Is a VIVUS Win Arena's Loss?

Look at almost any article about the potential for approval of VIVUS' (Nasdaq: VVUS  ) Qnexa this week, and you'll find a few Arena Pharmaceuticals (Nasdaq: ARNA  ) supporters bashing Qnexa. See my article from a few days ago for examples.

I think their animosity might be a little misguided.

Arena's marketing partner Eisai will soon launch Belviq into a wide-open obesity market. Roche sells Xenical, but it's not much of a competition. Abbott Labs (NYSE: ABT  ) pulled its obesity drug Meridia off the shelves in 2010. The approval of Qnexa would add legitimate competition.

But that's not necessarily a bad thing. Sure, any patient taking Qnexa is one fewer patient who could be prescribed Belviq, but many patients prescribed Qnexa won't respond to the drug, giving Belviq a chance to pick up the leftovers.

More important, though, the launch of two drugs has the potential to increase the overall obesity market faster than one sales team could do. It's very likely that doctors will prescribe both drugs to different types of patients. Keeping obesity drugs on doctors' minds and pointing out their availability to patients will increase prescriptions of both drugs no matter which drug the promotional material is for.

We don't know what Qnexa's label will look like, but it's almost guaranteed that the FDA will recommend doctors not give it to patients who are pregnant or might become pregnant; Qnexa contains the same active ingredient as Johnson & Johnson's (NYSE: JNJ  ) Topamax that's been shown to cause birth defects in babies born to mothers who took it.

Direct-to-consumer advertisements by VIVUS that drive patients intending to become pregnant to ask their doctors about Qnexa could result in the doctor prescribing Belviq instead of just sending the patient home empty-handed.

Only time will tell if the added free advertisement from VIVUS makes up for the added competition, but I don't see Qnexa's approval as the biggest obstacle for a successful launch of Belviq.

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Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Abbott Laboratories and Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Johnson & Johnson and have recommended creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.


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  • Report this Comment On July 16, 2012, at 4:46 PM, genesis667 wrote:

    Qnexa is not a credible threat to Belviq....VVUS created nothing in Qnexa, they took two old relic drugs that someone else created and mashed them together...Voila, I give you QNEXA!

    The biggest scam has been perpetrated by Wall Street for backing this company and making it's founders very wealthy for doing nothing more than repackaging someone else's drugs. Real medical breakthrough that is!

    VVUS even went as far as to try and patent the drug ARNA created...Hows that for business ethics!

  • Report this Comment On July 16, 2012, at 5:09 PM, ATLnsider wrote:

    Brian;

    As you may know, all prescription weight loss or obesity drugs are not intended for pregnant women or women who are planning to become pregnant. This includes Belviq (Lorcaserin).

    Belviq is a Pregnancy Catergory X drug, and it is contra-indicated for pregnant women, women who are planning to become pregnant, and for women who are nursing. Here is an excerpt from the Belviq label:

    "BELVIQ is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Maternal exposure to lorcaserin in late pregnancy in rats resulted in lower body weight in offspring which persisted to adulthood. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus".

    Here is the link to the Belviq label:

    http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022...

  • Report this Comment On July 16, 2012, at 5:45 PM, genesis667 wrote:

    Belviq doesn't cause birth defects as Topirimate clearly does....

    During Q's trials, 34 women became pregnant, 19 of those women had their babies....Now, if 34 women became pregnant under the best of circumstances, that included birth control monitoring and counseling, what will happen with Qnexa when it's released to the public.

    Tens of thousands of pregnant women will have to make the decision of aborting their baby or risk having a baby born with a lifelong birth defect...

    That is one screwed up risk reward ratio!

  • Report this Comment On July 16, 2012, at 7:07 PM, ATLnsider wrote:

    There are several errors in your comments.

    (1) You are right that there were 34 pregnancies during the Qnexa clinical trials. However, you left out the fact that there were 0 reports of any birth defects, and 0 reports of any oral clefts.

    (2) There were 54 unplanned pregnancies for women of child-bearing potential (WOCBP) who took Lorcaserin (Belviq) during the clinical trials.

    This was true even though all WOCBP in the Lorcaserin clinical trials were required to take birth control. Out of these 54 pregnancies, only 18 healthy babies were born. There were 20 abortions, 8 miscarriages and 8 unknown outcomes.

    You can take a look at Table 46 on page 129 of the Arena Lorcaserin Adcom briefing document. Here is the link:

    http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMe...

    So, as you can see, despite the fact that all women of child-bearing potential were required to use birth control, and undergo counseling, there were significantly more unplanned pregnancies in the Lorcaserin clinical trails(54) than there were in the Qnexa clinical trials (34).

    Fortunately, for Vivus, Qnexa's ingredients have been on the market since 1959 (Phentermine over 53 years) and 1996 (Topiramate over 16 years). These drugs have been used by over 100 million patients since they were approved by the FDA. The safety histories of both Phentermine and Topiramate are well-documented and well-established.

    I am confident in the safety of Phentermine and Topiramate, but the jury is still out for Belviq. We will not know how safe Belviq is until it has been on the market for at least 5 to 10 years, and it has been used by tens of millions of patients.

  • Report this Comment On July 16, 2012, at 9:11 PM, genesis667 wrote:

    You conveniently left out the fact that the FDA said that a sample size of 19 women was far to small to draw any conclusions from.

    Belviqs trials were also done on over 8,000 people, far more than was done for Qnexas trials.

    As if the birth defects weren't bad enough, and they are in my opinion, I understand birth defects are of no concern to VVUS shareholders, as evidenced by your willingness to brush them off as irrelevant, It is well documented that Topirimate causes birth defects.

    A simple Google search will yield thousands of documents questioning the safety of both drugs used to make Qnexa.

    5 people also had heart attacks during Qnexas trials, none on the placebo side, The FDA is also concerned with increased heart rate caused by Qnexa.

    Since part of Qnexa is a methamphetamine, the increased heart rate and subsequent heart attacks should come as no surprise....

    I expect the FDA will want it closely monitored for cardiac events in addition to a possible patient registry for women, if they even decide to approve it.

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