Once daily Cialis comes up with the goods
European Commission granted approval for Eli Lilly’s once-a-day version of Cialis (tadalafil), its erectile dysfunction treatment drug, what give the company a head-start over other ED treatment possibilities which are taken on an as-needed basis.
The approval, gave to the public late yesterday, only confirm that company is going to the proper direction, from January acquisition of Icos for $2.3 billion (€1.7 billion). This gave Lilly exclusivity on the Cialis market and sales. Until January, Icos had partnered in a join venture developing and launching Cialis in 2003.
Committee for Medicinal Products for Human use (CHMP) in the UK gave positive opinion for the marketing authorization for 2.5mg and 5mg doses of Cialis.
Lilly expects to launch the new doses in select countries in the second half of 2007 and spreading through other EU countries in 2008. The advised starter dose is 5mg a day, however it could be reduced to the 2.5mg depending on individual tolerability.
The company is still waiting for the decision of the US Food and Drug Administration (FDA) if it gets approval for the once-a-day Cialis dose.
Cialis the most competitors is Pfizer’s Viagra, it generated worldwide sales of $1.7bn, however Lilly’s product is going after him. Despite that Viagra is more popular in U.S., Cialis has the No.1 place in Europe and it gives its developer annual income of $971m worldwide in 2006.
This new formulation will be a great add-on to the Cialis sales, which now is showing solid growth (up 19 percent each year).
Eli Lilly and Co. was not prepared to speak about sales projections on how well the new version of its product would do in the market, however company spokeswoman, Keri McGrath, told in PharmaTechnologict.com “there is a need for innovation in ED treatments because different patients have different needs”.
This new once-a-day version of Cialis allows man to have sex within a narrow time frame, like while using other products currently available on the market.
Abbas Hussain, president of Lilly’s European Operations said: “The approval of Cialis for once-a-day use marks the first time an oral ED prescription only medicine is available to provide some men with an everyday way to treat their ED”.
The company states that the new once-a-day version which was just approved in the Europe, is designed for men intending to have sex at least twice a week. The previous on-demand version of Lilly’s product at 10-mg and 20-mg doses have been available in the EU since 2002, however at a maximum recommended dose of one pill daily taken shortly before planed sexual activity.