April 10, 2013 / 2:30 PM / in 5 years

First Manhattan says risk management change not enough for Vivus drug success

April 10 (Reuters) - Vivus Inc, which has been struggling to improve sales of its anti-obesity drug Qsymia, is not guaranteed success even if U.S. health regulators modify the drug’s risk management plan, one of the company’s top shareholders said.

Under a Risk Evaluation and Mitigation Strategy (REMS), the U.S. Food and Drug Administration has allowed Vivus to sell Qsymia only through mail-order pharmacies so far, as the drug has the potential to cause birth defects.

The company has blamed the slow uptake of Qsymia, the first diet drug to hit the U.S. market in more than a decade, on the REMS plan and submitted a proposal to the FDA to modify this so the drug could be sold through retail pharmacies.

“(The REMS modification) is necessary but not sufficient for Qsymia’s success,” said Vivus shareholder First Manhattan Company (FMC), which last month said it planned to nominate six directors to Vivus’ board at the company’s 2013 annual meeting.

FMC, which owns about 9.1 percent Vivus stock, has argued that the Vivus board needs to be more independent and have greater experience in guiding a company with a potential blockbuster drug.

On Wednesday, FMC agreed an expected REMS modification would be “a step forward,” but said achieving the drug’s full potential would require a new commercial strategy, including finding a partner to help market Qsymia.

A Vivus spokesman declined to comment.

Vivus shares, which have shed about half their value over the past six months, were up about a percent at $10.92 in morning trade on the Nasdaq.

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