Lilly rapped for Cialis' premature marketing

Eli Lilly has been publicly reprimanded for bringing the pharmaceutical industry into disrepute after promoting its erectile dysfunction treatment Cialis months ahead of receiving marketing authorisation.

The ABPI Board of Management meted out its sternest rebuke to the company after finding the company had breached the code that prohibits any promotion of products before they are granted a licence.

The offence came to light when Pfizer reported that Lilly sales representatives were 'detailing' urologists on the new faster acting rival to Viagra, Pfizer's current market leader.

The Prescription Medicines Code of Practice Authority found Lilly had begun detailing doctors in March 2002, a full 11 months before marketing clearance was granted. The board said it was extremely concerned about the scale of Lilly's activities, with 18 representatives promoting its drug in over 9,000 visits to relevant health professionals.

Pfizer reported the activity to the PMCPA in July 2002 with hearings, including an appeal by Lilly, concluding in February, and with the ABPI's censure just days after Cialis gained official marketing approval.

Lilly claimed that its communications with doctors had been conducted in good faith, and that it believed its rep activity fell into an exemption from the Code that permits companies to talk about conditions as long as no direct or indirect reference is made to specific medicines.

This was, however, rejected by the board, which found the company in breach of the code on a number of points. It found that reps had introduced the new partnership of Lilly/Icos a co-marketing agreement based solely on Cialis, and thus indirectly promoting the treatment. Moreover, the sales aid referred to Viagra and its perceived shortcomings, criticism that qualifies as promotional under the Code.

The appeal board said Lilly's activities amounted to a 'softening up' exercise designed to heighten awareness of the Lilly/Icos partnership and to raise expectations that Lilly/Icos would market a product to meet perceived constraints of currently available medicines.

The case has highlighted the intense competitiveness of the UK's ED market, with Bayer and GlaxoSmithKline's co-marketed product Levitra becoming the third major competitor to join the fray in March, just weeks after Cialis.

Healthcare analysts ISIS Research says Lilly has already had a significant impact on Viagra's dominance its market share of 'opportunity' (ie, non-repeat) prescriptions falling from around 85% to just over 55% since Cialis was launched. Another product, Abbott's Uprima, was launched in 2001 but has had very little impact on Viagra's lead.

Amy Ridler, Healthcare Intelligence Systems Researcher at Isis, said it is still too early to tell if Cialis can overtake Viagra, but says Levitra has suffered from being the fourth ED product to market.

"Obviously, it is still early days for both products, but it seems that being fourth to market instead of third has been a disadvantage for Levitra so far. It is going to be interesting watching these new products over the coming months to see how much they can impact on Viagra's dominance in this market, and whether they too can become one of the few prescription drugs to have household name status".