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The Stendra application is based on a Phase III programme which included over 1,350 patients
Data showed that Stendra (Avanafil), which is licensed from Japan's Mitsubishi Tanabe Pharma Corp, was well tolerated and effective in treating men with erectile dysfunction.
All Stendra doses tested – 50mg, 100mg and 200mg – met each of the co-primary efficacy endpoints of the studies, Vivus notes, with the 200mg dosage performing well in terms of erections sufficient for penetration and successful intercourse. Across all the Phase III studies, success in the latter was observed in some avanafil-treated patients as early as 15 minutes after dosing.
Leland Wilson, Vivus chief executive, noted that Stendra was well tolerated and had a low dropout rate in all of the trials. If approved, "avanafil could be an attractive treatment alternative for the 30 million men in the USA who suffer from ED", he added.
Mr Wilson concluded by saying that the unique profile of potentially faster onset and greater selectivity should allow Stendra, (Avanafil) to effectively compete in the $4 billion worldwide ED market". The latter is currently dominated by Pfizer's Viagra (sildenafil), followed by Eli Lilly's Cialis (tadalafil) and GlaxoSmithKline/Bayer's Levitra (vardenafil).
Vivus, which has been the subject of frenzied takeover talk since advisors to the US FDA backed its obesity drug Qnexa, has launched a public offering aimed at raising $202.5 million.
The firm is putting up 9 million shares priced $22.50 per share and the offering is expected to close on March 6. Vivus has also granted the underwriters an option to purchase up to nearly 1.4 nillion additional shares.
The proceeds will be primarily used to fund a sales force and the production of promotional materials necessary to commercialize Qnexa (phentermine/topiramate), which last month got the backing of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee. Cash will also be used to support non-US marketing approvals for Qnexa and Vivus' impotence drug avanafil.
Simos Simeonidis, an analyst at Cowen & Co, said the offering is a "prudent and conservative move for the company to take advantage of the substantial move in the stock to significantly strengthen the balance sheet". He added that should Qnexa be approved by April 17, "there will be an additional move to the stock, and we expect that the company could tap the capital markets again…in order to improve its negotiating position with big pharma partners/potential acquirers".
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