New Obesity Drug Is Safe (Enough)

Orexigen's (NASDAQ: OREX  ) Contrave could join VIVUS' (NASDAQ: VVUS  ) Qsymia and Eisai and Arena Pharmaceuticals' (NASDAQ: ARNA  ) Belviq on the obesity market in the middle of next year after a trial measuring its safety read out today. The biotech plans to resubmit its marketing application to the Food and Drug Administration in the next few weeks.

The agency rejected Contrave in 2011 asking for a large trial to rule out cardiovascular risk. Orexigen worked out a deal with the agency -- called a Special Protocol Assessment -- that Contave could be approved if the trial showed that it was highly likely that the drug didn't double the cardiovascular risk.

The exact risk wasn't released because the trial is ongoing. Orexigen needs to keep the number a secret because it could influence the patients in the trial that are still taking Contrave or a placebo.

Most safety data
Orexigen and its marketing partner Takeda have the most cardiovascular safety data of the three new obesity drugs. Neither VIVUS nor Eisai and Arena Pharmaceuticals can say that their drugs don't double the cardiovascular risk.

It isn't really clear how much that will be worth at this point though. Saying the drug isn't really, really unsafe isn't saying very much at all. The FDA doesn't have any reason to believe Qsymia and Belviq cause a huge increase in cardiovascular risk; the agency didn't even make VIVUS and Arena Pharmaceuticals run safety trials.

It's not like the data show Contrave is producing a cardiovascular improvement. Orexigen and Takeda can't even say Contrave has the same cardiovascular risk with any degree of certainty.

Yet. Remember, the trial is still ongoing.

The problem here is that statistics is driven by the number of events. This interim look was conducted after 87 events -- heart attack, stroke, and cardiovascular death -- occurred in both treatment groups combined and was really only designed to rule out an excessive risk.

The subsequent looks after more events occur could increase the confidence that the drug has similar cardiovascular risk to placebo or might even show that the drug is improving cardiovascular outcomes. Losing weight should help patients improve their cardiovascular risk, so the latter isn't out of the question, although it might be hard to show a statistically significant improvement.

Making lemons into lemonade
At the time, the FDA's requirement to run a cardiovascular outcomes trial looked like a major setback for Orexigen, delaying the approval of Contrave by more than three years.

As it turns out, VIVUS and Eisai have had to work really hard to get doctors to warm up to obesity drugs. After Orexigen is approved, Takeda can piggyback on that effort and will have cardiovascular data that should make doctors even more comfortable. Eventually.

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Read/Post Comments (4) | Recommend This Article (2)

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 November 26, 2013, at 7:59 AM, AreaRich wrote:

    Brian can be found hanging in any tool shed. He's that tool they use to turn up dirt.

    Hoe.

  • Report this Comment On November 26, 2013, at 8:42 AM, bmc007 wrote:

    Right, after they all 'crashed & burned' on the VVUS pumping, it's time to try and run OREX up the flagpole. No worries, they'll have to buy ARNA at a much higher price if they don't buy/cover now.

  • Report this Comment On November 26, 2013, at 3:49 PM, plcfischer wrote:

    I think you are wrong about the following:

    Neither VIVUS nor Eisai and Arena Pharmaceuticals can say that their drugs don't double the cardiovascular risk.

    From the FDA's Belviq briefing document:

    pooled analysis of the Phase 3 echocardiographic data, the relative risk for FDA-defined valvular heart disease (VHD), defined as mitral regurgitation greater than mild or aortic regurgitation greater than trace was 1.16, with a 95% confidence interval (CI) of 0.81 to 1.67.

    As for the following:

    The FDA doesn't have any reason to believe Qsymia and Belviq cause a huge increase in cardiovascular risk; the agency didn't even make VIVUS and Arena Pharmaceuticals run safety trials.

    What are you talking about? The first part is obvious because both drugs are approved, but they did have to run safety tests. Where do you think the above data came from for Belviq?

  • Report this Comment On November 26, 2013, at 10:36 PM, Oozhe wrote:

    Orelli's comment about this trial's trying to show that a "doubling of risk" doesn't occur with Contrave is quite off-base.

    The trial design centers on establishing a hazard ratio of 1.3 or so , a 30% increase in CV risk, has not occurred - NOT a 100% increase in CV risk or a HR=2.0 that Orelli's "doubling of risk" implies.

    This sizable discrepancy quite thoroughly undermines his whole thrust in this piece - keeping within 30% of control on major adverse cardiovascular events is a very significant achievement of an efficacious therapy, especially where that 30% difference may well be of very small overall magnitude, ie, a 1.25% MACE rate for control vs a 1.6% MACE rate for Contrave.

    That's an overall difference of only one extra person with an event out of 300 patients which - while no extra events would of course be best - is still a significantly positive and substantial statement to make about an effective therapy's relative safety. And one that the FDA considers to be an acceptable trade-off for market clearance.

    Orelli needs to revisit this topic.

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