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Give me a ‘C’
December 2012
by Kelsey Kaustinen  |  Email the author


CAMBRIDGE, Mass.—Vertex Pharmaceuticals Inc. has announced the establishment of a non-exclusive agreement with GlaxoSmithKline PLC (GSK) to conduct a Phase II proof-of-concept study of an all-oral regimen for treating hepatitis C, consisting of Vertex's nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and GSK's NS5A inhibitor GSK2336805.  
Under the agreement, Vertex and GSK will split the costs associated with the study, and no upfront payments or milestone payments are included. The study is intended to determine the safety, tolerability and viral cure rates of a 12-week combination of VX-135 and GSK2336805.  
The Phase II proof-of-concept study will enroll treatment-naοve people who have chronic non-cirrhotic genotype 1 hepatitis C. Vertex will conduct the study in the United States early next year, pending discussions with regulatory authorities. The study will test multiple 12- week combination regimens of the two compounds, with and without ribavirin, a nucleotide analogue and one of the standards of care in treating hepatitis C. The agreement does not cover further clinical development studies beyond the Phase II study.
"This agreement underscores our broad commitment to develop all-oral treatment regimens for people with hepatitis C using medicines within our own pipeline and by working in collaboration with other companies like GSK who share our commitment to further improve treatment of this disease," Dr. Robert Kauffman, senior vice president and chief medical officer at Vertex, said in a press release. "We are focused on the development of new all-oral treatments for hepatitis C that have the potential to provide a high cure rate with only 12 weeks of treatment, and we look forward to the start of this study with GSK."  
VX-135 is an investigation uridine nucleotide analogue pro- drug designed for inhibition of HCV replication by acting on the NS5B polymerase. The compound has shown to have a high barrier to drug resistance in in-vitro studies, with demonstrated antiviral activity across all genotypes of HCV, including those that are more prevalent outside of the United States. Based on its first seven-day viral kinetic data for the compound, gathered earlier this year, Vertex plans to initiate several all-oral, Phase II proof-of-concept studies, which will including one study of VX-135 and ribavirin as well as one of VX-135 and telaprevir, Vertex's approved protease inhibitor (marketed as INCIVEK for patients with chronic genotype 1 hepatitis C).  
GSK2336805 is an investigational NS5A replication complex inhibitor under development as a potential hepatitis C treatment.  
Zachry Barber, director of corporate communications for Vertex, says this is not the first time the two companies have worked together, citing a 2005 collaboration in which GSK and Vertex collaborated on the development of VX-409 for the treatment of pain, though the compound is no longer in development. The company, he notes, believes that "we are well positioned to conduct multiple all-oral studies in the coming year, and to generate a significant amount of data in 2013 to support advancing into pivotal development in 2014."  
Vertex announced a similar agreement with Janssen Pharmaceuticals Inc. at the same time as the GSK agreement. Under the agreement with Janssen, Vertex and Janssen will conduct a Phase II proof-of-concept study of an all-oral hepatitis C treatment regimen that combines VX-135 and Janssen 's protease inhibitor simeprevir to evaluate safety, tolerability and viral cure rates of a 12-week combination. The companies will share development costs, and no upfront or milestone payments apply.  
Current World Health Organization (WHO) statistics place the number of hepatitis C sufferers at roughly 150 million worldwide, with approximately three million of that number located in the United States, according to the Centers for Disease Control. An estimated 350,000 deaths are attributed to hepatitis C-related liver diseases annually, according to WHO. The Institute of Medicine of the National Academies noted that annual medical costs associated with hepatitis C are expected to total approximately $85 billion in the United States by 2029.  

GSK, Imagine Institute collaborate on rare skin disorder  
PARIS—On Nov. 12, GlaxoSmithKline PLC (GSK) and the Imagine Institute announced  they will collaborate on the development of medicines with the potential to treat Netherton Syndrome, a rare, genetically inherited, severe skin disorder.  
Under the terms of the agreement, the alliance will seek to build on the work of Prof. Alain Hovnanian at the Necker Children Hospital in Paris following significant breakthroughs in the understanding of the underlying disease mechanisms guided by the identification of the disease gene. Work on the project will be carried out within GSK and both at the Genetics Department and Inserm Transfert unit U781 at Necker Hospital in Paris.  
The University Hospital Institute Imagine and Inserm will receive success-based financial support from GSK linked to reaching agreed milestones, as well as an undisclosed upfront payment and royalties on sales from any product that is successfully commercialized out of the collaboration. Inserm Transfert will provide both parties with alliance management.
Netherton syndrome is one of the most severe genetic skin diseases of children and adults. No specific treatment is currently available, but recent progress made in the disease pathogenesis allow for the development of specific new drugs targeting key biological events.
"The partnership with GSK validates the role of the research in the area of novel therapeutic targets and its underlying mechanisms in combination with highest industry standards in drug discovery. For the patients, it also means the possibility of a novel treatment in an accelerated timeframe," said Hovnanian in a press release.
Code: E121223



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