Merck & Co. Inc. caused a furor in the U.S. when it launched its Gardasil human papillomavirus vaccine in 2006, both among groups that viewed Gardasil as an STD vaccine that would encourage promiscuity, and as a result of the company's lobbying to make vaccination with Gardasil mandatory. In Europe, marketing partner Sanofi Pasteur MSD says it has learned from Merck's mistakes and is rolling out a less aggressive marketing plan.
In addition, as it prepares to face competition from GlaxoSmithKline plc's Cervarix vaccine, Sanofi Pasteur MSD is leveraging Gardasil's effectiveness against genital warts and more early cervical lesions as a way for payers to see short-term value in addition to the long-term value of protection from cervical cancer. Gardasil is also indicated for the prevention of precancerous vulvar lesions and has recently been filed for an extended market authorization to include prevention of vulvar and vaginal cancers.
For its part, GlaxoSmithKline (LSE:GSK; GSK, London, U.K.) reckons Cervarix will enter a primed regulatory and cultural environment. But its focus is on cervical cancer alone, which it feels is an attractive option in light of the controversy over genital warts. GSK is willing to forgo the short-term value proposition offered by the genital warts solution for what it sees as a more comfortable moral position. It aims to avoid the mandatory vaccination quagmire altogether.
Gardasil is marketed to prevent cervical cancer in more than 85 countries and Cervarix is approved in Europe and Australia to prevent precancerous lesions and cervical cancer, and in registration in the U.S. and Japan for the indications. GSK expects a decision by FDA