Vertex and partner Johnson & Johnson have struck agreements with regulators on both sides of the Atlantic for a new Phase III trial of the closely-watched telaprevir for hepatitis C. This new late-stage study will test the therapy in 650 refractive patients and is intended to build on the data due from a separate trial of telaprevir in treatment naïve patients.
Vertex's share price has been tied to the fate of telaprevir, rising and falling with the drug's prospects. TheStreet notes that the developer isn't likely to file for approval of the drug until the second half of 2010, when it has the data on the treatment naïve group. A smaller study in treatment resistant patients has demonstrated efficacy for attacking the virus.
--see the Vertex release [1]
--read the story [2] from TheStreet.com
Related Articles:
Vertex shares rise on positive data for telaprevir [3]
Vertex shares jump on positive telaprevir data [4]
Vertex to Begin Phase 3 Development of Telaprevir [5]
Links:
[1] http://www.fiercebiotech.com/press-releases/vertex-pharmaceuticals-start-phase-3-realize-trial-telaprevir-treatment-failure-hcv-p
[2] http://www.thestreet.com/s/vertex-jj-to-begin-new-telaprevir-study/newsanalysis/biotech/10433829.html?puc=googlen&cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA
[3] http://www.fiercebiotech.com/story/vertex-shares-rise-positive-data-telaprevir/2008-06-09
[4] http://www.fiercebiotech.com/story/vertex-shares-jump-on-positive-telaprevir-data/2008-04-01
[5] http://www.fiercebiotech.com/press-releases/vertex-pharmaceuticals-begin-phase-3-development-telaprevir-investigational-hepatitis