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You Must REALIZE This Drug Works by Now

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Vertex Pharmaceuticals' (Nasdaq: VRTX  ) hepatitis C drug telaprevir clearly works. In trials with treatment-naive patients, telaprevir has been the clear winner over Merck's (NYSE: MRK  ) boceprevir, but the final phase 3 test -- in patients that had failed previous treatments -- was just as important.

There's big money to be made in the treatment-experienced patients for the second-generation drugs. The current options from Roche and Merck only cure about 50% of the patients treated with them, so there are a lot of patients sitting around with virus running through their blood stream waiting for next-generation drugs to become available.

In a clinical trial dubbed REALIZE, the drug was able to knock down viral levels in hepatitis C patients to undetectable levels -- essentially a cure -- in 65% of patients who had failed a previous therapy. Repeating the current standard of care -- the control group -- resulted in a 17% cure rate in these hard-to-treat patients.

On the surface, that 65% cure rate looks comparable to the 66% of the treatment-experienced patients who were cured on boceprevir, but the control group patients in Merck's trial were cured 21% of the time, meaning that telaprevir apparently did a better job. Vertex was nice enough to break down the cure rates between the treatment classes (those who had relapsed vs. those who had not responded vs. those who had partially responded) in its press release, but Merck didn't. So, we'll have to wait until Merck presents more data before we can get an accurate picture of how the two drugs match up in treatment-experienced patients.

Maybe the best news for Vertex and marketing partner Johnson & Johnson (NYSE: JNJ  ) was the lack of news about side effects. The drug has worked so well in the earlier trials that a new side effect was likely the only thing that could have kept the drug off the market. Just yesterday, Idenix Pharmaceuticals (Nasdaq: IDIX  ) halted clinical trials of two of its hepatitis C compounds because of side effects. Other treatments -- ViroPharma's (Nasdaq: VPHM  ) HCV-796 and InterMune's (Nasdaq: ITMN  ) danoprevir just to name two -- have run into issues. Telaprevir causes a rash in some patients, but it seems to be a minor enough side effect that it won't derail the drug.

With the risk nearly gone, Vertex's investors can sit back and wait for the biotech to start bringing in the revenue.

Vertex is up 238% since it was first recommended to Motley Fool Rule Breakers subscribers. What do David Gardner and his crew have up their sleeve today? Click here to grab a free 30-day trial subscription and see for yourself.

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Johnson & Johnson is a Motley Fool Income Investor pick. Motley Fool Options has recommended a diagonal call position on Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. True to its name, The Motley Fool is made up of a motley assortment of writers and analysts, each with a unique perspective; sometimes we agree, sometimes we disagree, but we all believe in the power of learning from each other through our Foolish community.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. 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 September 08, 2010, at 4:59 PM, HCVmaven wrote:

    We actually do know exactly who Merck enrolled in their treatment-experienced patients. From clinicaltrials.gov the patients who were enrolled are as follows:

    "This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in HCV-RNA viral load >=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and ribavirin."

    Those patients are the same as the combined relapser+partial responder subgroup in the telaprevir treatment-experienced study. The SVR for telaprevir in these patients was 78%, compared to 66% for boceprevir. The way to verify that the patients were the same is that the control group SVR rate was 21% for the Merck/boceprevir study and in this group of pts in the telaprevir study. Bottom line is that in the apples to apples comparison, telaprevir comes out ahead by a lot.

  • Report this Comment On September 08, 2010, at 5:06 PM, TMFBiologyFool wrote:

    HCVmaven,

    We know who enrolled, but we don't know the breakdown between the two groups (relapsers and partial responders) in Merck's trial. The control groups give you some confidence the fraction in each group is fairly close between the two trials, but I'd still like to see a complete breakdown before people start declaring a winner.

    -Brian

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