Vivus Inc. President Peter Tam said U.S. health regulators' approval to sell its diet pill Qsymia through retail pharmacies removed "a major barrier" to the drug's adoption and paved the way for a direct-to-consumer campaign to be launched later this year.
"We are keeping all options open in terms of increasing the commercialization support for Qsymia," Tam told Reuters in a phone conversation from his Mountain View, California office.
Since Qsymia's launch in September, Vivus has been struggling to improve sales of the drug.
The company has earlier blamed weak adoption of the pill on limited reimbursement and a restricted Risk Evaluation and Mitigation Strategy (REMS), or a risk managing plan, that allows the drug to be sold only through mail-order pharmacies.
The U.S. Food and Drug Administration accepted Vivus's proposal to modify the REMS and allow Qsymia's sale through certified retail pharmacies, where the drug is expected to be available within 90 days, the company said.
Vivus's largest shareholder, First Manhattan Co (FMC), which has been critical of the company's marketing plan and pushed for a partnership on the drug, stepped up its attack last week when it said it anticipated the company to get an REMS modification, but that would not guarantee Qsymia's success.
President Tam refused to comment on FMC's statement, but said "the REMS modification was a monumental task. It's not something about which anyone can say — oh, it was expected."
"We have previously guided to the Street that typically the FDA would take six months to review and render a decision [on an REMS modification]. Today, is exactly six months from the time we submitted."
Tam added that the company was in discussions with insurers and pharmacy benefit managers to improve Qsymia's reimbursement, but it was still scouting for a buyer for its yet-to-be-launched erectile dysfunction drug Stendra that won U.S. regulators' approval in April 2012.
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