Janssen Creates new Division to Launch TMC435 and Help Conquer Hepatitis C in EMEA

Today sees the launch of Janssen Therapeutics EMEA, a division of Janssen Pharmaceutica NV, dedicated to bringing the investigational protease inhibitor TMC435 to hepatitis C patients in the EMEA region.

Approximately 130-210 million people are infected with hepatitis C worldwide,1 with three to four million people newly infected each year.2 An estimated nine million people are infected with the disease in the WHO European Region.3 Some patients respond better to current hepatitis C treatments than others, depending on factors such as the genotype of the person being treated.2

There is a clear need for continued innovation to confront the burden of disease, reduce treatment time and find a solution for patients that currently do not have effective treatment options.

A commitment to people with hepatitis C

Headquartered in Belgium, Janssen Therapeutics EMEA is committed to the further development and commercialization of its investigational drug TMC435 in the EMEA region.

Jane Griffiths, Janssen EMEA Company Group Chairman, said: “The World Health Organization describes hepatitis C as a ‘viral time bomb’. That is why we have created a dedicated division, which will commercialize 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.”

Global impact

Hepatitis C is an infectious disease affecting primarily the liver, which has a global impact on patients, care givers and society. Hepatitis C can range in severity from a mild illness lasting a few weeks to a serious, lifelong chronic condition that can lead to cirrhosis of the liver, liver cancer and other serious and fatal liver diseases. More than 350,000 people die from hepatitis C-related liver diseases each year worldwide.2

Janssen is committed to its licensing partners with whom it shares the vision of reducing the burden of hepatitis C and making a meaningful impact to eradicate the disease in the future. The creation of Janssen Therapeutics EMEA reinforces Janssen’s commitments to its licensing partners. INCIVO(R), another hepatitis C protease inhibitor from Janssen, will be commercialized separately from TMC435 via Janssen local operating companies.

About Janssen Therapeutics EMEA

Janssen Therapeutics EMEA is on a mission to drive change in the treatment of hepatitis C.

A division of Janssen Pharmaceutica NV, Janssen Therapeutics EMEA is dedicated to bringing the investigational protease inhibitor TMC435 to hepatitis C patients and helping people by increasing their treatment options.

Headquartered in Beerse (Belgium), Janssen Therapeutics EMEA brings together experts from all over the EMEA region to think differently and work tirelessly to help eliminate this devastating disease.

More information can be found at emea.janssentherapeutics.com [http://www.emea.janssentherapeutics.com ]

About TMC435

TMC435 is a once daily potent investigational hepatitis C protease inhibitor in late phase III clinical development being jointly developed by Janssen Pharmaceuticals and Medivir AB to treat chronic hepatitis C virus infections.

TMC435 is being investigated in combination with PegIFN/RBV but is also being evaluated with Direct-acting Antiviral (DAA) agents in interferon-free combinations both with and without ribavirin (RBV).


1. European Association for the Study of the Liver (EASL). Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol 2011; 55: 245-64

2. Hepatitis C, WHO Factsheet, June 2011 http://www.who.int/mediacentre/factsheets/fs164/en/index.html Accessed 11.04.12

3. Hepatitis C, WHO Europe. http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/hepatitis Accessed 11.04.12

(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceutica NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov ,http://www.jnj.com or on request from Johnson & Johnson. Neither Janssen PharmaceuticaNV nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

Source: Janssen

For further information or to interview a spokesperson on the launch of Janssen Therapeutics EMEA, please contact: Hans Vanavermaete, Janssen Therapeutics EMEA, Tel: +32478447278, Email: hvanaver@its.jnj.com; Suzanne Walsh, Publicis Life Brands Resolute, Tel: +44-207-357-8187, Email: suzanne.walsh@publicislifebrandsresolute.com

Source: Janssen Reference – Press Release – 19 April 2012