New impotence drug to be launched next year

A new impotence drug is set to be launched in the first half of next year after receiving backing from the European body responsible for drug approval, it was announced today.

The drug, called Levitra, was developed by Germany’s Bayer but is subject of a global co-marketing agreement between the group and GlaxoSmithKline.

The pair said today the drug had received a “positive opinion” from the European Committee for Proprietary Medicinal Products (CPMP).

Glaxo said this meant a European Marketing Authorisation should be granted within the next few months followed by a launch in Europe in the first half of 2003.

The drug is set to compete with Pfizer’s blockbuster drug Viagra, while another impotence treatment is also set to be launched by rival Eli Lilly, called Cialis.

Dr Wolfgang Plischke, president of Bayer Pharmaceuticals, said: “This positive opinion from the CPMP – received earlier than anticipated – marks another important milestone, bringing us one step closer to the global launch of Levitra.”

Glaxo said that an estimated 152 million men worldwide were affected by erectile dysfunction – the inability to sustain an erection sufficient for sexual intercourse – but only 10% were being treated.

The group said clinical data presented to the CPMP showed in a large-scale trial 85% of men taking 20mg of Levitra reported an improvement in erectile function, compared with 28% on placebo.

In its statement the CPMP said: “The benefits with Levitra are its effect on smooth muscle relaxation, inducing a rise in intracavernosal pressure and consequently penile erection.

“Levitra has no effect in the absence of sexual stimulation. The most common side affects are headache, flushing, nasal congestion, nausea, dizziness and dyspepsia.”

Shares in GSK were up 2% in early afternoon, up 3.75p at 221.25p.