VIVUS Clarifies Misstatements by First Manhattan
VIVUS, Inc. (NASDAQ: VVUS) (the "Company"), a pharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today clarified several misstatements made by First Manhattan Co. (FMC):
FMC's Misstatement: The launch of Qsymia was mismanaged.
The facts: When Qsymia® (phentermine and topiramate extended-release) capsules CIV was approved, it included a highly restrictive FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) which made the prescribing and dispensing process very cumbersome for healthcare providers, especially primary care physicians with busy practices. We believe FMC's negative characterization of the Qsymia launch blatantly disregards the significant barrier that the Qsymia REMS created for VIVUS. Qsymia's availability was limited to a small, closed network of certified mail-order pharmacies. In addition, healthcare providers were required to complete and fax prescription forms and pharmacies were required to confirm the information with patients by phone. These burdensome requirements created an average two-week time delay between physicians prescribing Qsymia and the actual delivery of the drug to patients, which significantly hindered new patient starts and refills. As a result of this restrictive mail order-only distribution system, efforts to drive patients to seek treatment with Qsymia were not feasible as