) 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 (
). The company has also filed for the approval of avanafil in the
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 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
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 (
) with the European Medicines Agency (EMA) for Qnexa in December
2010. The Committee for Medicinal Products for Human Use (
) 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
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.
VIVUS INC (
): Free Stock Analysis Report
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