April 20, 2012

Janssen launches EMEA division to market hepatitis C drug

Published: 20/04/2012

Janssen Pharmaceutica has set up a new division to market its hepatitis C product TMC435 to patients in Europe, the Middle East and Africa.

Janssen, which is itself a subsidiary of healthcare giant Johnson & Johnson (J&J), said the Janssen Therapeutics EMEA division will be based in Beerse, Belgium, and will bring together experts from across the region to tackle the disease.

At the heart of this will be the development and commercialisation of TMC435, an investigational protease inhibitor that the company is developing with its partner Medivir as a new class of hepatitis C treatment.

It is currently in late phase III clinical development in combination with current treatment option pegIFN/ribavirin.

Jane Griffiths, Janssen EMEA company group chair said: “The World Health Organization describes hepatitis C as a ‘viral time bomb’.

“That is why we have created a dedicated division, which will commercialise TMC435 and help meet hepatitis C patients’ needs. Janssen Therapeutics EMEA is on a mission to bring new options to successfully treat patients with this devastating disease.”

Outside the EMEA, J&J’s other subsidiary Tibotec plans to market the drug if approved.

The launch of Janssen Therapeutics EMEA coincides with European Association for the Study of the Liver (EASL) International Liver Congress 2012 in Barcelona.

At the congress, Janssen presented new retrospective analysis of phase III data for its other hepatitis C treatment Incivo (telaprevir).

The drug, which is approved in Europe to treat chronic hepatitis C in combination with pegIFN/ribavirin, demonstrated that a similar sustained virologic response (SVR) rate was achievable even if the dosage of ribavirin was lowered.

This could have benefits for people with hepatitis C, according to Janssen, as ribavirin is linked to incidents of anaemia in patients taken the combination of treatments.

Professor Mark Sulkowski, professor of medicine at Johns Hopkins University School of Medicine, Baltimore, said: “These results demonstrate that the reduction of ribavirin to help manage treatment-related anaemia when treating with telaprevir did not compromise the chance of clearing the virus.”

There will be an interview with Jane Griffiths in the May issue of Pharmaceutical Market Europe.

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