Orexigen Therapeutics ($OREX) finally seemed to be on the verge of FDA approval for its obesity drug after several years of delay and frustration. But now, the company gets to wait another three months as it hashes out details of a post-marketing cardiovascular outcomes study.
Orexigen's shares tanked on the news. But most market-watchers predict the pill will win the FDA's blessing when the time comes; the new FDA deadline is Sept. 11. And despite its late-to-the-party status--it's the third weight-loss pill in a new generation of treatments--the Orexigen pill may end up winning the popularity contest.
Sure, the drug appears less effective at pushing weight loss than Vivus' ($VVUS) rival Qsymia. Patients treated for one year lost about 5% of their body weight, while Qsymia patients lost about 9%, as The Street's Adam Feuerstein notes. But the Orexigen drug beats Belviq at the same measure. And Orexigen may have found a silver lining in that FDA-delay cloud; data from the cardiovascular study the FDA demanded before approval could potentially help the company make a safety case.
Another key difference among the three rivals? Sales and marketing.
Orexigen has a hefty marketing partner in Takeda Pharmaceutical ($TKPHF). The Japanese drugmaker plans to field 900 reps in support of the new pill. That beats the size of Eisai's Belviq-marketing force, even after two rounds of additional hiring; most recently, Eisai announced plans to add another 200 reps to its Belviq team, bringing the total to 600.
And it beats Vivus by an even bigger margin. No surprise, because unlike Arena and Orexigen, Vivus has no marketing partner for its obesity drug; its most recently job announcements involved layoffs, not hiring sprees.
Plus, Takeda's reps are experienced at talking about obesity-related health problems: They've been marketing the company's diabetes pill Actos, and overweight people are more likely to develop the disease. Actos has had its own challenges, but along the way, its reps worked with endocrinologists and primary-care doctors alike. In short, Takeda's sales folks have contacts, and they're not afraid to use them. In fact, as FierceBiotech notes, Orexigen CEO Michael Narachi has repeatedly pointed to Takeda's sales prowess as reason for optimism.
Eisai's sales ramp-up shows that putting more reps to work can boost sales. Together with a new direct-to-consumer ad campaign, that expansion is delivering increases in prescription numbers--up almost one-third in the first quarter--and revenue, too. Weekly script counts show continued growth so far this quarter.
The question now is whether Orexigen's pill and Takeda's sales force can shove Belviq and Qsymia aside. The answer? They may not have to. The obesity market is woefully behind the rest of the pharma world, what with long-past safety scandals, the stigma of obesity, the skepticism of payers--and so on. Vivus, Arena ($ARNA) and Eisai have worked hard to cast obesity as a no-embarrassment-required disease that needs treatment. They've also worked hard to win reimbursement from payers, and succeeded. Takeda and Orexigen will add their voices to the same arguments.
So, a new launch may simply help the current players develop the market further. That's the theory, anyway--everyone's marketing, Takeda's included, will make the weight-loss pie bigger, leaving plenty of room for rival products. Sounds like wishful thinking to us, though; maybe the market will grow long-term, but in the short term, we'll see a scramble for share.
Anyone care to guess who'll win? A couple of analysts have unveiled their sales estimates, and they put the Takeda/Orexigen pill in the lead. Piper Jaffray analyst Charles Duncan figures Orexigen's pill can nab $1.5 billion in sales by 2020, with Vivus counting about one-third as much on Qsymia, CNBC reports. Wells Fargo's Matthew Andrews forecasts $1.2 billion for Orexigen/Takeda, partly because of Orexigen's plans to develop the drug for Type 2 diabetes; he sees just $481 million for Belviq and $396 million for Qsymia.
Editor's note: This story was updated to reflect the FDA's decision to delay an approval decision till September.