The corks were popping at Vivus last evening. FDA gave its final approval to the diet drug Qsymia, and it was a long time coming. But what happens after the approval celebration dies down? The same tricky, fraught-with-peril endeavor that follows any new drug nod: The launch.
And this one will be closely watched, just as its path toward approval was. Hopes are high; analysts now see Qsymia selling $1.2 billions' worth by 2016. But Vivus ($VVUS) is a small company with little marketing experience and no army of sales reps, aiming to promote a drug aimed at the primary-care market. And it will compete with another newly minted weight-loss med, the Arena Pharmaceuticals ($ARNA) drug Belviq.
So, Vivus has turned to PDI, a contract sales group, to staff the launch, The idea is to sell the pill through mail-order pharmacies first, President Peter Tam told Bloomberg. The company is working with FDA to gain access to retail drugstores. "We feel we can do a very good job in the U.S.," Tam said.
Nitty-gritty deails about the approval could make a difference to the sales effort. The drug's label will include warnings about the risk of heart-rate increases and birth defects. But Cowen & Co.'s Simos Simeonidis figures the label is "fairly benign" and won't deter "a significant portion" of patients from using the drug, according to an investor note.
Plus, Simonedis says, Vivus could well beat Belviq to market, because the latter has to undergo Drug Enforcement Administration review as a controlled substance, which can take up to 6 months. Also, whereas Belviq patients are told to discontinue after 12 weeks if they haven't achieved a 5% weight loss, Qsymia patients are told to evaluate their progress by 26 weeks. Qsymia data showed it helped patients lose more than 10% of their body weight, on average, compared with Belviq's 5%.
In any case, analysts see room for both drugs in the marketplace. Obesity is an enormous problem in the U.S., and even if a third in-development diet drug hits, they could all succeed. "This is a very large market," Tam told Bloomberg. "There aren't a lot of treatments that are working."
Meanwhile, Vivus is scouting for foreign partners, he said. "[W]e are talking to companies we believe are capable of supporting our product outside of the U.S. There are quite a few."