New Drug to Improve Erectile Function
Bayer and GlaxoSmithKline Announce EMEA Acceptance of Regulatory Filing for Vardenafil
Leverkusen/London ? Bayer AG and GlaxoSmithKline plc (GSK) today announce that the European Medicinal Evaluation Agency (EMEA) has accepted the filing of a the marketing authorization application for vardenafil for the treatment of erectile dysfunction (ED). Bayer submitted the registration dossier for vardenafil to the EMEA on December 28, 2001. Results of the assessment from the EMEA are expected in the first half of 2003.
The product has now been submitted for market approval in all major regions worldwide. Bayer filed dossiers to the registration authorities in the United States and Japan in September and December 2001 respectively.
In November 2001, Bayer AG and GSK signed a worldwide co-promotion agreement for vardenafil. The companies have formed a Joint Steering Committee to oversee marketing and future development of the product. Bayer estimates peak global sales for vardenafil of over EUR 1 billion a year.
Vardenafil, researched and developed by Bayer, is a potent and highly selective phosphodiesterase-5 (PDE-5) inhibitor. Its clinical development programme to date has included eight phase III trials involving approximately 4,000 patients. In a published pivotal phase III study, vardenafil produced statistically significant improvements in erectile function versus placebo with reported efficacy in up to 85 percent of the broad population treated.
It is estimated that ED ? the reduced ability to attain and, or maintain an erection sufficient for sexual intercourse ? affects more than half of all men aged over 40 years. While it is estimated that 140 million men worldwide are affected by ED, only one in 20 receives medical treatment, thus demonstrating the clear need for additional therapies in this area.
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