Bayer and GSK agree on vardenafil co-promotion
Bayer and GlaxoSmithKline (GSK) have signed a co-promotion agreement for vardenafil, Bayer's new erectile dysfunction (ED) treatment. Bayer will manufacture the product, be responsible for all regulatory work required to obtain product approval and will account for all sales. GSK and Bayer will share selling and future development expenses and both companies will share profits. The companies will form a joint steering committee to oversee marketing and future development of the product throughout the world, except in Japan.
Bayer submitted an application for approval of vardenafil for the treatment of ED to the FDA in September with a parallel submission in Mexico. The company also submitted vardenafil for review in Canada in October. An application for approval is expected to be submitted to the EU in December. Results of the FDA assessment are expected in the second half of 2002.
Bayer estimates global peak sales for vardenafil, a highly potent and selective phosphodiesterase-5 (PDE-5) inhibitor, to reach more than €1bn (US$879m) a year.