Vivus (VVUS) has submitted an amendment to its REMS (Risk Evaluation and Mitigation Strategy) requirement to the FDA for consideration. If approved it would make the anti-obesity drug Qsymia more widely available to consumers.
When the FDA approved Qsymia back in July of this year there was a requirement that the company have a Risk Evaluation and Mitigation Strategy in place. Part of that strategy included the requirement the Qsymia prescriptions only be filled by qualified mail order pharmacies. One such pharmacy is Express Scripts (ESRX), which Vivus cut a deal with last week. Other requirements include a Medication Guide, healthcare provider training, patient brochure and education tools. The company states that these same materials and tools could be made available at pharmacies.
While there are advantages to having a drug that is free of REMS requirements, they are not ultra-restrictive. However, the more widely available that a company can make its drug, the better. The Vivus request for an amendment to the REMS strategy in place is a natural progression, and is actually a bit bullish.
Qsymia was launched in mid-September and thus far has only about a month of sales under its belt, but that has not stopped the company from landing a distribution deal and further trying to broaden the availability of Qsymia. I view these actions as positive.
Vivus is recovering from a dip on news that the company did not anticipate European approval of Qsymia. The market is eager to see some results from early sales of Qsymia. If the sales of this drug are tracking well, the Vivus equity has a decent shot at some upside. Perhaps 10% or more is not out of the question in the near term.