Index Of Current Hepatitis C Drugs In Development
Vertex ALS-2200 (VX-135)
Bristol-Myers Squibb Daclatasvir, also known as BMS-790052
EASL- Bristol-Myers oral hepatitis C regimen daclatasvir/asunaprevir/BMS-791325
April 5 2013
Vertex Enters Agreement with Bristol-Myers Squibb for Phase 2 All-Oral Studies of VX-135 in Combination with Daclatasvir for the Treatment of Hepatitis C
-Two Phase 2 studies to evaluate once-daily combination of Vertex's investigational nucleotide analogue VX-135 and BMS' investigational NS5A replication complex inhibitor daclatasvir-
-Study in people with genotype 1 hepatitis C planned to begin in second quarter of 2013-
-Study in people with genotypes 1, 2 and 3 hepatitis C, including people with cirrhosis, planned for second half of 2013-
WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb Company (NYSE: BMY) to conduct Phase 2 studies of once-daily all-oral
treatment regimens containing Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C.
As part of the agreement, Vertex plans to conduct two Phase 2 studies of the combination, including an initial study in treatment-naïve people with genotype 1 HCV infection planned for the second quarter of 2013. Vertex plans to begin a subsequent study in treatment-naïve people infected with genotype 1, 2 or 3 HCV, including those with cirrhosis, in the second half of 2013, pending data from the initial study.
"With more than 170 million people infected worldwide, there is a critical need for new hepatitis C medicines that can offer
people simpler and more tolerable treatment regimens that provide high cure rates," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex.
"These studies with daclatasvir will provide the first opportunity to evaluate VX-135 as part of all-oral regimens in people with multiple hepatitis C genotypes and in people with cirrhosis."
Clinical Development Plans for VX-135 with Daclatasvir
Under the terms of the agreement, Vertex will conduct two Phase 2 studies of VX-135 in combination with
The first study will enroll approximately 20 non-cirrhotic,treatment-naïve people with chronic genotype 1 HCV infection and is expected to begin in the second quarter of 2013. In the second half of 2013, Vertex plans to conduct a subsequent study in approximately 250 treatment-naïve people with chronic genotype 1, 2 or 3 HCV infection, including those with cirrhosis. Each of these studies is expected to evaluate safety, tolerability, pharmacokinetics and viral cure rates (SVR4 and SVR12) of multiple all-oral regimens of VX-135 and daclatasvir dosed once daily, pending regulatory discussions. Vertex will also conduct co-formulation activities to evaluate the potential for development of a once-daily fixed-dose combination regimen. Further clinical development activities beyond the Phase 2 studies are not covered as part of this agreement.
VX-135 is a uridine nucleotide analogue pro-drug designed to inhibit the replication of the hepatitis C virus by acting on the
NS5B polymerase. In people with genotype 1, treatment with a 200mg once-daily dose of VX-135 in a 7-day viral kinetic study was well-tolerated, with no discontinuations due to adverse events, and resulted in a 4.54 log10 median
reduction from baseline in HCV RNA. Data from a 7-day viral kinetic study of VX-135 in people with genotypes 2, 3 and 4 were consistent with data observed in people with genotype 1 and have been submitted for presentation at a future
Vertex gained worldwide rights to ALS-2200, known as VX-135 in Phase 2 studies, through an exclusive licensing agreement signed with Alios BioPharma, Inc. in June 2011. The agreement also includes a research program that focuses on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional
compounds for development emerging from the research program.
Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential DAA-based hepatitis C treatment regimens. Studied in more than 4,100 patients to date, daclatasvir is in Phase 3 development.
Daclatasvir is part of a portfolio of investigational compounds with different mechanisms of action that Bristol-Myers
Squibb is developing for the treatment of hepatitis C. These compounds are being studied as part of multiple novel treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies.
About Hepatitis C
Hepatitis C is a serious liver infection caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience
symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1 Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 If treatment is not successful and a person does not achieve a viral
cure, they remain at an increased risk for progressive liver disease.3,4
More than 170 million people worldwide are chronically infected with hepatitis C.5 In the United States, up to 5 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.6,7 Hepatitis C is four times more prevalent in the United States compared to HIV.7 The majority of people with hepatitis C in the United States were born between
1945 and 1965, accounting for three fourths of people with the infection.8 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 15,000 deaths annually.9,10 By 2029, total
annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies
so people with serious diseases can lead better lives.
and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in
the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and for three years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences.
Vertex Special Note Regarding
1 Centers for Disease Control and
Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf
Updated June 2010. Accessed September 21, 2012.
2 Pearlman BL and Traub
N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C
Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011
3 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K,
Lok AS. Outcome of sustained virological responders and non-responders in the
Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial.
Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
4 Veldt BJ, Heathcote
J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients
with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine.
2007; 147: 677-684.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB.
Diagnosis, management and treatment of hepatitis C; An update. Hepatology.
6 Chak, E, et. al. Hepatitis C Virus Infection In USA:
An Estimate of True Prevalence. Liver Intl. 2011;1096 -1098.
of Medicine of the National Academies. Hepatitis and liver cancer: a national
strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell
Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx
Updated January 11, 2010. Accessed September 21, 2012.
8 Centers for
Disease Control and Prevention. Recommendations for the Identification of
Chronic Hepatitis C Virus Infection Among Persons Born During 1945—1965.
Morbidity and Mortality Weekly Report. August 17, 2012; 61(RR04);1-18.
Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy
for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
10 Ly KN, et al. The Increasing Burden of Mortality From Viral Hepatitis
in the United States Between 1999 and 2007. Ann Intern Med. 2012;156:271-278.
11 Pyenson B, Fitch K, and Iwasaki K. Consequences of Hepatitis C Virus
(HCV): Costs of a Baby Boomer Epidemic of Liver Disease. Milliman, Inc. May
2009. Available at: http://www.vrtx.com/assets/pdfs/MillimanReport.pdf
VRTX — GEN
Vertex Pharmaceuticals IncorporatedMedia:
Zach Barber, 617-341-6470
Kelly Lewis, 617-961-7530
Source: Vertex Pharmaceuticals Incorporated
Vertex Signs Deal With Bristol-Myers for Hepatitis C Treatment Studies
Vertex Pharmaceuticals Inc. (VRTX) entered a nonexclusive agreement with Bristol-Myers Squibb Co. (BMY) to conduct midstage studies for hepatitis C treatments, its latest collaboration as part of its push to develop
treatments for the liver disease.
The Phase 2 studies are for once-daily all-oral treatment regimens containing Vertex's nucleotide analogue hepatitis C
virus polymerase inhibitor VX-135 and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir.
As part of the agreement, Vertex plans to conduct two Phase 2 studies of the combination, including an initial study in
treatment-naive people with genotype 1 hepatitis C virus, planned for the second quarter.
Vertex plans to begin a subsequent study in treatment-naive people infected with genotype 1, 2 or 3 hepatitis C virus, including those with cirrhosis, in the second half, pending data from the initial study.
"With more than 170 million people infected worldwide, there is a critical need for new hepatitis C medicines that can offer people simpler and more tolerable treatment regimens that provide high cure rates," Vertex Chief Medical Officer
Robert Kauffman said. "These studies with daclatasvir will provide the first opportunity to evaluate VX-135 as part of all-oral regimens in people with multiple hepatitis C genotypes and in people with cirrhosis."
Treatments for hepatitis C are considered lucrative because the disease is prevalent in large sections of the global population. The virus, which can be transmitted sexually or through use of shared needles and at tattoo parlors, affects some
170 million people world-wide.
Both Vertex and Bristol-Myers have grappled with setbacks in their push to develop treatments for hepatitis C. In
August, Bristol-Myers said it had suspended its study of a drug intended to treat hepatitis C after a patient suffered heart failure, which the company called a "serious safety issue."
Meanwhile in December, the Food and Drug Administration placed a new label on Vertex's hepatitis C drug Incivek, warning
patients that the drug has caused fatal skin rashes in some patients.
The latest collaboration comes after Vertex in November teamed up with two rivals to study potential new treatments for hepatitis C. In separate partnerships, Vertex said it would begin mid-stage trials in 2013 to study its investigational drug
VX-135 in combination with treatments being developed by GlaxoSmithKline PLC (GSK) and Johnson & Johnson's (JNJ) Janssen Pharmaceuticals unit.
Shares of Vertex closed Thursday at $52.95, while those of Bristol-Myers closed at $40.78. Both stocks were inactive
Write to Saabira Chaudhuri at email@example.com
Subscribe to WSJ:
Copyright © 2013 Dow Jones Newswires