Medivir announces Janssen decision to terminate its simeprevir license effective June 2018

Medivir announces Janssen decision to terminate its simeprevir license effective June 2018
Sun, Dec 10, 2017 11:30 CET

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that Janssen Pharmaceuticals Inc. (Janssen) has decided to terminate the license that it holds for simeprevir due to Janssen’s assessment of market demand. The termination of the license will become effective in June 2018 and Medivir will continue to receive royalties on any remaining sales of Olysio/Sovriad (simeprevir) that Janssen will make until that time. Medivir will seek to identify potential commercialization partners for specific territories where it believes there may be a market opportunity.

Medivir’s royalty on the global sales of simeprevir in the first three quarters of 2017 were SEK 13.7M, SEK 7.7M, and SEK 4.1M respectively.

http://news.cision.com/medivir/r/medivir-announces-janssen-decision-to-terminate-its-simeprevir-license-effective-june-2018,c2410803

Update on the Development of Simeprevir as Part of the Triple Combination With AL-335 and Odalasvir (JNJ-4178)

Update on the Development of Simeprevir as Part of the Triple Combination With AL-335 and Odalasvir (JNJ-4178)

STOCKHOLM, April 24, 2017 /PRNewswire/ --Medivir AB (Nasdaq Stockholm: MVIR) today communicates an update on the status of the development of JNJ-4178, the triple combination of simeprevir, odalasvir and AL-335, following The International Liver Congress™ 2017 of the European Association for the Study of the Liver (EASL), which was held in Amsterdam, on 19-23 April.

Data from an ongoing phase II study presented at The International Liver Congress™ 2017 demonstrate that this regimen has the potential to shorten treatment duration, offer high efficacy and is generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally. The three-drug regimen achieved 100% SVR12 for 6- and 8-week treatment duration in treatment-naïve, GT1, non-cirrhotic patients. The three-drug combination did not have sufficient efficacy in patients with HCV genotype 3 to justify further development in this patient population. All-oral combination regimens, containing odalasvir, AL-335 with or without simeprevir were generally safe and well tolerated. The safety and efficacy of JNJ-4178 in cirrhotic patients is currently under investigation as part of this phase II study. Further information on this trial can be found at www.clinicaltrials.gov (NCT02569710).
                          

Enrolment has recently been completed into the global phase IIb OMEGA-1 study of JNJ-4178. This open-label study is assessing the efficacy and safety of JNJ-4178 in non-cirrhotic patients with HCV genotypes 1, 2, 4, 5 and 6. Further information on the study can be found at www.clinicaltrials.gov (NCT02765490).

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Hep C 5-minute videos - Summary Of The International Liver Congress™ (ILC) 2017

Simeprevir/New Data Will Be Presented at Easl's International Liver Congress 2016

Medivir: New Data for Simeprevir Will Be Presented at Easl's International Liver Congress 2016
April 11, 2016 09:46 AM Eastern Daylight Time


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

Medivir (STO:MVIRB)

Medivir AB (Nasdaq Stockholm: MVIR) today informs that new clinical data for simeprevir, an NS3 / 4A protease inhibitor for the treatment of hepatitis C virus infection, will be presented by our partner Janssen Sciences Ireland UC (Janssen) in conjunction with The International Liver Congress ™ 2016 of the European Association for the Study of the Liver (EASL) in Barcelona, on 13-17 April. A total of nine presentations will be made, including one "late breaker" presentation. The presentations will cover the efficacy, safety and tolerability of simeprevir used as a component of various combination therapies in a number of different adult patient populations, and will be based on data from phase II and phase III studies and from on-going clinical use (so-called "real-world data").

Data presented at the International Liver Congress 2015 include:

Late-Breaking Poster Presentation

Simeprevir plus sofosbuvir for hepatitis C virus genotype 4 infection: a phase 3, open-label study.

· Abstract LBP516

· Lead Author: M. Buti; Hospital Vall d’Hebron and Centro Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain

Poster Presentations

Pharmacokinetic interactions between simeprevir and ledipasvir in treatment-naïve hepatitis C virus genotype 1-infected patients without cirrhosis treated with a simeprevir/sofosbuvir/ledipasvir regimen

· Abstract SAT-264

· Lead Author: S. Bourgeois, Department of Internal Medicine, ZNA Ster, Antwerp

Deep sequencing results from the Phase 2 IMPACT study of simeprevir in combination with daclatasvir and sofosbuvir in treatment-naïve and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease

· Abstract THU-215

· Lead Author: C. Sarrazin, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany

Consistent simeprevir resistance profile in hepatitis C virus genotype 1-infected patients failing simeprevir interferon-free compared with interferon-containing regimens

· Abstract THU-214

· Lead Author: B. Fevery, Janssen Infectious Diseases BVBA, Beerse, Belgium

Effectiveness of simeprevir-containing regimens among patients with chronic hepatitis C virus in various US practice settings: The SONET study

· Abstract SAT-167

· Lead Author: I. Alam, Austin Hepatitis Center, Austin, TX, USA

Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin for 12 weeks in subjects with recurrent genotype 1 hepatitis C post-orthotopic liver transplant: The GALAXY study

· Abstract FRI-457

· Lead Author: J.G. O'Leary, Baylor University Medical Center, Dallas, TX, USA

Efficacy and tolerability of simeprevir and daclatasvir for 12 or 24 weeks in HCV genotype 1b-infected treatment-naïve patients with advanced fibrosis or compensated cirrhosis

· Abstract SAT-130

· Lead Author: C. Hézode, Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, Université Paris-Est, France

Effectiveness of simeprevir treatment for hepatitis C in real practice: preliminary results from the STIly Italian observational study

· Abstract SAT-162

· Lead Author: G.B. Gaeta, Seconda Universita di Napoli, Napoli, Italy

Safety of simeprevir-based treatment for hepatitis C in real practice: preliminary results from the STIly observational study

· Abstract SAT-212

· Lead Author: M. Colombo, Ospedale Maggiore Policlinico, Milano, Italy

Details of all presentations for The International Liver Congress ™ 2016 are available at the conference website: http://www.ilc-congress.eu