Envisioning 2.0

Earlier this year, I took a close look at Vertex Pharmaceuticals’ communications strategy for its new Hepatitis C treatment, VX-950. At the time, I cautioned against believing the hype about the drug until the company produced data supporting its safety and efficacy profile.

Right now it looks like VX-950 is on the right track. Standard & Poor’s recently conducted an analysis of the company suggesting that more positive data is forthcoming about the product. It says:

“In the second quarter of 2006, Vertex initiated the PROVE 1 (260 treatment-naive patients dosed with VX-950 compared with standard care in the U.S.) and PROVE 2 (320 patients in the EU) trials. The PROVE 1 trial is fully enrolled, and the company expects to release 12-week safety data for 80 patients by the mid- to late fourth quarter 2006. We believe that, based on prior safety data already presented, the odds favor a positive result from this trial. We think further positive results will have a favorable impact on the shares.

In the first quarter of 2007, the company expects to release three-month sustained viral response (SVR) data, which will measure the viral load 12 weeks after 12 weeks of treatment is stopped. In our view, this will be the key data for VX-950, as preliminary SVR is considered indicative of longer-term sustained response.

By mid-2007, Vertex expects to have 12-week treatment data for 180 patients and some follow-up data that it will use to design the Phase III trials. In all, the company believes that more than 1,000 patients will be enrolled in clinical trials by mid-2007.”

Clearly, Vertex has a long way to go before this drug is ready for review and potential approval by the Food and Drug Administration. However, these preliminary data indicate that the drug looks promising and will hopefully become a much-needed treatment option for those with Hepatitis C. (The FDA designated VX-950 for fast-track status in 2005.)

For more information on VX-950, please click here.

This entry was posted on October 10, 2006 at 10:18 am and is filed under The Pharmaceutical Industry. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.