After gaining FDA approval for its obesity drug Qsymia (phentermine/topiramate) last month, Vivus Inc. went to work preparing for a fourth-quarter launch of the drug. (See BioWorld Today July 19, 2012.)

"I can tell you within our company it was not a celebratory mode [after the approval], because we understand that this is kind of an interim thing. For those of you who like sports, it's kind of a jinx to start celebrating when you win your first playoff game because the goal is to win the championship. We have to deliver this product to patients. And we will not be satisfied until we get the product out," Vivus' CEO Leland Wilson said at the company's analyst day last week.

As a small company, Vivus elected to outsource the supply chain with ScinoPharm Taiwan Ltd. providing the API, Catalent Inc. manufacturing Qsymia, and Cardinal Health Inc. distributing the drug.

The sales management team will be employees of Vivus, but the approximately 20 managers will oversee a 150-person sales force that are employed through a contract with PDI Inc., which provides outsourced sales and marketing expertise.

Even with all the components in place, Vivus has plenty of challenges; no obesity drug has ever reached blockbuster status.

Vivus has identified 15,000 doctors who write most of the prescriptions for the obesity drugs, but the key to growing the market lies in an additional 10,000 doctors who prescribe few obesity drugs, but write a substantial number of prescriptions for co-morbid conditions such as hypertension, diabetes and high cholesterol.

A majority of the patients who are prescribed drugs for co-morbid conditions are also appropriate candidates for Qsymia. For example 80 percent of patients taking metformin or Januvia (sitagliptin, Merck & Co. Inc.) are within Qsymia's label. That's true of 70 percent for patients on statins and 60 percent of patients taking medications for treating hypertension.

But Vivus' management isn't delusional in thinking that those doctors will start treating obesity just because Qsymia is available.

"If it is one of the physicians not currently using anti-obesity meds and is not accustomed to treating obesity medically, then I think an education process needs to go on," explained Mike Miller, senior vice president and chief commercial officer at Vivus.

Qsymia is covered under a risk evaluation and management strategy (REMS) that will restrict the drug's distribution to mail-order pharmacies because of the risk of orofacial cleft if patients are exposed during the first trimester of pregnancy. Vivus hopes to make the prescription writing process as simple as possible by giving doctors the option to fax prescriptions directly to the pharmacies or for patients to send in the prescription directly.

While the mail-order distribution will make sales challenging, the upside to having the REMS program is that Vivus will get a list from the pharmacies of every doctor who prescribes the drug. The list will be then used to encourage doctors to take the training program that covers patient selection and how to mitigate risk. But Vivus can forward the information on to its sales reps, providing real-time feedback of doctors that prescribe the drug.

Analysts were mixed in their views on Qsymia's prospects.

Michael G. King, analyst at Rodman & Renshaw LLC, is generally bullish concluding that, "the unmet need in the obesity space and pent-up demand for an effective anti-obesity therapy will lead to a solid launch."

While Cowen and Co. analyst Simos Simeonidis isn't convinced of Qsymia's prospects, at least in the short term. "We also continue to believe that the initial ramp-up will be slower than some investors' expectations," Simeonidis wrote.