by James Brumley | December 2, 2013 10:55 am
The good news is, it looks like Orexigen Therapeutics (OREX) is going to be ushered into the relatively exclusive club of FDA-approved diet-pill manufacturers. The bad news is, the club’s only two current members — VIVUS (VVUS) and Arena Pharmaceuticals (ARNA) — haven’t exactly been lighting it up when it comes to sales.
Granted, both biopharma companies in the diet pill business encountered unexpected problems following the approval of their respective drugs. But still, getting the nod from the Food and Drug Administration is a big deal.
The big question is: What are the odds Orexigen’s weight-loss drug Contrave will be able to meaningfully break into this tricky market? Or, asked more specifically, is there a chance that Contrave could hit a headwind similar to the ones that VIVUS’ Qsymia and Arena’s Belviq hit?
Just so there’s no confusion, Orexigen’s diet drug Contrave has not yet been approved by the Food and Drug Administration. The company simply believes its research has shown the drug does NOT increase heart-related risks, which is the concern that prompted the FDA to reject the drug back in early 2011.
It should be noted, however, the administration has become remarkably open-minded regarding diet pills lately; the approval of Qsymia and Belviq in the middle of last year was the first time in more than a decade that a pill of that ilk had won the Food and Drug Administration’s proverbial blessing.
As for the odds that Orexigen’s Contrave will ultimately be approved, the professional biopharma handicappers are saying yes, the diet pill will get the marketing green light. The basis for the assumption is that this drug is arguably less worrisome than diet drugs already approved by the FDA.
Contrave is the combination of two drugs already approved by the Food and Drug Administration: sustained-release naltrexone, and bupropion. The combination of drugs is believed to decrease appetite by balancing a person’s energy levels.
The two drugs together increase dopamine activity (leading to a reduction in appetite and increase in energy output by increasing activity of pro-opiomelanocortin neurons), while simultaneously blocking opioid receptors on the pro-opiomelanocortin neurons (which increases pro-opiomelanocortin activity). In English, Contrave reduces appetites and causes the body to burn more of its stored energy.
If the idea rings a bell, that may be because Qsymia is also the combination of two distinct, already-approved drugs phentermine and topiramate. Phentermine is an appetite suppressant, and topiramate is believed to increase satiety — the feeling of fullness.
Arena’s Belviq pills only contain one active known drug, though it operates using the same basic approach that Contrave and Qsymia use. That is, Belviq activates the brain’s serotonin receptors, which heighten the feeling of satiety.
While the exact mechanism of action may not be the same, it’s not like Orexigen Therapeutics is going to ask the Food and Drug Administration to approve something it hasn’t seen — and approved — already.
But an approval hardly guarantees success. Just ask VIVUS and Arena Pharmaceuticals.
Although Belviq and Qsymia were deemed to be surefire winners before either was approved in mid-2012, neither has been especially impressive. Even after Belviq got past its nagging Drug Enforcement Agency hurdle in May, it failed to take off. (Belviq has the potential to be abused, and therefore needed to be classified by the agency before it hit the market).
Sales of Belviq only totaled $4.8 million in Q3, while Qsymia’s revenue in the third quarter — after being on the market for more than a year — was a measly $6.4 million. That’s a far cry from the $12 million the pros were expecting from Qsymia, and nowhere near the annual sales of $1 billion some pros are expecting by 2019.
Belviq also has a long way to go before reaching the annual sales level of more than $400 million that some analysts had predicted for 2015.
Fans and supporters say these companies need time to develop sales momentum, and that’s basically true. These are exceedingly slow starts, however, and they suggest the opportunity may be far weaker than first assumed.
The hangup is, by and large, a stigma that has stuck with the diet pill industry since the fen-phen fiasco of 1997. That particular drug was eventually determined to cause heart problems, leading to a class action lawsuit that ended up costing billions of dollars worth of damage settlements.
Though it was fen-phen’s makers and not the prescribing doctors that ended up paying the direct price, doctors can still be found to be guilty by association in the court of public opinion. Physicians are understandably not in a hurry to take on that kind of risk again, particularly when better diets and more exercise remain (in general) a more effective approach to weight-loss.
Arena and Vivus both climbed on hype and hope … all the way up to an actual FDA approval. However, once hope became reality and each company won the approval it was seeking, reality set in. Both companies’ current stock price is well beneath the values seen at the time of their respective drugs’ approvals.
Technically safe or not, Contrave isn’t apt to be viewed as significantly different than its existing competition. You may not want to get married to Orexigen on hopes that it’ll be an exception to the industry’s norm so far. The stock is already down 5% today, and even if it does climb back up in anticipation of approval, it’s likely to plunge afterward.
As of this writing, James Brumley did not hold a position in any of the aforementioned securities.
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