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Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds

- Not Intended for Journalists in the UK or Ireland - New Findings From ARTEMIS and TITAN Studies Demonstrate Growth of the

Tibotec Virology Franchise

GLASGOW, Scotland, Nov. 12 /PRNewswire/ -- New data on PREZISTA(R) (darunavir), a protease inhibitor from Tibotec, will be presented at the Ninth International Congress on Drug Therapy in HIV Infection (HIV9) in Glasgow, U.K., from 09-13 November 2008. The company also presented new data on PREZISTA(R) at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C., from 25-28 October 2008. These presentations follow key regulatory approvals and decisions for PREZISTA(R) and INTELENCE(TM) (etravirine), a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI). The company continues to research various compounds in hepatitis C, tuberculosis and HIV.

"The Tibotec data being presented at HIV9 culminate an exciting three months for the company and for the entire HIV community," said Roger Pomerantz, President, Tibotec Research & Development. "The data we've amassed and the regulatory milestones we've achieved this year are signs of our dedication to finding innovative ways to meet the needs of people with HIV."

Recent Regulatory Milestones for Tibotec in HIV

- 28 August 2008 - The European Commission approved etravirine, in

combination with a boosted protease inhibitor and other antiretroviral

medicinal products, for the treatment of human immunodeficiency virus

type 1 (HIV-1) infection in antiretroviral treatment-experienced adult


- 21 October 2008 - The U.S. FDA granted traditional approval to

darunavir, coadministered with low dose ritonavir, for twice-daily use

in treatment-experienced adult patients, as well as an expanded

indication for once-daily dosing as part of HIV combination therapy in

treatment-naive adults (those who have never taken HIV medication


- 23 October 2008 - Darunavir received a positive opinion from the

European Medicines Agency's (EMEA) Committee for Medicinal Products for

Human Use (CHMP) to extend the drug's indication to treat human

immunodeficiency virus (HIV-1) infection to include

treatment-experienced adult patients. Darunavir, coadministered with low

dose ritonavir, is currently indicated for the treatment of HIV-1 in

combination with other antiretroviral medicines in highly pre-treated

adult patients who failed more than one regimen containing a protease


Tibotec Data at ICAAC and HIV9 Data from multiple studies examining the use of darunavir in patients with varying levels of treatment experience were presented at ICAAC and will be presented at HIV9. Highlights include:

- A new analysis of ARTEMIS (AntiRetroviral Therapy with TMC114 Examined

In Naive Subjects), a randomised, controlled, open-label Phase III trial

that compares the 96-week efficacy and safety of darunavir/ritonavir

with lopinavir/ritonavir in treatment-naive adults. ARTEMIS is the first

study to examine darunavir/ritonavir in a once-daily dose in

treatment-naive patients with HIV. These data were presented at ICAAC on

26 October.

- A new analysis of TITAN (TMC114/r In Treatment-experienced patients

Naive to lopinavir), a randomised, controlled, open-label Phase III

study that compares the 96-week efficacy and safety of

darunavir/ritonavir with lopinavir/ritonavir in treatment-experienced,

lopinavir-naive patients. These data will be presented at HIV9 on 13


The ARTEMIS and TITAN studies are ongoing. Darunavir and etravirine were developed by Tibotec Pharmaceuticals, Cork, Ireland. Tibotec, a division of Janssen-Cilag, is responsible for marketing the brand in Europe.

Please see full Prescribing Information for more details.

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company, with offices in Yardley, PA and main research and development operations/labs in Belgium. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.

About Tibotec

Tibotec, a division of Janssen-Cilag, will bring innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa This new division was created within the Janssen-Cilag companies in October 2005 to focus on patients' and healthcare providers' specific needs in this disease domain. The company will also commercialise medicine to combat other viral diseases in the future.


Janssen-Cilag is a leader in traditional and biological medicines for disorders such as gastroenterology, women's health, mental health and neurology as well as for pain, oncology, haematology and nephrology.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory

approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. 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 December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at, or on request from Johnson & Johnson.

The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

Contact: Hans Vanavermaete

Mobile: +32(0)478-447-278

Office: +32(0)15-461-017

SOURCE Tibotec Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

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