Vivus Inc. (VVUS) is keeping its fingers crossed with the target date (April 29, 2012) for one of its lead pipeline candidates, avanafil, fast approaching. Vivus is looking to get the candidate approved for the treatment of erectile dysfunction (ED). The company has also filed for the approval of avanafil in the EU.
Vivus has a development, licensing and supply agreement with Mitsubishi Pharma Corporation for avanafil. Mitsubishi Pharma is eligible to receive milestone payments on the regulatory filing, approval and sale of the drug in the US and the EU.
We note that the company is banking heavily on the approval of avanafil, as currently it does not market any drug. Moreover, earlier this month, the US Food and Drug Administration (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).
In February this year, the FDA’s advisory committee had voted 20-2 for the approval of Qnexa on the basis of a favorable benefit-risk profile of the candidate.
We would like to remind investors that Vivus had also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Qnexa in December 2010. The Committee for Medicinal Products for Human Use (CHMP) issued a 180-Day letter of intent (LOI) requesting additional information including risk minimization activities (the equivalent of REMS in the US) to address various issues relating to cardiovascular, neuropsychiatric and potential teratogenic effects of Qnexa.
Moreover, the letter requires Vivus to discuss the benefit/risk profile of the different doses of Qnexa, the drug’s potential use in different patient populations, and the expected long-term benefits of treatment with Qnexa. The company plans to respond to the letter in the second quarter of 2012.
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 avanafil and Qnexa’s approval.
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