Tibotec Pharmaceuticals Ltd.

Drug-Drug Interactions Clinically Manageable With PREZISTA(TM)

Glasgow, Scotland, November 14 (ots/PRNewswire) - - Data Presented at HIV 8 Conference - New studies on the use of PREZISTA(TM), an investigational anti-HIV medication, suggest that it can be co-administered with many common medications taken by people with HIV, including other antiretrovirals, proton pump inhibitors, H2 blockers and selective serotonin reuptake inhibitors. According to current HIV treatment guidelines, potential drug interactions between HIV antiretrovirals and other necessary drugs can be dangerous and require special monitoring(i). Three studies, including one oral poster, on the co-administration of PREZISTA, were presented at the Eighth Annual International Congress on Drug Therapy in HIV Infection (HIV 8) taking place in Glasgow, Scotland from 12 - 16 November. PREZISTA (darunavir, also known by the investigational compound number TMC114), co-administered with 100 mg ritonavir (darunavir/rtv), is being studied for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients. It is currently approved in the United States, Canada and Russia. An application for marketing authorization was filed with the European Agency for the Evaluation of Medicinal Products in January 2006. "With many HIV-infected people taking multiple medications, the increased potential for drug interactions poses a serious challenge in finding a safe and effective antiretroviral treatment regimen," said David J. Back, Ph.D., Professor, Department of Pharmacology, University of Liverpool. "These data are important because they provide information on the interactions between PREZISTA/rtv and other medications commonly used in patients with HIV." Use of PREZISTA with common medications (Oral poster PL 5.1) Location and time: Clyde Auditorium; Tuesday, November 14, 10:30 - 10:45 a.m. GMT Dr. Back reported results in an oral presentation from clinical studies evaluating the pharmacokinetic interactions between darunavir/rtv and a variety of drugs including antiretrovirals such as atazanavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, efavirenz, nevirapine, tenofovir disoproxil fumarate; antibiotics such as clarithromycin and ketoconazole; and other medications for various conditions including atorvastatin, omeprazole, ranitidine, sildenafil, sertraline, paroxetine and oral contraceptives. Results showed that darunavir/rtv may be combined with many drugs with no dose adjustments. Some co-administered drugs, such as indinavir, sildenafil and atorvastatin may require dose adjustments. In general, the study found that drug interactions between darunavir/rtv and drugs commonly used in patients with HIV are manageable. Pharmacokinetic interaction between PREZISTA with SSRIs assessed (Poster # P295) Location and time: Exhibition Hall 4; Monday, November 13 to Wednesday, November 15, 10:00 a.m. - 7:00 p.m. GMT The pharmacokinetic interaction between darunavir/rtv and the selective serotonin reuptake inhibitors (SSRIs), paroxetine and sertraline, were assessed in a phase I, open-label, two-panel, randomised, crossover study in 36 HIV-negative, healthy volunteers presented by Vanitha Sekar, Ph.D. of Tibotec Pharmaceuticals. Safety and tolerability also were assessed. The study found that the pharmacokinetics of darunavir/rtv were not significantly affected in the presence of sertraline or paroxetine, and that darunavir/rtv was generally well tolerated. Paroxetine and sertraline total concentrations were decreased in the presence of darunavir/rtv. Clinical monitoring is recommended when co-administering darunavir/rtv with SSRIs, although studies have not shown a correlation between plasma concentration of SSRIs and antidepressant response. Co-administration of PREZISTA with methadone (Poster # P294) Location and time: Exhibition Hall 4; Monday, November 13 to Wednesday, November 15, 10:00 a.m. - 7:00 p.m. GMT Dr. Sekar also conducted a trial assessing the effect of multiple doses of darunavir/rtv on plasma concentrations of methadone since administration of boosted protease inhibitors has been shown to decrease methadone plasma concentrations. Results of the open-label, add-on trial involving 16 patients found co-administration of the treatment with methadone did not adversely affect the blood plasma concentrations of methadone, methadone adjustment was not required when administered with darunavir/rtv, and withdrawal syndrome was uncommon, occurring in one patient (1/16 patients, 6 percent) during the co-administration period. About PREZISTA PREZISTA (darunavir) is an investigational protease inhibitor that is currently in Phase III comparative clinical trials versus lopinavir/ritonavir in treatment-naïve (ARTEMIS) and treatment-experienced patients (TITAN). PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others. In studies, darunavir/rtv was generally well tolerated. The most common moderate to severe side effects associated with darunavir include headache (3.8 percent), diarrhoea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent). Mild to moderate rash was seen in 7 percent of patients. Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. Four percent of patients discontinued treatment due to adverse events. People who are allergic to darunavir or any of its ingredients or ritonavir (Norvir) should not take darunavir. It should be used with caution in patients with known sulfonamide allergy. There were few relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications, proton pump inhibitors, and H2 receptor antagonists. Patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Due to the need for co-administration of darunavir with 100mg ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. Before taking darunavir, patients should tell their healthcare provider 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 nursing. Darunavir should be used with caution in patients with hepatic impairment. High blood sugar, diabetes or worsening of diabetes, muscle pain, tenderness or weakness, and increased bleeding in people with haemophilia have been reported in patients taking protease inhibitor medicines like darunavir. Changes in body fat have been seen in some patients taking anti-HIV medicines, including loss of fat from legs, arms and face, increased fat in the abdomen and other internal organs, breast enlargement and fatty lumps on the back of the neck. The cause and long-term health effects of these conditions are not known at this time. Clinical laboratory safety observed in the darunavir group was comparable to the control group. PREZISTA was developed by Tibotec Pharmaceuticals Ltd. In the U.S., it is marketed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. In Canada, it is marketed by Tibotec, a division of Janssen-Ortho Inc. Pending regulatory approval, Tibotec, a division of Janssen-Cilag, will commercialise PREZISTA in Europe and other countries. For further information, please visit www.tibotec.com. 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 PREZISTA 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 against 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. (i) "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents," DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents - A Working Group of the Office of AIDS Research Advisory Council (OARAC); Accessed at: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf; last updated October 10, 2006. Web site: http://www.tibotec.com ots Originaltext: Tibotec Pharmaceuticals Ltd. Im Internet recherchierbar: http://www.presseportal.ch Contact: Kellie McLaughlin, mobile: +1-609-466-3808; or Hans Vanavermaete, mobile: +32-478-447-278

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