in treatment-naïve and treatment-experienced patients with chronic Hepatitis C Virus (HCV) genotype 1-6 infection, with and without cirrhosis.
   

This global phase IIb study is a randomized, open-label, four-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor and simeprevir, an HCV NS3/4A protease inhibitor. Approximately 400 patients will be randomized to one of four treatment arms and receive once daily treatment for a duration of six or eight weeks. Patients in two of the four arms will receive AL-335, odalasvir and simeprevir, a compound jointly developed by Janssen Sciences Ireland UC and Medivir AB, while patients in the other two arms will receive only AL-335 and odalasvir. The primary endpoint of the study is the percentage of chronic HCV-infected subjects who achieve a sustained virologic response 12 weeks after the end of treatment (SVR12). The study is intended to start in June 2016 and the estimated date for completion is July 2017.

Further information about the study can be found at www.clinicaltrials.gov.

Study identifier: NCT02765490.

   

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 9.15 CET on 11 May 2016.

About Simeprevir (OLYSIO®)

   

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen Sciences Ireland UC and Medivir AB and indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease, including cirrhosis. 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 authorization held by Janssen-Cilag International NV. 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.

About Medivir    

Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

This information was brought to you by Cision http://news.cision.com

 

View source version on businesswire.com: http://www.businesswire.com/news/home/20160511005530/en/

Janssen Initiates Phase 2a HCV Study: AL-335, Odalasvir (ACH-3102), and Simeprevir for Genotype 1

Achillion Announces That Janssen Has Initiated a Phase 2a Study to Evaluate the Combination of AL-335, Odalasvir (ACH-3102), and Simeprevir for the Treatment of Genotype 1 Chronic HCV

By GlobeNewswire, October 16, 2015, 06:05:00 AM EDT

Once Daily Triple Direct-Acting Antiviral Regimen Will be Evaluated for Treatment Durations of Four, Six or Eight Weeks

NEW HAVEN, Conn., Oct. 16, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc.(Nasdaq:ACHN) announced today that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has initiated treatment in a phase 2a clinical trial to evaluate the safety, pharmacokinetics and efficacy of AL-335, odalasvir (also known as ACH-3102), and simeprevir in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection.

This phase 2a study is a randomized, open-label, three-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor, and simeprevir, an HCV NS3/4A protease inhibitor. Patients will be randomized to one of three treatment arms and receive once daily treatment for a duration of four, six or eight weeks. The primary objective of the study is to establish the safety of the treatment regimen with secondary endpoints consisting of pharmacokinetics, the proportion of subjects achieving sustained viral response (SVR), and the effect on the viral resistance profile after treatment. The study is expected to enroll approximately 60 patients across the three treatment arms.

As previously announced on May 19, 2015, Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir.

Further information about the study can be found at www.clinicaltrials.gov. Study identifier: NCT02569710.

Read more: http://www.nasdaq.com/press-release/achillion-announces-that-janssen-has-initiated-a-phase-2a-study-to-evaluate-the-combination-of-20151016-00108#ixzz3okSzohFn