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Date: 2013-02-24

Type of information: Granting of a patent

Product name: Olysio® (USA/EU)/Sovriad® (Russia)

Compound: simeprevir (TMC435)

Therapeutic area: Infectious diseases

Action mechanism:

direct-acting antiviral agent/enzyme inhibitor. Simeprevir is a once-daily investigational hepatitis C NS3/4A protease inhibitor in late phase III clinical development being jointly developed by Janssen R&D Ireland and Medivir AB to treat chronic hepatitis C virus infections.

Company: Janssen (J&J - USA)

Disease:

genotype 1 and 4 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis

Latest news:

* On May 16, 2014, J&J and Medivir have announced that simeprevir has been  approved in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection. The EC approval for simeprevir with PegIFN + RBV is based on a clinical trial programme involving three pivotal phase III studies, with over 1000 patients. The trials; QUEST-1, QUEST-2 and PROMISE, explored the use of simeprevir in combination with PegIFN/RBV in treatment-naïve patients and patients who have relapsed after prior interferon-base treatment. All three studies met their primary endpoints and demonstrated that simeprevir in combination with PegIFN/RBV, achieves significant cure rates when compared with PegIFN/RBV alone. The EC approval for the combination of simeprevir and sofosbuvir also contains the phase II study, COSMOS. This was based upon prior null responder and treatment-naïve patients.

* On March 24, 2014, Medivir has announced that the Russian Ministry of Health has approved Sovriad® (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Russia will be the first country within EMEA to gain access to simeprevir. Statistics provided by the World Health Organization in 2011 showed that Russia has the third-highest prevalence of HCV, with an estimated 3.7 million infected. Though exact data for current rates is not available, in January 2014 alone, there were 4.858 new cases of HCV diagnosed in Russia. This reflects an increase of 3.5 percent in comparison to January 2013.

* On 20 March 2014, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for Olysio®, 150 mg, hard capsules intended for the treatment of chronic hepatitis C (CHC). The benefits with Olysio® are its efficacy demonstrated in the treatment of chronic hepatitis C in adult patients when used in combination with other medicinal products. The most common side effects (incidence ? 5%) are were nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction. A pharmacovigilance plan for Olysio® will be implemented as part of the marketing authorisation. It is proposed that Olysio® be prescribed by physicians experienced in the treatment of chronic hepatitis C.

* On November 23, 2013, Medivir has announced that the FDA has approved simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with ribavirin. The approval of simeprevir in the USA is based on several studies of patients with CHC genotype 1 infection. These studies include treatment-naïve patients (QUEST-1 and QUEST-2), and patients who have failed prior treatment with pegylated interferon and ribavirin; in PROMISE (prior relapsers) and ASPIRE (prior non-responders). The USA approval triggers a milestone payment of €10m to Medivir. Simeprevir was also approved for the treatment of genotype 1 hepatitis C in Canada (trade name Galexos™) in November 2013.

* On October 24, 2013, Janssen Research & Development has announced that the Antiviral Drugs Advisory Committee of the FDA voted unanimously (19 to 0) to recommend approval of the investigational protease inhibitor simeprevir (TMC435) administered once daily as a 150 mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment naïve or who have failed previous interferon-based therapy. The FDA granted a Priority Review designation in May to the New Drug Application (NDA) filed by Janssen for simeprevir. The regulatory submission for simeprevir is supported in part by data from three pivotal Phase 3 studies - QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment - as well as data from the Phase 2b ASPIRE study in prior non-responder patients. Janssen R&D Ireland presented data from the QUEST-1 and QUEST-2 studies earlier this year at the 48th Annual Meeting of the European Association for the Study of the Liver (EASL) in Amsterdam, The Netherlands, and presented data from PROMISE at Digestive Disease Week 2013 (DDW) in Orlando, Florida. Data from ASPIRE were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in 2012.

* On October 22, 2013, Medivir has announced that the FDA’s Antiviral Drugs Advisory Committee is scheduled to meet on 24 October 2013 to review the application for simeprevir.

* On September 27, 2013, Medivir has reported that Janssen Pharmaceutical R&D Ireland has been informed by the Japanese Ministry of Health, Labour and Welfare (MHLW) that simeprevir (trade name Sovriad™) has been approved for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. The approval in Japan triggers a milestone payment of €5m to Medivir. In the CONCERTO clinical trials, simeprevir, as part of a regimen with pegylated interferon and ribavirin, demonstrated strong efficacy, with 89 percent of patients with previously untreated genotype 1 HCV infection achieving a sustained virological response (SVR). The primary endpoint in all clinical studies for simeprevir was a SVR 12 weeks after the last dose of treatment. In studies that included patients who had relapsed after stopping previous HCV treatment, results showed an SVR rate of 96 percent. These results were presented in June at The Japan Society of Hepatology.

* On May 13, 2013, Medivir and J&J have announced that the FDA has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435) administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins.

* On March 28, 2013, Janssen Research & Development has announced it has submitted a New Drug Application (NDA) to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients. The regulatory submission for simeprevir is supported in part by data from three pivotal Phase 3 studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. In each study, participants were treated with one 150 mg simeprevir capsule once daily for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks. Primary efficacy data from the Phase 3 studies will be presented at an upcoming medical meeting.

* On February 22, 2013, Medivir has announced that its partner Janssen now has submitted a regulatory application to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV. Simeprevir, an investigational NS3/4A protease inhibitor, is administered as a single once-daily pill for 12 weeks. The regulatory submission in Japan is supported by data from four Japanese phase III clinical studies of once-daily simeprevir administered with Peg-IFN and RBV. The filing of a regulatory application in Japan triggers a milestone payment of €5m to Medivir. Japan’s phase III clinical program for simeprevir consists of four studies in patients with genotype 1 HCV: CONCERTO-1 in treatment-naïve patients, CONCERTO-2 and -3 in prior non-responders or patients who relapsed after prior interferon-based treatment, and CONCERTO-4 using different pegylated interferon treatments in a broad patient population.

Patents:

Submission of marketing authorization application USA : 2013-03-28

Submission of marketing authorization application UE: 2013-04-24

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2013-11-23

UE authorization: 2014-05-16

Favourable opinion UE: 2014-03-20

Favourable opinion USA: 2013-10-24

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes