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VIVUS (VVUS) Updates on Qsymia Plans; Will Continue Talks with U.S., EU Regulators

March 30, 2015 4:07 PM EDT

VIVUS (NASDAQ: VVUS) announced an operational update, including certain key corporate decisions and plans regarding Qsymia (phentermine and topiramate extended-release) capsules CIV. These plans include further investments in high-value, consumer-focused digital media projects in support of obesity education and Qsymia, and focusing the Qsymia field sales organization of approximately 100 territories on the most productive target areas. Management will continue discussions with US and EU regulatory authorities regarding Qsymia development and potential cost-saving measures related to the planned cardiovascular outcomes trial (CVOT), and will aim to further improve corporate efficiency and control costs while maintaining and extending the value of avanafil.

"We are encouraged especially 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 H. Z. Fischer, CEO of VIVUS. "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 activities. We are currently refining our commercial footprint in order to maintain proper deployment against the most important healthcare providers and payors within the anti-obesity market. Digital media, including search engine optimization and other Web-based patient outreach, will continue to be enhanced and will remain a priority going forward. We are continuing to identify efficient ways to build awareness for Qsymia as the market develops for FDA-approved treatments for the disease of obesity."

VIVUS plans to discuss with U.S. regulatory authorities and key consultants potential cost-saving alternatives with respect to the Qsymia CVOT, known as AQCLAIM. The Company is also in the process of pursuing approval for Qsymia in the EU and other key countries, as well as new indications in other chronic diseases such as obstructive sleep apnea (OSA) and type 2 diabetes. VIVUS plans to optimize spending while pursuing these potential objectives.

"Our confidence in and commitment to our avanafil franchise remains unchanged," Mr. Fischer concluded. "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."



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