New ED therapies will expand market

Published: 22-Aug-2002
Regulatory


New oral therapies for erectile dysfunction (ED) will help to drive market growth, according to a new report from research consultancy Decision Resources. Sales in the seven major pharmaceutical markets (US, France, Germany, Spain, Italy, UK and Japan) are likely to reach US$2.6bn (€2.7bn) in 2006, rising to $3.6bn (€3.7bn) by 2011.

'There are two major drivers for the ED market; first, new therapies are expected to produce faster onset of action, longer duration of action and fewer side effects,' said Kat Neumeyer, analyst at Decision Resources. 'These improved therapies will provide the second market driver - an increasing drug-treated population - by giving patients more alternatives when first-line oral agents are ineffective.'

Pfizer's blockbuster drug Viagra will face major competition from new oral phosphodiesterase inhibitors such as tadalafil (Eli Lilly/ICOS's Cialis) and vardenafil (Bayer/GSK's Nuviva), says the report, entitled Erectile Dysfunction. The 1998 market debut of Pfizer's Viagra (sildenafil) revolutionised the management of ED and quickly established itself as a blockbuster drug. In 2001, the ED market in the seven major pharmaceutical markets continued to be dominated by Viagra, which claimed 93% of the $1.3bn (€1.3bn) sales.

Bayer and GlaxoSmithKline recently received an approvable letter from the FDA for vardenafil. The drug has been approved in several Latin American countries and has been submitted for approval to regulatory agencies in all major markets.

The companies said that the FDA has asked for additional clinical pharmacology studies before granting final approval for vardenafil. A US launch for the product is now projected for 2003.

Dr Wolfgang Plischke, president, pharmaceutical division of Bayer HealthCare, said, 'Bayer and GSK are committed to bringing vardenafil to market as quickly as possible, and believe that the compound can provide a new alternative for millions of men.'

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