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Third Obesity Drug Moves Closer to FDA Approval

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Arena Pharmaceuticals' (NASDAQ: ARNA  ) Belviq, VIVUS' (NASDAQ: VVUS  ) Qsymia, and Orexigen's (NASDAQ: OREX  ) Contrave were rejected by the Food and Drug Administration within a few months of each other in late 2010/early 2011. But that's where the stories of these obesity drugs diverged.

Arena and VIVUS were able to get their drugs approved without running another long costly trial. Belviq was the first drug approved, but Qsymia actually launched first while the DEA held up Belviq to decide how likely it was to be abused. Both obesity drugs are now on the market.

Meanwhile, Orexigen is still waiting to get back in front of the FDA. Fortunately, it appears the biotech won't have to wait much longer.

The agency required Orexigen to run a large clinical trial to rule out the possibility that Contrave causes heart problems. The company enrolled more than 10,400 patients and then had to wait for enough patients -- 87 to be exact -- taking Contrave or placebo to experience a major adverse cardiovascular event before the data can be analyzed.

It's rather morbid to be rooting for patients to have a heart attack or stroke, but that's what Orexigen's investors have had to do over the last year or so.

This week, the independent data monitoring committee, which gets to see the unblinded data, told Orexigen that the 87th major adverse cardiovascular event is expected to occur within the next two months to allow the company to conduct an interim analysis.

Since this is a safety study, Orexigen just needs the Contrave group to have the similar frequency of major adverse cardiovascular events as the placebo group. If it could beat the placebo group, it would be one heck of a marketing tool.

While it seems possible that Contrave could lower the likelihood of cardiovascular events since patients should be healthier after losing more weight than the placebo group, it's probably asking a lot to see a statistically significant difference during the upcoming interim analysis. The study is expected to be completed in 2017, which is a more realistic time frame to see a difference in the two groups.

Late, but not out
Usually, launching third puts a company at a disadvantage. Doctors get used to prescribing the early movers, so the latecomers have to have a distinct advantage to take market share.

Fortunately for Orexigen, few doctors have prescribed either Qsymia or Belviq, so Orexigen won't be fighting to get them to switch.

Qsymia's and Belviq's launches have been relatively weak not because doctors don't want to prescribe the drugs specifically, but because they don't want to prescribe any obesity drugs. Memories of fen-phen and Abbott Labs' Meridia are still fresh in their minds, and it's going to take time and marketing muscle to convince them to prescribe them to patients in mass.

I think Orexigen will be fine if Contrave can produce positive data and the company resubmits to the FDA by the end of the year. VIVUS and Arena's marketing partner, Eisai, will have done all the heavy lifting, and Orexigen and its marketing partner, Takeda Pharmaceuticals, can swoop in with safety data that the other two don't have, potentially registering the best launch of the three.

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Read/Post Comments (7) | 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 August 29, 2013, at 3:31 PM, RSRdriver wrote:

    This company (Orexigen) will show both Arena and Vivus how it is done. I am convinced that the mistakes of the past have been rectified and the drug is what doctors are waiting for.

    Meanwhile, Belviq is slowly declining to the pps it should have had all along- sub $4.!

  • Report this Comment On August 29, 2013, at 3:39 PM, marp11 wrote:

    seeking alpha

    motley fools [perfect name]

    more i see the FUD



  • Report this Comment On August 29, 2013, at 3:48 PM, RSRdriver wrote:

    Ah,another wise and well thought out pump for ARNA! Well done Mr. Marp.

  • Report this Comment On August 29, 2013, at 4:53 PM, biogemfinder wrote:

    How many idiots does ittake to point out that Orexigen is going to file NDA for approval? It's comical at this point as if this is news....

  • Report this Comment On August 29, 2013, at 5:17 PM, earthunit wrote:

    Oresigen is not "CLOSE" to launching their obesity drug. Article makes it sound like it's imminent. Misleading, as usual, for MF.

    It will take months to get that "87th event".

    Then months more to compile the data.

    Then months more to resubmit to FDA IF the data comes out ok.

    Best case scenario is that Orexigen has a product on the shelf about 2 years from now!! THAT is NOT CLOSE!

    Both Belviq and Qsymia will be pretty firmly entrenched by then.

    Orexigen will NOT be fooling anyone to say that their drug is "safer".

  • Report this Comment On August 29, 2013, at 5:27 PM, RSRdriver wrote:

    Your right! ARNA is a lot closer to $4. and vivus will have the market to themselves for a while longer. Thanks!

  • Report this Comment On August 29, 2013, at 6:17 PM, Foreeverlong wrote:


    You stated, "Qsymia's and Belviq's launches have been relatively weak not because doctors don't want to prescribe the drugs specifically, but because they don't want to prescribe any obesity drugs. "

    I am in the health care industry working with physicians all of the time. Have you completed a survey of physicians that is a basis for making this statement? Because, I think that you are greatly generalizing the situation.

    Qsymia has not sold for reasons far different than what has occurred with Belviq. And, actually sales of Belviq have been far better than that of Qsymia. Eisai has intentionally taken a soft approach to marketing Belviq. Qsymia has been plagued with all kinds of side effects, including a pretty rigorous REMS.

    Frankly, I have find your articles to be almost amateurish, and certainly not insightful about what is going on with these drugs. They are more like quick flyby articles rather providing any real insight about any of these stocks and the companies involved.

    And, you say?

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