Actualizado 06/07/2007 03:03
- Comunicado -

New Prezista(R) Phase 3 Study Meets Primary Objective of Non-Inferiority and Secondary Objective of Superiority in Virol

People who are allergic to darunavir or any of its ingredients, or ritonavir should not take darunavir. Before taking darunavir, patients should tell their doctor if they have any medical conditions, including diabetes, liver problems, haemophilia, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant, or are breastfeeding. Darunavir should not be used in patients with severe liver problems.

There were some relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications and lipid lowering agents. Patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Please see full Prescribing Information for more details.

About Darunavir

Darunavir was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the European Union and other countries by Tibotec, a division of Janssen-Cilag. In the U.S., darunavir is marketed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. In Canada, darunavir is marketed by Tibotec, a division of Janssen-Ortho Inc.

About Tibotec Pharmaceuticals Ltd.

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

Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program for darunavir includes access pricing, registration, medical education for appropriate use and voluntary licensing.

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 health care providers' specific needs in this disease domain. The company will also commercialise medicine to combat other viral diseases in the future.

Janssen-Cilag

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

    
    Contact: Hans Vanavermaete
             Mobile: +32-(0)-478-447-278
             Office: +32-(0)-15-461-017
    (i) The TITAN Study included mild, moderate and highly
        treatment-experienced patients, which is outside the current licensed
        indication for PREZISTA in highly treatment-experienced patients.

Hans Vanavermaete, Mobile, +32-(0)-478-447-278, or Office, +32-(0)-15-461-017, for Tibotec

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