The FDA isn't happy with Orexigen ($OREX), which put out some early positive cardio data for obesity drug Contrave Tuesday. The way the FDA sees it, the data were too early. In fact, it had already asked Orexigen for a second outcomes study because it had shared the info with too many people. But meanwhile, the new stats have changed some analysts' minds about Contrave's safety profile--something that could give it a leg up in a crowded market going forward.
Going against the longtime concerns that weight-loss drugs can cause heart damage, the interim analysis of Contrave data actually suggests the therapy can reduce major adverse cardiac events, the California biotech said in a regulatory filing.
Of course, Orexigen needs to look at more patients to really pinpoint Contrave's effect on cardiovascular outcomes. The FDA certainly agrees, and Orexigen shot itself in the foot when it comes to a near-term change to Contrave's label. The early chatter inside the company--and now outside--means the FDA wouldn't entertain any changes based on the current study. But RBC Capital Markets analyst Simos Simeonidis said he still views the news as "very significant."
"What makes these data even more important, in our view, is that the 9,000-patient LIGHT study was a great representation of the population that would use the drug in the real world," Simeonidis said in a note to investors. The group had an average BMI of 37, while 85% had Type 2 diabetes, 88% were on lipid-lowering drugs, 93% were on blood pressure meds, and almost a third were diagnosed with heart disease, he pointed out.
The potential heart benefit could give Contrave an advantage over a pair of rivals that preceded it to market. Both Qsymia from Vivus ($VVUS) and Belviq from Arena ($ARNA) have been around since 2013, though they've gotten off to slow starts.
The promising CV numbers could evaporate as the study wears on, of course. But even so, healthcare providers' opinions of the treatment have "improved significantly" just by virtue of the fact that Contrave appears not to do any cardiac harm, Leerink Partners analyst Paul Matteis wrote in an investor note. "Specialists with whom we spoke were very surprised by the interim findings and believe the new CV data increase the proportion of their (patients) who are Contrave candidates," he said.
All things considered, some analysts--including Simeonidis--expect Contrave to eventually outdo the rest of the weight-loss-drug pack, and so far, launch numbers have it on track to do just that. The med has raked in $12.3 million in gross sales over the first 10 weeks of launch, and growth seems to be coming not only from physicians who traditionally write obesity scripts, but also those who historically have been non-writers, he wrote. Discounts are playing a role: Net of rebates, Contrave sales amounted to $6.5 million for the same period.
Its differentiated clinical profile, commercial support from partner Takeda and delayed market arrival "will help make Contrave's launch much more successful than its two competitors'," he predicts. "They may even make it the first primary care-like launch in obesity."
- read Orexigen's 8-K
Special Report: Limited attention span? Focus on these market shake-ups in 2015