Vivus Inc. (VVUS) received a major boost when the U.S. Food and Drug Administration (FDA) approved its erectile dysfunction (ED) drug, Stendra (avanafil). The company is also seeking to get the drug approved in the European Union (E.U.) and has made a regulatory filing for the same.
Vivus is currently looking for potential partners for the worldwide commercialization of Stendra.
Vivus in-licensed the worldwide (except certain Asia-Pacific countries) development and commercialization rights to Stendra from Mitsubishi Pharma Corporation. The drug is marketed in South Korea by JW Pharmaceutical under the brand name Zepeed.
The clearance of Stendra makes it the first FDA approved product at Vivus. Last month, the FDA extended Vivus’ obesity candidate, Qnexa’s, target date to July 17, 2012 from April 17, 2012.
Vivus had submitted the Risk Evaluation and Mitigation Strategy (REMS) for Qnexa in the first week of April. The REMS is a major amendment to the new drug application (NDA) and consisted of proposed REMS materials. Since Vivus made the submission within three months of the target date, the FDA had to extend the Prescription Drug User Free Action (PDUFA) date in order to review the submission.
The company is looking to get Qnexa approved for the treatment of obesity, including weight loss and weight maintenance for obese patients (BMI > 30 kg/m2), or overweight patients (BMI > 27 kg/m2), with weight-related co-morbidities such as hypertension, type II diabetes, dyslipidemia, or central adiposity (abdominal obesity).
Neutral on Vivus
We currently have a Neutral recommendation on Vivus. The stock carries a Zacks #3 Rank (Hold rating) in the short run. We expect investor focus to remain on Qnexa’s approval.
VIVUS INC (VVUS): Free Stock Analysis Report
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