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.
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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.

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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

AASLD 2016 Once-Daily Simeprevir, AL-335, and Odalasvir Combination Safe, Effective

Once-Daily Simeprevir, AL-335, and Odalasvir Combination Safe, Effective
By Bryant Furlow November 13, 2016

BOSTON, MA—Once-daily-administered combination of the investigative direct-acting antivirals AL-335 and odalasvir (ODV), and simeprevir (SMV) is well tolerated in healthy volunteers, and is now under study among patients with hepatitis C virus (HCV), according to findings from an open-label Phase 1 study presented at The Liver Meeting® 2016.
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Additional updates @ MPR
Current updates: Conference Reports
Updates On This Blog: AASLD 2016

EASL/AASLD2016 - Achillion Reports 100% SVR In Phase2a Trial:Odalasvir, AL-335, and Simeprevir for Geno 1 Treatment-Naive

Achillion Announces 100% SVR Reported in Janssen’s Phase 2a Trial Evaluating Triple Combination of Odalasvir, AL-335, and Simeprevir for Genotype 1 Treatment-Naive HCV

New data released today in abstract for upcoming EASL / AASLD Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap For Cure -

- Janssen advancing triple combination into Phase 2b clinical trial -

NEW HAVEN, Conn., Sept. 09, 2016 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that new interim results from a phase 2a study being conducted by Alios BioPharma, Inc., part of the Janssen Pharmaceutical Companies (Janssen), were published as part of the abstracts released for the upcoming European Association for the Study of the Liver (EASL) Special Conference, September 23 - 24, 2016, in Paris, France.

This ongoing phase 2a study was designed to confirm the required dose and treatment duration for an all-oral combination regimen containing odalasvir (ODV) and AL-335 with or without simeprevir (SMV) for durations of eight or six weeks of treatment in treatment-naïve patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

“We are delighted by the significant progress Janssen has made in advancing the all-oral, short-duration treatment regimen of odalasvir, AL-335 and simeprevir and are impressed with the Phase 2a study results being presented. Based on these interim results, Janssen plans to advance a phase 2b program for the triple combination to further understand the potential of this 3DAA drug combination to shorten the duration of treatment for patients suffering from HCV,” commented Dr. Milind Deshpande, President and Chief Executive Officer of Achillion. “Despite recent therapeutic advances, we believe there remains a significant unmet need in addressing the global burden of hepatitis C virus in those living with the disease.”

Data included in the abstract were as of the time of submission in July 2016. Updated results, including sustained viral response 12 weeks after completion of therapy (SVR12) for all cohorts, are scheduled to be presented on Friday, September 23, 2016, in an ePoster entitled "Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection." Interim results from cohorts 1-4, summarized in the table below, showed that the triple combination regimen was highly effective and well tolerated in non-cirrhotic patients with GT1 HCV.

Table 1: Interim Phase 2a Results for Cohorts 1 – 4 

Cohort #	Dose			Dosing Duration (weeks)	Number (%) withundetectable* HCV RNA (EOT or SVR)
	AL-335 (mg QD)	ODV (mg)	SMV  (mg QD)
1	400	50 QD	100	8	20/20 (100%), SVR24
2	800	50 QOD	--	8	18/20 (90%), SVR12
3	800	50 QOD	75	8	20/20 (100%), SVR4
4	800	50 QOD	75	6	20/20 (100%), EOT

*Or below the limit of quantitation (N=2; Cohort 4 only)
EOT: end of treatment; QD: every day; QOD: every other day; RNA: ribonucleic acid

Summary of Phase 2a Study Design and Interim Results

This phase 2a study was designed to determine the pharmacokinetics, efficacy and safety of ODV and AL-335 with or without SMV, in treatment naïve patients with GT1 or 3 HCV infection for treatment durations of eight weeks or less.

Of the 20 patients treated in cohort 1, who received the triple combination of odalasvir (50mg QD), AL-335 (400mg QD) and simeprevir (100mg QD) for eight weeks (triplet, 8 weeks), 100 percent remained HCV RNA undetectable 24 weeks after completing therapy (SVR24). Additional patients were subsequently enrolled into two further cohorts (3 & 4), where they received adjusted doses of the same triplet combination for either eight or six weeks. In cohort 3 all were HCV RNA negative and remained HCV RNA undetectable 4 weeks after completing therapy (SVR4) and in cohort 4 all were HCV RNA negative (N=18) or below the limit of quantitation (N=2) at end of treatment. Of the 20 patients treated in cohort 2, who received the dual combination of odalasvir (50mg QOD) and AL-335 (800mg QD) for eight weeks (doublet, 8 weeks), 90 percent remained HCV RNA undetectable twelve weeks after completing therapy (SVR12).  

All-oral combination regimens, containing odalasvir, AL-335 with or without simeprevir were generally safe and well tolerated. The majority of adverse events (AEs) were mild, most commonly headache, fatigue, and upper respiratory tract infection. In cohort 1, there was a single serious adverse event (Mobitz Type 1 2^nd degree atrioventricular block), which was attributed to treatment. This ECG abnormality was not associated with clinical or echocardiographic abnormalities, and resolved following treatment discontinuation. No clinically significant laboratory abnormalities were observed. 

Ongoing Phase 2 Development Program

Based upon the interim results from the phase 2a study, which confirmed the required dose for each component and the treatment duration, the triple combination is being advanced into a phase 2b program consisting of once daily odalasvir 25mg, AL-335 800mg, and simeprevir 75mg. The development program will include two multi-center, randomized, open-label studies that will enroll treatment-naive and treatment-experienced non-cirrhotic patients chronically infected with hepatitis C virus genotypes 1, 2, 4, 5, and 6. These studies will be complemented by an expansion of the ongoing phase 2a study focusing on patients with or without compensated cirrhosis and on patients with HCV genotype 2 and 3 infection. The results from the phase 2 program will guide further development.  

Further information on this study can be found at www.clinicaltrials.gov. Study identifier: CT02765490.

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

 

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