Vivus' REMS Called Out by Top Shareholder
According to its top shareholder, the current risk management plan utilized for Vivus's drug Qsymia would not guarantee its success in the market. These were the remarks of shareholder First Manhattan Company.
In a statement, First Manhattan said, "(The REMS modification) is necessary but not sufficient for Qsymia's success."
The risk plan involves the Risk Evaluation and Mitigation Strategy, a system that only allows the drug to be sold through mail-order pharmacies because of the inherent risk of the drug to cause birth defects. If revised under the proposals provided, the drug, which also doubles as the first diet pill to be introduced to the US market in more than ten years, can then be sold through retail pharmacies and over the counter stores.
The current plan by Vivus is well supported in the industry and even other shareholders. Amongst them is Chilton Investment Co, who said that the potential fo the drug still is to be demonstrated, thus the measured approach is just proper.