Medivir Announces That Simeprevir (TMC435) Data Will Be Presented at the Upcoming AASLD Meeting

Update: Olysio (simeprevir) Now FDA Approved - November 22, 2013

STOCKHOLM--(BUSINESS WIRE)--Oct 1, 2012 - Regulatory News: Medivir AB (STO:MVIRB), announced today that four abstracts related to simeprevir (TMC435), have been accepted for presentation at the 63nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from November 9-13 in Boston, USA.

Simeprevir is a once daily potent HCV NS3/4A protease inhibitor in phase III clinical development for the treatment of chronic hepatitis C jointly developed by Medivir and Janssen Research & Development Ireland (Janssen).

AASLD PRESENTATIONS

Two of the abstracts will be presented as oral presentations and two as posters at the Hynes Convention Center in Boston.

ORAL PRESENTATIONS

Parallel Session 12, HCV New Agents: Hard to Treat Patients, Hynes Ballroom B & C, November 11, 16:45-18:15

 

  • Efficacy and tolerability of TMC435 150 mg once daily with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials) Fred Poordad, Michael W. Fried, Stefan Zeuzem, Peter Ferenci, Oliver Lenz, Rekha Sinha, Katleen Callewaert, Monika Peeters, Maria Beumont-Mauviel
  • No clinically significant interaction between the investigational HCV protease inhibitor TMC435 and the immunosuppressives cyclosporine and tacrolimus Sivi Ouwerkerk-Mahadevan, Alexandru Simion, Steven Mortier, Monika Peeters, Maria Beumont Mauviel

POSTER PRESENTATIONS

Clinical HCV 1, Poster Hall, November 11, 08:00-17:30

 

  • Safety and tolerability of TMC435 in combination with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naïve and -experienced patients (Phase IIb PILLAR and ASPIRE trials) Michael W. Fried, Fred Poordad, Stefan Zeuzem, Peter Ferenci, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Monika Peeters, Rekha Sinha, Maria Beumont-Mauviel
  • No pharmacokinetic interaction between the investigational HCV protease inhibitor TMC435 and an oral contraceptive containing ethinylestradiol and norethindrone Sivi Ouwerkerk-Mahadevan, Maria Beumont-Mauviel, Kurt Spittaels, Alexandru Simion, Monika Peeters

The abstracts have been published today and can be accessed on the AASLD website: http://www.aasld.org.

About Simeprevir (TMC435)

Simeprevir is a once daily potent HCV NS3/4A protease inhibitor jointly developed by Medivir and Janssen Research & Development Ireland (Janssen) to treat chronic hepatitis C virus infections.

Simeprevir is being developed both in combination with PegIFN/RBV and in combination with other Direct-acting Antiviral (DAA) agents in an all oral Interferon (IFN) free regimen, with or without Ribavirin (RBV).

Simeprevir is currently being evaluated in three global phase III studies, QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior PegIFN/RBV-treatment. In parallel to these trials, phase III studies for simeprevir in Japan, in both treatment naive and treatment experienced hepatitis C genotype-1 infected patients, are ongoing.

In parallel with the ongoing global phase III-studies, simeprevir is currently in three phase II Interferon free trials with or without Ribavirin.

 

  • In the first trial simeprevir is evaluated in combination with GS7977 (Gilead) in null responder hepatitis C genotype-1 infected patients.
  • In the second trial simeprevir is evaluated in combination with daclatasvir (BMS) in treatment-naïve or previous null responder hepatitis C genotype-1 infected patients.
  • In the third trial simeprevir is evaluated in combination with TMC647055 (Janssen R&D) and ritonavir in low doses in treatment-naïve, relapser or null responder hepatitis C genotype-1 infected patients.

For additional information about simeprevir (TMC435) please see 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, or 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 (TMC435), a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Research & Development Ireland.

In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia and today Medivir has a broad product portfolio with prescription pharmaceuticals in the Nordics.

Medivir's first product, the unique cold sore product Xerese®/Xerclear®, is launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDuo in Europe, Japan and Russia.

Medivir's IPO was in 1996 and currently the company has around 180 employees.

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

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people's lives.

This information was brought to you by Cision http://www.cisionwire.com

Contact: Medivir
Direct: +46 8 440 6550
or
Rein Piir
EVP Corporate Affairs & IR
Mobile: +46 708 537 292
or
M:Communications
medivir@mcomgroup.com
Europe:
Mary-Jane Elliott
or Amber Bielecka
or Hollie Vile
+44(0)20 7920 2330

 

 

Posted: October 2012

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