Data On Investigational Compounds Being Co-Developed By Tibotec For The Treatment Of Chronic Hepatitis C Presented At EASL 2008

Main Category: Liver Disease / Hepatitis
Article Date: 25 Apr 2008 - 3:00 PDT

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Tibotec BVBA, a global pharmaceutical company dedicated to the discovery and development of innovative drugs that fight infectious diseases, is now building a portfolio of novel antiviral therapies to treat hepatitis C virus (HCV). The investigational protease inhibitors (PI), telaprevir (VX-950) and TMC435350, are being co-developed by Tibotec with Vertex and Medivir, respectively. Data on these compounds will be presented at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in Milan, Italy.

According to the World Health Organization, an estimated 170 million persons globally are chronically infected with HCV and three to four million persons are newly infected each year.[i] Chronic infection with HCV, a viral infection of the liver, can lead to cirrhosis and liver cancer, and is the most common cause of liver transplant in Europe.[ii],[iii] The current standard of care for HCV patients, treatment with pegylated interferon combined with ribavirin, is effective in thirty to fifty percent of patients with genotype-1 HCV, the most common type globally.[iv] However, treatment with this regimen can cause significant side effects and no effective treatment regimen has been identified for those patients that have failed treatment, sometimes known as non-responders.[v],[vi] The development of new therapies, particularly direct antivirals with different modes of action, will allow HCV patients to undergo a more effective treatment regimen.[vii],[viii]

"Our goal is to develop and bring to market new direct antivirals for the treatment of hepatitis C that have significant advantages over the existing standard of care," said Roger Pomerantz, MD, President of Tibotec Research and Development.

As a global virology leader committed to patient care, Tibotec uses innovative science and expertise and works with partners to research, develop, manufacture, and market drugs of unmet need. To date, Tibotec has brought to market PREZISTATM (darunavir), an antiretroviral medication for treatment-experienced patients with HIV, and has submitted a marketing application for its second HIV medication, INTELENCETM (etravirine), to the European Agency for the Evaluation of Medicinal Products (EMEA). Its promising pipeline comprises potential treatments for infectious diseases including HIV, tuberculosis, and HCV.

Telaprevir: Key Presentations at EASL

Data from four abstracts on telaprevir, which is in phase III development, will be presented in poster and oral presentations at EASL. Highlights include early results from VX06-950-107, an ongoing, open-label study to evaluate the antiviral response to treatment with telaprevir, combined with pegylated interferon alfa-2a (Peg-IFN) and ribavirin (RBV), in patients who have failed treatment with Peg-IFN/RBV in any of the three PROVE trials will be presented as a late-breaker poster. An interim analysis examined a small subset of patients that included non-responders and relapsers. These are the first data to be presented on the use of telaprevir in patients who have previously failed previous Peg-IFN/RBV therapy.

Further results from PROVE-1 (U.S.) and PROVE-2 (Europe), two randomised, placebo-controlled Phase II studies of telaprevir combined with Peg-IFN and with or without RBV in treatment-naïve patients with HCV genotype 1, will be presented in oral sessions on Thursday, 24 April and Friday, 25 April, respectively.

Telaprevir is currently being studied in Phase III clinical trials in treatment-naïve patients; a Phase III clinical trial in patients that have previously failed treatment will begin later this year. Tibotec has the right to develop and commercialise telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand; Vertex will commercialise telaprevir in the U.S., Canada and Mexico.

TMC435350: First Results in Patients

In addition, data from a placebo controlled, double-blind Phase I study of TMC435350 will be presented in an oral session on Friday, 25 April. This study examined the safety, tolerability and pharmacokinetics of TMC435350 in healthy volunteers and also examined antiviral activity of the drug in a small number of HCV patients who had previously failed treatment. These are the first data to be presented on the use of TMC435350 in hepatitis C patients.

Tibotec and Medivir discovered TMC435350 through a drug discovery collaboration. Tibotec has the right to commercialise the compound throughout the world, excluding the Nordic countries. A Phase IIa proof-of-concept trial is ongoing in Europe and is currently recruiting patients.

About Tibotec

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

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialise its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline. http://www.vpharm.com

About Medivir

Medivir is an innovative, specialist research company that develops drugs with the objective of becoming a sustaining, profitable pharmaceuticals company. Medivir is located in Huddinge, Sweden and at Chesterford Research Park, Essex, UK. Medivir was listed at the Stockholm Exchange in 1996. Medivir's research portfolio includes projects against HIV, jaundice, shingles, cold sores, osteoporosis, RA (rheumatoid arthritis), asthma and MS (multiple sclerosis).http://www.medivir.com

References

[i] World Health Organization (WHO). Revised October 2000. Fact sheet No. 164. .

[ii] World Health Organization (WHO). Revised October 2000. Fact sheet No. 164. .

[iii] Risk factors for hepatitis C recurrence after liver transplantation. J Viral Hepat. 2007 Nov;14 Suppl 1:89-96. Roche B, Samuel D. Assistance Publique-Hopitaux de Paris, Hôpital Paul Brousse, Centre Hépato-Biliaire; and INSERM, Unité 785; and Université Paris-Sud, UMR-S 785, Villejuif, France.

[iv] World Health Organization (WHO). Fact sheet No. 164. Revised October 2000. Fact sheet No. 164. .

[v] Using Pegylated Interferon and Ribavirin to Treat Patients with Chronic Hepatitis C. American Family Physician. 2005 Aug. Volume 72, Number 4. Raymond P. Ward, M.D., PH.D., Marcelo Kugelmas, M.D.

[vi] Relapse to prior therapy is the most important factor for the retreatment response in patients with chronic hepatitis C virus infection. Liver International. 2007 Sep;27(7):954-9. Sagir A, Heintges T, Akyazi Z, Oette M, Erhardt A, Häussinger D. Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinik Düsseldorf, Düsseldorf, Germany. sagir@med.uni-duesseldorf.de

[vii] Relapse to prior therapy is the most important factor for the retreatment response in patients with chronic hepatitis C virus infection. Liver Int. 2007 Sep;27(7):954-9. Sagir A, Heintges T, Akyazi Z, Oette M, Erhardt A, Häussinger D. Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinik Düsseldorf, Düsseldorf, Germany. sagir@med.uni-duesseldorf.de

[viii] Antiviral Research. Volume 71, Issues 2-3, September 2006, Pages 363-371. Special Issue To Honour Professor Erik De Clercq

Medivir