Recs

7

Dang! This Drug Is Shining Brighter

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It just keeps getting better.

Not only does adding Vertex Pharmaceuticals' (Nasdaq: VRTX  ) telaprevir onto the standard of care for hepatitis C increase the likelihood of a sustained viral response -- essentially a cure for patients -- but it allows many patients to take current offerings for less time.

In a phase 3 trial dubbed Illuminate, Vertex compared 24 weeks of treatment with the current standard of 48 weeks. For patients who had undetectable levels of the hepatitis C virus early in treatment -- after four weeks and 12 weeks of treatment -- 92% of them were cured after 24 weeks of treatment compared to 88% cured after taking a full course of 48 weeks.

Cutting the time on the standard of care is a big deal because Roche's Pegasys and Merck's (NYSE: MRK  ) Pegintron have nasty side effects that make many patients feel horrible. In the trial, 65% of the patients had early response rates that would be eligible for the shortened treatment.

Merck, which is developing competing hepatitis C treatment boceprevir, also tried the same trick of separating out early responders. But Schering-Plough, which owned the drug before Merck bought the company, set up its trial to treat the early responders for 28 weeks, a month longer than Vertex treated its. Merck hasn't broken out the data for just early responders yet, but the cure rate for those who got response-guided therapy was 63%, lower than the 72% for all the patients taking telaprevir.

Vertex has one more phase 3 trial to report about patients who have failed prior hepatitis C treatment. Assuming that trial goes as well as the first two -- first results are expected next month -- Vertex and marketing partner Johnson & Johnson (NYSE: JNJ  ) should have no problem getting the drug approved and then persuading patients to take it. I wonder if Eli Lilly's (NYSE: LLY  ) executives cringe at every data release, wondering what could have been.

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Vertex is up 240% since the analysts at Motley Fool Rule Breakers recommended it in early 2005. To read the original recommendation and our analysts' current thinking, grab a free 30-day trial subscription to the high-growth newsletter.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Johnson & Johnson is a Motley Fool Income Investor selection, and Motley Fool Options recommended buying calls on the stock. The Fool has a disclosure policy.


Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On August 12, 2010, at 2:27 PM, hepcisme wrote:

    One thing that is never talked about in these assessments is that the Merck/Schering studies used a 4-week run-in of Peg/Riba that will accomplish 2 things. First, it will identify patients who are HCV-RNA negative at week 4 - these patients have a 92% SVR with just Peg/Riba and may not need the PI at all. Secondly, it will identify IFN insensitive patients who are unlikely to respond to even with a PI and who are likely to develop resistance. The 24 weeks of treatment with the PI is the same, and as I am sure you know if you are well informed, just because the study used 28 weeks does not mean that 24 might not be enough. Let's stop the Vertex cheerleading until all of the data are out.

  • Report this Comment On August 13, 2010, at 2:01 PM, hepcisme wrote:

    Wait until all the data is out as opposed to Vertex' clever press release policy. First, the control arm response rate is significantly higher in the Vertex study. Then there is the issue of severe rash, which has gotten almost no discussion in the media. The grapevine word is that several patients reuired hospitalization in the ICU due to the severe rash. Rather than let investment fund advisors, many of whom have been touting Vertex for several years determine the pros and cons of each therapy, let all the data be reported first. The differences in response could be a matter of differences in the percentages of genotype 1a and 1b patients in the respective trials. None of this information has been reported as of yet.

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