Levitra brings three dimensions to ED market
pharmafile | October 31, 2003 | News story | |Â Â Â
Bayer and GlaxoSmithKline's new erectile dysfunction treatment Levitra has been launched in the UK, its first market after receiving European marketing authorisation.
Bayer and GSK say Levitra is about "more than just achieving erection" and promise "three dimensional erections, ie, those are that hard enough, reliable and sufficiently long-lasting for successful sexual intercourse."
The drug is the third in the PDE-5 class of drugs pioneered by Pfizer's Viagra, and follows hot on the heels of Eli Lilly's competitor Cialis, launched in January.
Levitra has been priced at £19.34 for a pack of four 10 mg tablets or £23.50 for a pack of four 20 mg tablets, equal to the price of Viagra 50 mg and 100 mg respectively. Cialis costs £19.34 for a four-tablet pack regardless of the dose.
The rivals to Pfizer's distinctive blue diamond-shaped pill have been produced as a round orange tablet marked with the Bayer cross (Levitra) and a yellow almond-shaped tablet marked with C10 or C20 depending on the dose (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.
Bayer and GSK say that, in the test tube, Levitra has proved itself a more potent PDE-5 inhibitor than either Viagra or Cialis, but to date there have been no clinical trials to directly compare the three drugs.
Pfizer has, however, released data from a head-to-head trial with the only other significant player in ED drug treatment, Abbott's Uprima, an apomorphine product that stimulates erections via the brain. A 20-week cross-over trial involving 118 men found 75% of intercourse attempts were successful for Viagra patients, compared to 35% for men on Uprima.
But clinical trials of Levitra against a placebo showed it to work twice as quickly as Viagra, while Cialis has been shown to last more than four times as long as Pfizer's drug.
In response to Cialis' claims to work all day, Bayer and GSK say that Levitra's half-life of four to five hours allows patients to be confident that the drug is not circulating in the body for any longer than necessary.
The companies' marketing material quotes a medical specialist in erectile dysfunction as saying: "With existing therapies for ED, it is not uncommon for men to have to take the treatment five to six times before it will work for them."
Owen Collins, Head of Medical Sciences at Bayer, said: "We think Levitra is a real step forward, we have data which tells us that reliability rates for Levitra are 90% for most men, first time and time after time."
The two new products are still waiting for regulatory approval in the US, although Lilly received an FDA approvable letter for its drug last April and Levitra is expected to be approved in the second half of this year.
Pfizer is trying to stop the US launches of Cialis and Levitra on the grounds they infringe its patent to use oral PDE-5 inhibitors, which treat impotence by acting on a particular enzyme, but similar legal moves have already failed in Europe.
Levitra was discovered by Bayer and will be co-marketed with GSK on a world-wide basis. It is an important new drug for both GSK, which needs to rejuvenate its product pipeline, and Bayer, which needs to get its pharma business back on track.
Werner Wenning, Chairman of the Board of Management at Bayer, said: "This is an extremely important step for our pharmaceuticals business, as we believe that Levitra has the potential to become a new blockbuster."
The European Commission's decision to approve Levitra was based on clinical trials of more than 3,750 men, which showed the drug to work quickly with reliable efficacy over time.
It is estimated that only 10% of the 2.3 million men in the UK affected by impotence and that, despite Viagras success, around 30 million European men are affected by erectile dysfunction.
