Vivus, Inc. (VVUS) is highly dependent on Qsymia (proposed trade name: Qsiva in the EU) for its long-term growth. The drug was launched in the U.S. in Sep 2012. The U.S. Food and Drug Administration (:FDA) cleared Qsymia in Jul 2012 as an adjunct to a healthy diet (low on calories) and increased physical activity for chronic weight management in obese (Body Mass Index, or BMI - 30 or more) or overweight (BMI - 27 or more) adults suffering from at least one weight-related co-morbid condition.
However, Qsymia has performed disappointingly since launch. Qsymia revenues in the second quarter of 2013 were $5.5 million as compared to $4.1 million recorded in the first quarter of 2013.
The company is trying to boost revenues by gaining approval in Europe. VIVUS has submitted a request for scientific advice related to the use of interim data from the AQCLAIM cardiovascular outcomes trial to support the resubmission of the marketing application, to the European Medicines Agency. VIVUS expects to start patient enrolment for the study in the first quarter of 2014.
Apart from this, Qsymia has also received FDA approval for an amendment and modification to the Risk Evaluation and Mitigation Strategy (:REMS). As per the modification to the REMS, Qsymia can now be distributed through certified retail pharmacies apart from the existing certified mail-order pharmacy network. The company announced retail availability on Jul 1, 2013.
We remind investors that apart from Qsymia, another weight-loss drug, Arena Pharmaceuticals, Inc.’s (ARNA) Belviq, received approval in the U.S. last year. Belviq was launched in the U.S. in Jun 2013. Orexigen Therapeutics, Inc. (OREX) is also developing a candidate, Contrave, targeting the lucrative obesity market.
Apart from Qsymia, VIVUS’ portfolio consists of another approved product, Stendra, for erectile dysfunction (ED). The drug is approved in the U.S. (Apr 2012) and the EU (Jun 2013).
VIVUS, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma companies that currently look attractive include Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #2 (Buy).