FDA approves Vivus' weight loss drug Qsymia

The FDA on Tuesday approved Vivus' Qsymia (phentermine/topiramate), which was formerly known as Qnexa, for use in people who are obese or overweight and have at least one weight-related condition such as hypertension, diabetes or high cholesterol. In April, the agency extended its review of the therapy by three months after the drugmaker submitted a risk evaluation and mitigation strategy (REMS) as requested by regulators.

Qsymia is the second weight loss drug approved by the FDA in less than a month, following the clearance of Arena Pharmaceutical and Eisai’s Belviq (lorcaserin) on June 27. Previously the agency had not approved a new drug for long-term weight loss since 1999.

Vivus president Peter Tam noted that the company plans to begin selling Qsymia, the name of which was changed due to concerns it could be confused with other therapies, in the US in the fourth quarter. The executive suggested that Qsymia could be available ahead of the launch of Belviq because its main ingredient, phentermine, has already been classified by the Drug Enforcement Administration, whereas Arena and Eisai’s therapy is still awaiting classification. However, he suggested that market timing won’t make much of a difference for either drug, adding that "this is a very large market. There aren’t a lot of treatments that are working. We don’t think it will make much of a difference."

Barclays analyst Atsushi Seki said "the new addition will expand the overall market," noting that "Vivus will have some restrictions to sell Qsymia as the drug is very effective, which also means the side effects will be stronger." Seki suggested that could advantage Arena and Eisai’s Belviq, which may generate peak annual sales of $1.5 billion. However Cowen & Co. analyst Simos Simeonidis remarked that Vivus' product "has a significant advantage over Belviq, given its considerably better efficacy." He added that there was likely room for both drugs, noting that "the majority of obese patients wanting to try drug therapy will end up seeing both drugs, regardless of which one they take first."

Still, Vivus is building its sales capacity to market the drug itself in the US and will hire the contract sales organisation PDI to have 150 sales representatives on board. "We’re going to have to grow our sales organisation in order to support the primary care market," Tam remarked. Outside of the US, the executive noted that "we are talking to companies we believe that are capable of supporting our product," but noted that "we are not interested in being acquired as we feel we can do a very good job in the US." He added that the drugmaker is in discussions with a number of large drugmakers about such a partnership, noting that "you can probably count them on two hands."

Analysts estimate that Qsymia sales may reach $1.2 billion in 2016.

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