How Bad Is This Delay for Orexigen Therapeutics, Inc?

Orexigen Therapeutics (NASDAQ: OREX  ) recently announced that the Food and Drug Administration was delaying an approval decision on the biotech's obesity drug Contrave for three months.

On the surface, the delay seems harmless. In the press release, Orexigen said that "[d]iscussions around the package insert and other post-marketing obligations are ongoing." That's biotech code for "we're going to get approved" since there's no reason for the FDA to discuss post-marketing obligations if the agency isn't going to authorize Orexigen to market the drug.

What's a little worrisome is that the company's ongoing outcomes study of Contrave was the basis for reapplication after the FDA rejected the initial application because of the potential for the drug to cause heart problems. Orexigen seemed to have met all the requirements the FDA set out, but investors only get Orexigen's version of the requirements. Perhaps the FDA is moving the goal posts, or maybe Orexigen didn't quite understand what the agency wanted.

The delay isn't likely to much benefit Orexigen competitors Arena Pharmaceuticals (NASDAQ: ARNA  ) and VIVUS (NASDAQ: VVUS  ) . As senior biotech specialist Brian Orelli and health-care analyst David Williamson discuss in the video below, sales of Arena Pharmaceuticals' Belviq and VIVUS' Qsymia are so low that Contrave taking market share won't materially affect them. In fact, launching Contrave -- whenever it happens -- could benefit Arena and VIVUS because the market will hopefully expand with an additional set of sales reps talking to doctors about the obesity market.

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  • Report this Comment On June 24, 2014, at 8:16 AM, MRAY wrote:

    Hi guys, BO & DW. I fail to understand your article.

    BO Your comments :

    1. Orexigen seemed to have met all the requirements the FDA ,- or maybe Orexigen didn't quite understand what the agency wanted.

    MRAY: If you understood better than Orexigen then what are the requirements kindly advise ?

    2 BO comments: The delay isn't likely to much benefit Orexigen competitors.

    MRAY - It will give them some more time of less competition.

    3. BO comments: sales of Arena Pharmaceuticals' Belviq and VIVUS' Qsymia are so low that Contrave taking market share won't materially affect them. In fact, launching Contrave -- whenever it happens -- could benefit Arena and VIVUS because the market will hopefully expand with an additional set of sales reps talking to doctors about the obesity market.

    MRAY- I fail to understand the logic again. Do you mean that Arena and Vivus fail to promote their own brand name and Orexigen will expand their market share to their benefit?

    So this is the reason why Novo Nordisk NVO is trying to expand the use of its own drug for the use of obesity to benefit all other companies.!!

  • Report this Comment On June 24, 2014, at 9:23 AM, hengstrom wrote:

    Clinical trial data for use of the combination of Belviq and phentermine is due out around the time that Orexigen's next FDA decision data is scheduled for: animal data and anecdotal evidence seems to be pointing to weight loss in the area of 15% over 12 weeks: that would make Orexigen's overpriced combination of 2 generics with side effects irrelevant from the start.

    This is probably good for Takeda and Orexigen: they will probably decide not to waste their time trying to market Contrave and will move on to greener pastures quickly.

  • Report this Comment On June 24, 2014, at 11:48 AM, aldehyde wrote:

    hengstom explain these side effects

  • Report this Comment On June 24, 2014, at 1:33 PM, gazoo99 wrote:

    Orex's Contrave Side Effects:

    Now, the combination of bupropion and naltrexone is being studied for possible weight-loss effects through its synergistic action on appetite signaling and the mesolimbic reward system.

    U.S. investigators randomized 1742 obese patients (85% female; mean body-mass index, 36 kg/m2) without diabetes or cardiovascular disease to fixed-dose combinations of bupropion (180 mg twice daily) and naltrexone (either 8 mg or 16 mg twice daily) or to placebo for 52 weeks (following 4 weeks of dose escalation). The study was supported by a company that has combined the two drugs in a single tablet.

    About half of the people in each group withdrew from the study, most commonly during the first 16 weeks. In an intention-to-treat analysis, mean weight loss was significantly greater in the high- and low-dose bupropion/naltrexone groups than in the placebo group (–6.1%, –5.0%, and –1.3%, respectively). Adverse effects in the bupropion/naltrexone groups (e.g., nausea, vomiting, constipation, headache, dizziness, dry mouth) were mostly mild-to-moderate and transient.

    Further studies should include broader populations and head-to-head comparisons of bupropion/naltrexone with other active weight-loss agents. An editorialist warns that known psychiatric and cardiovascular side effects of the two component drugs will require careful evaluation.

  • Report this Comment On June 24, 2014, at 2:48 PM, gazoo99 wrote:

    Side Effects.......

    Precautions

    Bupropion should not be taken by people who suffer from epilepsy or other conditions that lower their seizure threshold, such as:

    Benzodiazepine withdrawal

    Alcohol withdrawal

    Anorexia nervosa

    Bulimia nervosa

    Active brain tumors.

    In addition, people who take monoamine oxidase inhibitors (MAOIs) should avoid taking bupropion because of severe adverse effects. Bupropion interacts with CYP2B6 inhibitors, including:

    paroxetine

    sertraline

    fluoxetine

    diazepam

    clopidogrel

    orphenadrine.

    Caution should be taken when prescribing the drug to patients with hypertension and kidney disease.

    Side effects

    Common side effects of Wellbutrin include:

    Dizziness

    Anxiety

    Stomach cramps

    Dry mouth

    Restlessness

    Irregular bowel movements

    Nausea

    Headache

    Diarrhea

    Difficulty sleeping.

    Less frequent side effects of Wellbutrin include:

    Confusion

    High blood pressure

    Migraine

    Blurred vision

    Confusion

    Itching

    Hives

    Fever

    Throat irritation

    Hearing problems

    Irritability.

  • Report this Comment On June 24, 2014, at 3:15 PM, AlanPithy wrote:

    Additional FDA scrutiny on your data is rarely a good thing. Maybe FDA will approve the drug 90 days late. Or maybe there is something wrong with the way the trial was managed, or some surprising new information gleaned from the trial. From listening to the management and reading a BofA-ML report, it seems there will be some difficulty keeping the LIGHT study data free from bias. Personally I find it hard to believe FDA concerns about Contrave's heart risk could be lifted by what OREX executives characterized as showing "less than 2 times the number of MACE events in the drug arm vs placebo arm" from the LIGHT study's first interim analysis. The interim data would seem to come from too few events, too few people, and with not enough time to have confidence in the data. There would be a lot of randomness in the early data from people who have only been enrolled a short time. But since the two generic drugs used to mix Contrave have been on the market several decades perchance the FDA is not as worried. Still makes me wonder why they bothered asking for a 4 year LIGHT study if they would be convinced by early interim data released before the study was fully enrolled or before they were enrolled for any significant amount of time. Perhaps we'll learn more about that in time.

    It also seems that the delay has something to do with whether they can both keep this trial going and using the data they learned to day without introducing bias into the future data. If they release the interim data or use the interim data to design the label or marketing tools they will bias the ongoing LIGHT study. Yet the FDA is unlikely to allow OREX to just scrap the ongoing LIGHT trial and start over with a new post-marketing study. Perhaps the FDA will agree to a compromise solution and let OREX market Contrave this year, but maybe the FDA will ask them to continue running the LIGHT study until more MACE events have occurred or more time has elapsed in order to increase confidence in the statistical data. They will need to be confident not just in what they have but in what they will learn from future data, and they cannot compromise future data for the sake of a marketing label today. We'll find out their decisions soon enough, and their decision could help inform future marketers on how (not) to design future studies with interim data releases.

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