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Product Team Cialis: Getting Ready to Market
It was early 2002, and Mark Barbato, the executive director and global product team leader for Cialis, knew he faced a daunting task: launching a medicine for the treatment of male impotence in a market with an established leader-Viagra. 1 Not only had Viagra been generating over $1 billion in sales annually for its parent company Pfizer for three consecutive years, but it also enjoyed the highest brand recognition of any other pharmaceutical drug in the world.
Despite the huge success of Viagra, Barbato and his team were very optimistic about the future prospects for Ciatis (active ingredient is tadalafii). The innovative new drug, developed through a joint venture (Lilly ICOS LLC) between Eli Lilly, the pharmaceutical giant, and rcos, a young biotech upstart, showed promising clinical results. At an upcoming prestigious urology conference, to be held in the spring of 2002, medical investigators would present data showing that a 20mg oral dose of Cialis improved the ability of up to 81 % of men suffering from male impotence to respond to sexual stimulation over an extended period of time, even 36 hours after taking the drug. Since Viagra's effect lasts approximately four hours after dOSing, the new treatment offered such men a significantly greater window of opportunity to choose the right moment of intimacy. Furthermore, the body's ability to absorb Viagra was diminished when the drug was taken during or after a high-fat meal, potentially leading to slower onset time 2 In contrast, the absorption of Cialis was not affected by food intake. Cialis demonstrated a generally favorable safety profile, similar to that seen with Viagra. Both drugs were not to be taken in conjunction with nitrates, which may be given to treat select heart problems. The incidence of visual irregularities, a side effect of Viagra, was notably rare for Cialis 3 Following Cialis's successful phase III clinical trials, a new-drug application (NDA) was submitted to the U.s. Food and Drug Administration (FDA) on June 28, 2001, and a similar application was filed in July with the European Agency for the Evaluation of Medicinal Products. With the approval process taking an average 12-18 months in both jurisdictions, the Lilly rcos LLC board members, comprising both Lilly and lCOS top management, were hoping for a launch in 2002. In preparation for the launch, a brand council was scheduled for January 18. The brand council would bring together top Lilly marketing representatives from around the world, all eager to learn how Cialis would be differentiated from the competition and how they should promote the new drug once it was approved. With the meeting less than two weeks away, the global marketing director for the Cialis product team, Rob Brown (from Lilly), and Leonard Blum, vice president of sales and marketing at ICOS, had their work cut out for them. They had to come up with a strategy that would guide all
1 Cia lis is a trademark of Lilly
reos LLC. Viagra is a trademark of Pfizer, Inc.
Lower peak bl.ood levels can a lso result. The regulatory guidelines used to determine the prese nce or absence of a food interaction (for package inserts/labels) are based on a very specifically defined hi g h-fat m ea l.
3 "Giving Viagra a Run For Tts Money," BusinessWeek, October 23, 2000.
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