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Levitra becomes Viagra's first US challenger

Published on 29/10/03 at 09:34am

GlaxoSmithKline and Bayer's erectile dysfunction is to become Viagra's first major competitor in the US after receiving marketing approval.

Launched in 1997, Viagra became a household name overnight, transforming the lives of men with erectile dysfunction and earning billions for Pfizer.

The company has enjoyed a virtual monopoly in the market since then, but GlaxoSmithKline and Bayer hope to challenge Viagra dominance with Levitra.

The companies are promoting Levitra as having distinct advantages over Viagra "three dimensional" erections which are hard enough, reliable and sufficiently long-lasting for successful sexual intercourse.

In common with Viagra, men taking nitrate drugs for angina should not use Levitra, but, unlike Pfizer's drug, men taking Levitra can do so without regard to meals, potentially making it more convenient to use.

Levitra received FDA approval after the companies conducted more than 50 clinical trials in more than 5,700 men. Results from phase III clinical studies showed that Levitra helped men achieve and maintain an erection sufficient for satisfactory sexual performance and worked first time for many men.

Viagra will face a second competitor in the US by the end of the year if, as expected, the FDA grants Eli Lilly and Icos approval for their ED treatment Cialis.

Both Levitra and Cialis are predicted to have potential annual sales of around $1 billion. Last year Viagra generated $1.7 billion for Pfizer from an estimated potential patient population of around 30 million men in the US and 152 million men worldwide.

To promote the new drug to its target audience GSK and Bayer have hired former Chicago Bears coach Mike Ditka as a spokesman for a new men's health campaign in assocation with the American Football league the NFL.

This is the first time the NFL has signed such a deal with pharmaceutical companies and it gives GSK and Bayer exclusive sponsorship rights in the men health category in a three-year deal.

Colin Foster, president, Bayer Pharmaceuticals, said: "The men health education campaign will bring important information to men and their loved ones, with the overall goal of encouraging men to proactively manage their health and visit their doctor."

Although Levitra won't be mentioned in the ads, the companies hope men will feel comfortable enough to talk about impotence with their doctors if they can be persuaded to visit their surgeries.

By signing up sports stars to promote their product the companies are following in the footsteps of Pfizer who use Brazilian football legend Pele to front its ED awareness campaign as well as baseball player Rafael Palmeiro and racing driver Mark Martin. Meanwhile, Lilly and IcosCialis will be a major sponsor of the America Cup 2003.

Both drugs belong to the PDE-5 class of drugs pioneered by Pfizer's Viagra that act on a particular enzyme to treats impotence.

Pfizer last year filed a patent infringement suit against the manufacturers of Levitra and Cialis. According to GSK and Bayer, Pfizer's case is still in its early stages.

Pfizer is aiming to block the sale in the US of both Levitra and Cialis on the grounds that they contravene its US patent for oral PDE-5 inhibitors, which it says is valid until 2019.

Cialis was launched in Europe in January, two months before Levitra came to the market. Healthcare research company Isis Research say Levitra had not yet managed to match Cialis' early success in the UK in capturing new ED prescriptions.

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