A Vaccine Gives Marketing Lessons

Beverly Lybrand, Vice President of the HPV Franchise and Gardasil at Merck, explains why the human papillomavirus (HPV) preventative vaccine Gardasil is still picking up steam.

Gardasil entered the pharmaceutical market with a bang – and it wasn’t just because it was introduced as the world’s first cervical cancer vaccine or because of its controversial nature. It was because the market was ready for it.

Aside from the heated social controversy – some praise it as a wonder drug while others claim it crosses moral and ethical boundaries – and the $127 million poured into marketing in the first half of 2007 alone, all the buzz and success can be boiled down to two very basic marketing components: education and awareness.

Since the vaccine’s US FDA approval in June 2006, more than 10 million doses of Gardasil have been distributed and it’s been approved in 86 countries.

It’s a success story that didn’t happen overnight. Work with Gardasil began over three years ago, resting on data from a decade-long, 27,000 patient study that proved 100 percent efficacy for human papillomavirus (HPV) types 6, 11, 16 and 18.

The prevalence of HPV, the sexually transmitted virus Gardasil is designed to defeat, is quite astonishing. Approximately 20 million people in the US are currently infected with HPV and approximately 80 percent of females will have acquired HPV by the age 50.

Depending on the HPV type, the virus may clear on its own. But certain low-risk types can produce abnormal Pap results and cause genital warts, while other certain high-risk types can lead to cervical cancer. Gardasil was approved for the prevention of cervical cancer; cervical, vulvar and vaginal pre-cancers; low-grade cervical lesions; and genital warts caused by HPV types 6, 11, 16 and 18 for girls and women age nine to 26.

While Gardasil accounts for just four of the over 200 types of HPV, two of those – HPV types 16 and 18 – have been cited to be responsible for 70 percent of cervical cancer cases. This important link came with another startling fact: studies by Merck found that less than five percent of the US female population was aware of this link.

This little known fact thus became the fulcrum of the campaign and the basis for the decision to market the vaccine as a cancer vaccine. With extremely high prevalence of HPV against the backdrop of extremely low awareness between its link to cervical cancer, the stage was set for Beverly Lybrand, Vice President of the HPV Franchise and Gardasil, and her team at Merck to saturate the market with awareness messaging and pave the way for Gardasil’s entrance.

Priming the market
The blatant and alarming gap in awareness was thus an opportunity and a challenge for the campaign to take hold. It required getting the message out early to the right audiences – and Lybrand did just that, hitting exactly the right chords with physicians, mothers and young women.

Lybrand’s masterfully executed marketing campaign that hit on all the right pressure points at the right time, offers a prime lesson on audience analysis. “How you start in the early phase is to really understand what the various constituents and stakeholders think and know, and then you can establish a baseline and begin to develop approaches, programs and educational materials that will help set the stage,” Lybrand explains.

Clinical studies were still ongoing when the Gardasil Team began to reach out to understand physician and consumer perspectives, particularly mothers of young women and young women themselves, and what they understood about HPV disease and its link to cervical cancer.

After discovering the tremendously low awareness, communicating the link between HPV and cervical cancer became the primary focus of the campaign. It required tailoring the message to each particular audience: for physicians, the focus was obviously the medical impact along with physicians’ role in helping patients become better informed; for mothers, it was the emotional call to protect their daughters; and for young women, it was the notion of empowerment from taking control of their own health.

One of the biggest threads the campaign played on was mothers’ concerns around their daughters’ protection, touching on cancer fears and the strong emotional engagement between mothers and their children. “Tapping into that notion that moms want to do everything that they can to protect their daughters is a fundamental insight, and a decision that we made to base our messaging and creative around,” Lybrand admits.

Timing decisions also played a crucial part in the brand’s success. In fact, Merck launched two full-blown campaigns before Gardasil even entered the market: ‘Tell Someone’ and ‘Make the Connection’ campaigns, which both used novel approaches to spread awareness. The ‘Tell Someone’ television campaign consisted of testimonial-style footage of confident, expressive females relaying their concerns and decisions in the context of HPV and cervical cancer statistics, staying true to the message of female empowerment through awareness and action.

“One thing that’s really unique about the ‘Tell Someone’ campaign is the insight from the individual women,” Lybrand acknowledges. “They would be faced with the facts and light bulbs would come on over their heads. It was this insight that this was so fundamental that ‘I should know this and share this with other women that I care about’, which served as the basis for the creative for the campaign.” As part of the campaign, Merck also produced accompanying printed educational materials for physicians to use when speaking to their patients about HPV, including the various types and their consequences.

The ‘Make the Connection’ campaign also stepped outside of traditional drug marketing by using beaded bracelets as a metaphor for the ‘bringing together’ of females around this important health topic. The actual bringing together of individuals included physicians sharing medical information and females sharing their own diagnosis stories, whether it was with HPV or cervical cancer. The physical activity of beading also served as an important means to bring people together and the bracelet itself could be worn to demonstrate support. The campaign saw a great deal of responsiveness – over 1.5 million bead kits have been distributed over the Internet since the campaign’s inception.

Gardasil’s big entrance
By the time Gardasil came off the FDA’s approval desk in June of 2006 for use in the US, the next call to action was to deliver to the market the magnitude of the clinical data findings from the rigorous worldwide clinical research study.

“We did our clinical research program in over 33 countries around the world and our clinical data was stunning in terms of its efficacy,” Lybrand says. “We then began to frame the data and understand how our customers and so forth would think about the data. The understanding at the individual customer level is really a hallmark of what we do.”

The ‘One Less’ campaign was launched, now tying in the Gardasil name, with the messaging hinged on the phrase, implying girls and women have the opportunity to choose to be one less victim of HPV and cervical cancer.

The positive and widespread reception of the vaccine didn’t come without a little opposition. Being the first vaccine to protect women against HPV, a highly common sexually transmitted disease, and being approved for females age nine to 26, set a delicate platform for Merck’s push to mandate the vaccine for middle school girls.

Parents and religious groups alike have expressed concerns that it might signal sexual activity is acceptable or protected to girls at an early age. Others are cautious to advocate the vaccine on the grounds that it might undermine safe sex or abstinence campaigns, since females can still contract STDs after receiving the vaccine, so there are worries that girls will stop regular screenings under the assumption that they’re now protected. But those behind Gardasil are well versed in the clinical data findings, and highly encourage girls and women to continue to adhere to safe health practices.

Lybrand points out that in all of its messaging, Merck stresses the need for regular screening, since 30 percent of cervical cancer cases fall outside the HPV cancer-causing types prevented by Gardasil. “We are very clear in our materials, whether it’s to physicians, individual women, mothers or consumers about the type-specific nature of the findings as well as the importance of screening and continued screening, even in the context of the vaccine. That’s a fundamental aspect and it’s very important.”

Amid so many divergent facets of and reactions to the vaccine, Lybrand arrives at what matters most: its indisputable and widespread health impact. “We have a vaccine that has exceptional efficacy; it has duration in terms of the data that we’ve proven and an ability to demonstrate that the immune memory is lucid,” Lybrand ascertains. “The women who benefit from this vaccine are ultimately the most important audience. Knowing that girls and young women are now potentially protected from disease and cancer, that’s been the primary focus and the greatest success.”

Extending Gardasil’s reach
Buoyed by its success with Gardasil among a few other big-hitters, Merck recently reported double-digit revenue and earnings-per-share growth for the third quarter of 2007. Sales of Gardasil increased 17 percent from the previous quarter and are only expected to grow, with Merck reporting that as of the third quarter, Gardasil has posted total sales of $418 million.

Gardasil has now been approved in 86 countries, with launches underway in 72 and the vaccine in review in approximately 50 other countries and territories. Not only is Merck pushing for the vaccine’s geographic spread but it’s also pushing for extended approval of the vaccine across different indications and demographics, including women over the age of 26 and men.

Merck initiated a study to understand the potential benefit that Gardasil may have on adult women through the age of 45; the data of which was recently presented at an international papillomavirus conference. Data from the investigational study is expected to be submitted to the FDA by the end of the year to seek an indication. In addition, there is an ongoing study in males to understand how Gardasil’s health benefits may transfer to the opposite sex, the data of which will also eventually be filed for approval for an indication.

New cross protection data was recently presented that measured the efficacy of Gardasil on cervical disease caused by ten additional HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58 and 59). The ten additional HPV types are responsible for more than 20 percent of cervical cancer cases worldwide.

The cross protection data has already been submitted to the FDA in addition to data submitted for extended approval of Gardasil to help prevent vaginal and vulvar cancers under a standard review period. Yet even amid her excitement around the broadened applicability of the vaccine in the works, Lybrand is quick to point out there’s still a lot of work to do on the path to eradicating the disease altogether.

Meanwhile, Merck has hit the jackpot with Gardasil. The three-dose intramuscular vaccine, to be administered in three separate injections in the upper arm or upper anterior thigh over a six-month period, costs a pricey $360 – and if school mandates go through, Merck will have a money cushion for some time to come. The dollar sign there has not surprisingly caught the glint in Wall Street’s eyes, as analysts predicted sales of Gardasil alone to be between $1 billion and $3 billion by 2010.

As one of the most successful product launches in recent pharma history and with already explosive sales, the vaccine is likely to reach blockbuster status. But soon it will have a competitor at its side trying to get a piece of the action.

Already available in Europe, GSK’s HPV vaccine Cervarix is close on Gardasil’s heels. Expected to enter the US market in late 2007 or the beginning of 2008, GSK hopes to capture half of the market. In spite of the threat of competition, Merck is going to stick with its guns and do what it’s been doing, which obviously has worked well for them. “The campaign you see now is pretty much representative of what we think is the right thing to do,” Lybrand says. “There’s been very broad uptake and just tremendous acceptance by women around the world. We still have a long way to go to eradicate this disease, so that’s really the focus and a great measure of our success.”

As General Manager for Gardasil, Beverly J. Lybrand, answers directly to the CEO, Richard T. Clark, and directs the global commercialization strategies and P&L for Gardasil, the world’s first cervical cancer vaccine. As Vice President, HPV Franchise, Gardasil, Global Vaccines & Infectious Diseases, Merck & Co., Lybrand directs strategic global franchise planning for HPV vaccine. She reports to the President of Global Vaccines & Infectious Diseases, Margie McGlynn.