Vertex Pharmaceuticals to Present Data at EASL Suggesting Telaprevir's Potential for Use in a Broad Range of HCV Patients and Highlighting the Company's Expanded STAT-C Portfolio
-PROVE 3 results to be presented at late breaker session on Saturday, April 25, 2009-
-Interim data from two Phase 2 studies of telaprevir indicate activity across multiple genotypes in treatment-naïve HCV patients-
-Early data from newly-acquired polymerase inhibitors suggest rapid, powerful antiviral activity with favorable safety and tolerability profile-
COPENHAGEN--(BUSINESS WIRE)--Apr 21, 2009 - New clinical data being presented at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark will highlight recent observations of the hepatitis C virus (HCV) protease inhibitor telaprevir in the treatment of multiple HCV genotypes, and the early safety and antiviral profile of the HCV polymerase inhibitor VCH-222. In addition, sustained viral response (SVR) rates from the PROVE 3 clinical trial of telaprevir in patients who failed prior HCV therapy will be reviewed at a late breaker oral presentation on Saturday, April 25, 2009. These data will be the subject of a separate announcement in accordance with EASL publication rules. Telaprevir is one of the most advanced of a new class of specifically targeted antiviral therapies for hepatitis C (STAT-C), and is being developed by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) in collaboration with Tibotec and Mitsubishi Tanabe Pharma. Vertex recently acquired VCH-222 along with other early-stage compounds as part of its acquisition of ViroChem Pharma Inc.
“Results for telaprevir continue to show strong outcomes across a broad population of HCV patients, including unprecedented data for the most difficult-to-treat populations to be presented at EASL, and the potential to shorten the treatment duration in treatment-naïve patients, with a developing safety profile consistent with what we have reported earlier,” said Freda Lewis-Hall, M.D., Executive Vice President, Medicines Development and Chief Medical Officer of Vertex. “In addition, HCV polymerase inhibitors that were recently added to Vertex's portfolio showed substantial antiviral activity in early testing when used as single agents. We believe they have the potential for clinical development in combination with telaprevir.”
“Telaprevir is the only agent that has shown the possibility of achieving SVR rates in combination therapy approaching 70% in the treatment-naïve setting with a significantly shortened treatment duration when compared with current therapy, while our recently acquired polymerase compounds are showing strong early antiviral data, which may put us in a good position to shape new STAT-C combinations with telaprevir,” said Kurt Graves, Executive Vice President, Chief Commercial Officer and Head, Strategic Development of Vertex.
Interim data from two Phase 2 studies (C209 and C210) in treatment-naïve HCV patients show substantial antiviral activity against HCV genotypes 2 and 4 when telaprevir is combined with the standard of care compared with standard of care alone. Across both studies, HCV genotype 2, 3 and 4 patients were randomized into one of three arms to receive 15 days of telaprevir alone, telaprevir in combination with pegylated interferon (peg-IFN) and ribavirin (RBV), or peg-IFN and RBV alone. A 5.3, 4.7 and 3.4 log10 IU/mL mean plasma HCV RNA reduction was achieved after 15 days of telaprevir, peg-IFN and RBV treatment as compared to a 4.0, 4.5 and 2.0 log10 IU/mL mean plasma HCV RNA reduction in the control peg-IFN plus RBV arms in HCV genotype 2, 3 and 4 patients, respectively.
The first human data in treatment-naïve genotype 1 HCV patients with the polymerase inhibitor VCH-222 showed it to be well-tolerated up to 1,500mg administered as a single dose in healthy volunteers and at 750mg twice daily for three days in HCV-infected patients. VCH-222 was evaluated in a Phase 1, randomized double-blind ascending, single dose trial. In this study, VCH-222 dosed as 750mg twice daily resulted in a median plasma HCV RNA reduction of 3.7 log10 IU/mL at the end of a three-day treatment regimen in five patients. The results were similar from patient to patient, including for the single HCV genotype 1b patient included in this study, and represent the most substantial reduction in viral load reported to date with an investigational HCV polymerase inhibitor dosed as a single agent. No serious adverse events were observed in the study. Additional preclinical studies addressing the identification and characterization of VCH-222 and its pharmacokinetic profile are also being presented at EASL.
Vertex Data Presentations at EASL Meeting
Telaprevir Late Breaker Presentation:
1. Telaprevir in Hepatitis C Genotype-1-Infected Patients with Prior Non-Response, Viral Breakthrough or Relapse to Peginterferon-alfa-2a/b and Ribavirin Therapy: SVR Results of the PROVE 3 Study; April 25, 2009, 5:00 - 5:15 p.m. CET (11:00 - 11:15 a.m. ET), Oral Presentation by Michael Manns, M.D. Principal Investigator for the PROVE 3 study and Director of the Department of Gastroenterology, Hepatology and Endocrinology at Medical School of Hannover, Germany
Other Telaprevir Presentations:
2. Results of a Proof of Concept Study (C210) of Telaprevir Monotherapy and in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-Naïve Genotype 4 HCV Patients; April 23, 2009, 5:45 - 6:00 p.m. CET, Oral Presentation
3. Activity of Telaprevir Alone or in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Genotype 2 and 3 Hepatitis-C Patients: Interim Results of Study C209; April 24, 2009, 11:45 a.m. - 12:00 p.m. CET, Oral Presentation
1. Safety, Tolerability and Pharmacokinetics of the HCV Polymerase Inhibitor VCH-222 Following Single Dose Administration in Healthy Volunteers and Antiviral Activity in HCV-Infected Individuals; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
2. Identification and characterization of VCH-222, A Novel Potent and Selective Non-Nucleoside HCV Polymerase Inhibitor; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
3. Preclinical Pharmacokinetic and ADME Characterization of VCH-222, A Novel Non-Nucleoside HCV NS5B Polymerase Inhibitor; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
Other EASL Presentations:
Two abstracts related to VCH-916, an additional polymerase inhibitor that Vertex obtained as part of its acquisition of ViroChem Pharma in March 2009, will also be presented at EASL and are listed below:
Safety, Tolerability and Antiviral Activity of VCH-916, A Novel Non-Nucleoside HCV Polymerase Inhibitor in Patients with Chronic HCV Genotype-1 Infection; April 24, 2009, 5:45 - 6:00 p.m. CET, Oral Presentation
Genotypic and Phenotypic Analysis of HCV NS5B Variants Selected From Patients Treated with VCH-916; April 25, 2009, 8:00 a.m. - 6:00 p.m. CET, Poster Presentation
Webcast from EASL at 7:00 p.m. CET (1:00 p.m. ET) on Saturday, April 25
Vertex intends to provide a live webcast of its investor presentation from Copenhagen beginning at 7:00 p.m. CET (1:00 p.m. ET) on Saturday, April 25, 2009. The presentation may be accessed from the 'Events and Presentations' link on the home page of Vertex's website at www.vrtx.com. A replay of the webcast will also be available on the Company's website until May 9, 2009. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease. HCV, a serious public health concern affecting 3.4 million individuals in the United States, is spread through direct contact with the blood of infected people. Though many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Chronic HCV significantly increases a person's risk for developing long-term infection, chronic liver disease, cirrhosis or death. The burden of liver disease associated with HCV infection is increasing, and current therapies typically provide sustained benefit in less than half of patients with genotype 1 HCV, the most common strain of the virus. As many as 250,000 patients in the United States have received at least one course of treatment with pegylated interferon and ribavirin but have not achieved sustained virologic response. Patients who have failed interferon-based treatment typically have few or no available treatment options, and are at risk for progressive liver disease. In a recent study, the risk of liver failure, cancer or death following unsuccessful HCV treatment was 23% after 4 years, and 43% after 8 years (1).
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 commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
(1) Veldt et al, "Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis," Annals of Internal Medicine, 20 November 2007; 147: 677-684.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements regarding (i) telaprevir's potential for use in a broad range of HCV patients and data highlighting Vertex's expanded STAT-C portfolio, (ii) interim data from two Phase 2 studies indicating activity across multiple genotypes in treatment-naïve patients, (iii) early data from newly acquired polymerase inhibitors suggesting rapid, powerful antiviral activity with a favorable safety and tolerability profile, (iv) the early safety and antiviral profile of the HCV polymerase inhibitor VCH-222, (v) presentations regarding data on telaprevir and VCH-222 that are expected to be made at EASL, (vi) the potential to shorten the HCV treatment duration with telaprevir, and (vii) the potential for clinical development of the Company's polymerase inhibitors in combination with telaprevir and the Company's potential ability to shape new STAT-C combinations. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the outcomes for each of its clinical trials of telaprevir (including the ongoing Phase 3 clinical trials of telaprevir) may not be favorable, that there may be varying interpretations of data produced by one or more of our clinical trials, that regulatory authorities will require more extensive data for a telaprevir NDA filing than currently expected, that future competitive or other market factors may adversely affect the commercial potential for the Company's product candidates in HCV and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at www.vrtx.com. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
Contact: Vertex Pharmaceuticals Incorporated
Jane A. Kramer, 617-444-6924
Zachry Barber, 617-444-6470
Michael Partridge, 617-444-6108 (office) or 617-767-6108 (at EASL)
Lora Pike, 617-444-6755 (office) or 857-413-0947 (at EASL)
Posted: April 2009