Regulatory Application has now been filed for Simeprevir (TMC435) in Japan for the treatment of genotype 1 hepatitis C patients

Stockholm, Sweden — Medivir AB (OMX: MVIR) today 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.

Approximately 1.5 to 2 million people in Japan are infected with HCV. After infection with HCV occurs, the infection persists in about 70 percent of cases, leading to the onset of chronic hepatitis C. Continued inflammation can cause liver fibrosis to progress into liver cirrhosis and liver cancer.1 In Japan, approximately 35,000 people die from liver cancer each year and HCV has been found to be the cause in about 80 percent of cases.2

”This is a major event for simeprevir on its way to the different global registrations. For us as an R&D driven company it is one of the most exciting milestones that we have experienced”, comments Maris Hartmanis, CEO of Medivir.         

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292.

About Simeprevir (TMC435)
Simeprevir is a once-daily potent investigational hepatitis C 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. Simeprevir is being investigated in combination with Peg-IFN/RBV in phase III trials and is also being evaluated with Direct-acting Antiviral (DAA) agents in four other phase II interferon-free combinations both with and without ribavirin.

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.

Global phase III studies of simeprevir in combination with Peg-IFN/RBV include the following studies:

• QUEST-1 and QUEST-2 in treatment-naïve patients.
• PROMISE in patients who have relapsed after prior interferon-based treatment.
• ATTAIN in prior null-responder patients and studies in Japanese HCV genotype 1 patients.

In parallel to these trials, phase III studies for simeprevir are ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected patients and in HCV genotype 4 patients.

Simeprevir is also being studied in phase II interferon-free trials both with and without ribavirin:

• Simeprevir in combination with Gilead Sciences’ sofosbuvir (GS7977) in hepatitis C genotype 1 treatment-naïve or prior null responder patients.
• Simeprevir in combination with BMS’s, daclatasvir in hepatitis C genotype 1 treatment-naïve or prior null responder patients.
• Simeprevir in combination with Janssen’s TMC647055 and low dose ritonavir in hepatitis C genotype 1 treatment-naïve, prior relapser or null responder patients.
• Simeprevir in combination with Vertex’s VX-135 in hepatitis C genotype 1 treatment-naïve patients to commence in 2013.

It was also recently announced plans to initiate a phase IIa trial of an investigational interferon-free regimen with simeprevir, TMC647055 and Idenix’s IDX719, a once-daily NS5A inhibitor, with and without ribavirin.

For additional information about Simeprevir, please visit www.clinicaltrials.gov

About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The World Health Organization estimates that nearly 170 million people worldwide, approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC (Centers for Disease Control and Prevention) has reported that more than three million people in the United States are chronically infected with HCV.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases.

Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir, please visit the Company’s website: www.medivir.com

References:
1) "May 2012 Treatment Guidelines of Hepatitis C" edited by The Committee for Hepatitis Clinical Guidelines, Japan Society of Hepatology
2) "Latest Statistics on Cancer (2010 Updated Version)" by the Center for Cancer Control and Information Services, National Cancer Center