1st Non-US Approval For VIVUS' MUSE

VIVUS and marketing partner Astra have been granted approval in the UKfor MUSE, their intraurethrally-delivered alprostadil product for the treatment of erectile dysfunction or impotence. This is the second approval for MUSE outside the USA where it was launched in January 1997. It starts the mutual recognition process for approvals throughout the European Union. A launch in the UK is scheduled for January, but Astra has not yet set pricing.

Chief financial officer of VIVUS, David Yntema, told the Marketletter that sales for the product in the first three quarters of 1997 were already topping $100 million in the USA, where it carries an average wholesale price of $17 per applicator. MUSE targets (and will likely broaden) the moderate-to-severe end of the market, currently addressed by penile injection products. He estimates a target population of 50 million men in developed markets.

Oral therapies, headed by Pfizer's Viagra (sildenafil) and Zonagen/Schering-Plough's Vasomax (phentolamine), address a more wide-ranging population and are likely to be used most often at the milder end of the disease spectrum; a target market of 150 million men worldwide. They are unlikely to rival the efficacy of MUSE and injectables at the severe end of the market.