Once daily Cialis comes up with the goods
treatment Cialis (tadalafil) has been granted approval by the
European Commission, giving it a head-start over other ED
treatments that are taken on an as-required basis.
The approval, announced late yesterday, nicely compliments the company's January acquisition of ICOS for $2.3bn (€1.7bn) which gave Lilly full control of the Cialis empire.
Up until January, the companies had partnered in a joint venture developing and launching Cialis in 2003.
Marketing authorisation for Cialis at 2.5mg and 5mg has been granted, following a positive opinion from the Committee for Medicinal Products for Human use (CHMP) in the UK back in April.
The company anticipates the launch of the new doses in select countries during the second half of 2007 and continuing throughout other EU countries during 2008.
The recommended dose is 5mg a day, but can be reduced to the 2.5mg level based on individual tolerability.
The firm, which submitted Cialis once-a-day for approval to the US Food and Drug Administration (FDA) at the end of 2006, is still waiting to hear how the drug will fear in the US.
Last year Cialis generated worldwide sales of $971m, and is one of the key competitors of Viagra (sildenafil citrate), Pfizer's blockbuster erectile dysfunction treatment that generated a hefty $1.7bn in 2006.
Despite first quarter sales of Cialis showing strong growth (up 19 per cent year on year), this new formulation will be a definite bonus feature in Lilly's portfolio.
While the company was not prepared to make sales projections on how well the new formulation would do in the market, Eli Lilly spokeswoman Keri McGrath told in-PharmaTechnologist.com "there is a need for innovation in ED treatments because different patients have different needs".
In contrast to other products currently on the market, the once-daily formulation eliminates the requirement to have sex within a narrow time frame.
"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," said Abbas Hussain, president of Lilly's European Operations.
According to the company, the once-daily version just approved across Europe is intended for men intending to have sex at least twice a week.
The earlier on-demand versions of Cialis at 20-mg and 10-mg doses have been available in the EU since 2002, but at a maximum recommended dose of one tablet per day taken shortly before anticipated sexual activity.
