April 3, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Mountain View, Calif.-based VIVUS, Inc. announced yesterday that it was cutting its U.S. sales force from 150 to 100.
The company focuses on weight loss drugs and “innovative, next-generation therapies to address unmet needs in obesity, diabetes, sleep apnea and sexual health.” In the U.S. it markets Qsymia, for weight management, and Stendra (avanafil), for the treatment of erectile dysfunction.
In addition to the layoffs, the company indicated in a statement that it was going to shift some of its focus to “high-value, consumer-focused digital media projects.” This sounds like mobile apps, with the intended focus being obesity education.
“We are encouraged specially by the success of our Qsymia digital marketing initiatives, which are providing motivated consumers the new information they need to start a conversation with their healthcare providers about weight loss and Qsymia,” said Seth Fischer, chief executive officer of Vivus in a statement. “This trend is seen also in the increasing number of new Qsymia prescribers, many of whom have not been targeted by our medical education or commercial sales activity.”
On March 30, 2015, the company announced it was updating its corporate decisions and plans regarding Qsymia. In addition to the job cuts and the digital media, the company plans to work with the U.S. and European Union regulatory authorities regarding possible cost-saving measures related to the company’s planned cardiovascular outcomes trial (CVOT).
Analysts are skeptical about why regulators would consider changing an approach mid-study in a cardiovascular outcomes trial. There is some concern that it would set a precedent for other companies to tinker with study structure mid-stream.
“We find it unlikely that either agency would allow the company to not stick to the original plan of conducting [the trial] as agreed [with FDA] or to apply for approval without the interim data [as the EMA did],” said Simoso Simeonidis, analyst with RBC Capital Markets in an investor note. “We believe that the company’s rationale that the drug has already been on the market for two-plus years without any safety issues will have a hard time gaining significant traction.”
Vivus is also in the process of applying for approval in the EU and other countries for approval for Qsymia, as well as for other indications, such as obstructive sleep apnea (OSA) and type 2 diabetes.
In terms of the Stendra markets, the company seems content with its current path. “Our confidence in and commitment to our avanafil franchise remains unchanged,” said Fischer in a statement. “We will continue to work closely with our worldwide commercial alliance partners in the erectile dysfunction market as part of our effort to ensure that we maximize the potential value of this important asset. Our avanafil license with Mitsubishi Tanabe Pharma Corporation includes development and commercialization rights in all human indications, and we plan to conduct a proof-of-concept study with avanafil as a treatment for pulmonary arterial hypertension.”
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
