Tibotec Pharmaceuticals Ltd.

PREZISTA(R) (darunavir) Receives Expanded Marketing Authorisation in the European Union for Treatment-Experienced Adults With HIV-1

    Cork, Ireland (ots/PRNewswire) -

    - For Medical Media Only

    - PREZISTA now Indicated for the Broad Range of Treatment-Experienced Patients in the 27 EU Member States

    Tibotec Pharmaceuticals announced today that the European Commission adopted the decision to broaden the indication for PREZISTA(R) (darunavir), a protease inhibitor, in combination with ritonavir and other antiretroviral medicinal products to the treatment of HIV-1 infection in all treatment-experienced adult patients. Darunavir was developed by Tibotec Pharmaceuticals, Cork, Ireland. Tibotec, a division of Janssen-Cilag, is the organisation responsible for marketing the brand in Europe.

    "The availability of darunavir for the full spectrum of treatment-experienced patients in the European Union (EU) provides caregivers and patients with important additional options to manage HIV," said Roger Pomerantz, M.D., President of Tibotec Research and Development. "Our scientists and development teams are deservingly proud of the difference they make in helping to address the unmet needs of people living with HIV. We will continue our commitment to developing innovative treatment options to help fight HIV and other infectious diseases."

    This Commission decision signifies that the treatment is authorised for use in the European Union, valid in all 27 EU member states. In 2007, a conditional marketing authorisation was granted to darunavir, taken in combination with ritonavir and other antiretroviral medicinal products. This earlier conditional approval limited the use of darunavir to the treatment of highly pre-treated adult patients who failed on more than one regimen containing a protease inhibitor. The full marketing authorisation from the European Commission is expected by the end of December 2008.

    Following today's decision, darunavir, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients, including those that have been highly pre-treated.

    The extended indication was based on the 48-week analysis of the phase 3 TITAN trial in treatment-experienced lopinavir/r-naïve patients. Forty-eight week results from TITAN in lopinavir/r-naïve, treatment-experienced adults:

@@start.t1@@      - Seventy-seven percent of patients in the darunavir/r arm (n=298) vs. 67
         percent of patients in the lopinavir/r arm (n=297) reached less than
         400 copies/mL, (study demonstrated non-inferiority, p<0.0001).@@end@@

    Detailed conditions for the use of this product are described in the updated Summary of Product Characteristics (SmPC), and will be published in the revised European Public Assessment Report (EPAR) which will be available in all official European Union languages.

    Important Safety Information

    In the registrational studies, darunavir was generally well tolerated versus the investigator selected PIs. The majority of the adverse reactions reported in patients who initiated therapy with darunavir 600 mg co-administered with 100 mg ritonavir twice daily were mild to moderate in severity. Thirty percent of the patients experienced at least one adverse drug reaction (at least grade 2 in severity and considered by the investigator at least possibly related to darunavir co-administered with 100 mg ritonavir). The most frequently (greater than or equal to 2 percent) of  those reported adverse reactions were diarrhoea (3.9 percent), hypertriglyceridaemia (3.8 percent), rash (2.8 percent), nausea (2.6 percent), hypercholesterolaemia (2.5 percent) and headache (2.0 percent). 2.6  percent of the patients discontinued treatment due to adverse reactions.

    Before taking darunavir, patients should tell their doctor if they have any medical conditions, including liver problems, including hepatitis B or C, diabetes, symptoms of infections, change in body fat, haemophilia, musculoskeletal problems, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant, or are nursing.

    Darunavir should not be used in patients allergic (hypersensitive) to darunavir or ritonavir or with severe liver problems.

    There are some relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications. 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.

    Darunavir does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

    Please see full Summary of Product Characteristics or visit http://www.emea.europa.eu for more details

    About Tibotec Pharmaceuticals

    Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company, with offices in Yardley, PA, USA and main research and development operations/labs in Mechelen, 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, a division of Janssen-Cilag

    Tibotec, a division of Janssen-Cilag, brings innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa focusing on patients' and healthcare providers' specific needs in this disease domain. The company will also commercialise medicines to combat other viral diseases in the future.

    About 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.

    (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 http://www.sec.gov, http://www.jnj.com 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.)

    Tibotec is a member of the Johnson & Johnson family of companies.

ots Originaltext: Tibotec Pharmaceuticals Ltd.
Im Internet recherchierbar: http://www.presseportal.ch

Contacts: Hans Vanavermaete: +32(0)15-461-017 (office),
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