Johnson & Johnson
Dec 17, 2010

Janssen Seeks European Marketing Authorization for Investigational Hepatitis C Treatment Telaprevir

Beerse, Belgium, 17 December, 2010 - Janssen-Cilag International NV today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for telaprevir, an investigational, oral, direct-acting antiviral for the treatment of chronic genotype 1 hepatitis C virus1 (HCV), the most common form of the virus. Telaprevir is a potent and selective protease inhibitor (PI), which when combined with pegylated-interferon and ribavirin (the current treatment standard), shows activity in patients that are new to treatment and who have been previously treated but were not cured, including partial responders, relapsers and those who have had little or no response (null responders) to the current standard of treatment.

The EMA has accepted telaprevir for accelerated assessment, which is granted to quicken access to innovative, new medicines of major public-health interest. Tibotec BVBA, a global research and development company with specific experience in virology, is developing telaprevir in collaboration with Vertex Pharmaceuticals. Tibotec BVBA is an affiliate company of Janssen.

"The EMA submission for telaprevir is a landmark in the treatment of HCV and demonstrates our dedication to addressing unmet medical needs by developing innovative treatments for infectious diseases," said Johan Van Hoof, Global Therapeutic Area Head Infectious Diseases and Vaccines at Janssen. "Above all, it is an important step towards making telaprevir available to people living with HCV."

It is estimated that 170 million people are living with HCV around the world2, including more than five million in Europe.3 Chronic HCV can result in serious long-term health problems, and an estimated 30 percent of patients will develop progressive liver disease, including cirrhosis (damage and scarring of the liver), which places them at risk for liver insufficiency and liver cancer.4 HCV is the most common cause of liver transplant in Europe.5 The current standard of care for HCV genotype 1 patients, pegylated-interferon and ribavirin, is administered for 48 weeks and only 40 to 50 percent of genotype 1 patients achieve a sustained virologic response (SVR), defined as achieving undetectable levels of the virus in the blood for six months after completion of treatment, and considered an indicator of cure. Re-treatment with pegylated-interferon and ribavirin in patients who have previously failed this treatment shows only limited success. 6,7

The EMA submission is supported by results from three phase 3 studies, which compared telaprevir in combination with the current standard of treatment to the current standard of treatment alone in HCV genotype 1 patients. Results were very positive:

"Current treatment for hepatitis is lengthy and only effective for approximately half of treatment-naïve patients, and even fewer patients who failed previous treatment," commented Stefan Zeuzem, Professor of Medicine and Chief, department of medicine, J W Goethe University Hospital, Frankfurt. "If approved, telaprevir would help to significantly improve cure rates and shorten treatment duration for many people living with HCV, compared to current standard treatment."

About the Telaprevir Development Program
To date, more than 2,500 people with HCV genotype 1 have received telaprevir-based therapy (telaprevir combined with the current standard of treatment) as part of Phase 2 studies and the Phase 3 ADVANCE, ILLUMINATE and REALIZE trials.8,9,10 The telaprevir clinical development program is the largest conducted to date for any investigational direct-acting antiviral hepatitis C therapy.

Telaprevir is being developed by Tibotec BVBA, an affiliate company of Janssen, in collaboration with Vertex Pharmaceuticals and Mitsubishi Tanabe Pharma for the treatment of genotype 1 HCV in combination with pegylated-interferon and ribavirin in both patients who have failed prior treatment and those who have never been treated. Tibotec BVBA has the commercialisation rights for telaprevir in Europe, Latin America, the Middle East, Africa, India, Australia and New Zealand, pending approval by the respective regulatory authorities. Vertex will commercialise telaprevir in the U.S., Canada and Mexico and Mitsubishi Tanabe Pharma has rights to commercialise telaprevir in Japan and certain Far East countries.

About Tibotec BVBA
Tibotec BVBA is a global pharmaceutical and research development company. The Company's main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and HCV drugs, and anti-infectives for diseases of high unmet medical need.

About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, HCV and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.

More information can be found at www.janssen-emea.com.

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References

1 The Hepatitis C Trust. The hepatitis C virus: Genotypes of HCV. [cited 2010 Nov 11] Available from: http://www.hepctrust.org.uk/hepatitis-c/The+hepatitis+C+virus.
2 World Health Organization. Hepatitis C, surveillance and control. [cited 2010 November 29] Available from: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html.
3 Biggins SW. Treatment of recurrent hepatitis C after liver transplantation. Infect Dis Clin North Am. 2006 Mar;20(1):155-74.
4 Buskila D. Hepatitis C Associated Rheumatic Disorders. Rheum Dis Clin N Am. 2009;35:111-123.
5 Lang K, Weiner DB. Expert Rev Vaccines. "Immunotherapy for HCV infection: next steps." 2008;7(7): 915-923.
6 The Hepatitis C Trust. Introduction: Potential New Drugs. [cited 2010 Oct 19] Available from: http://www.hepctrust.org.uk/treatment/potential-new-drugs.
7 The Hepatitis C Trust. Treatment: Retreatment. [cited 2010 Oct 19] Available from: http://www.hepctrust.org.uk/treatment/Retreatment.
8 McHutchison, J, Jacobson, I, and Dusheiko, G et al. Telaprevir in Combination with Peginterferon and Ribavirin in Genotype 1 HCVTreatment-Naive Patients: Final Results of Phase 3 ADVANCE Study. Presented at AASLD 2010. Boston, USA.
9 Sherman, K, Flamm, S, and Afdhal, N et al. Telaprevir in Combination with Peginterferon and Ribavirin in Genotype 1 HCVTreatment-Naive genotype 1 HCV Patients who achieved an Extended Rapid Viral Response: Final Results of Phase 3 ILLUMINATE Study. Presented at AASLD 2010, Boston, USA.
10 Janssen data on file.