Cervical Cancer: Endangered Species - Pharmaceutical Executive


Cervical Cancer: Endangered Species
Preventive care is more efficient than treating disease after the fact. Now this paradigm takes hold in cancer.

Pharmaceutical Executive

Here, we share the tale of the two vaccines, Gardasil and Ceravix—particularly through the eyes of Barr and Dubin, who have painstakingly toiled for almost a decade over these vaccines. For those men, there is little time to sit and reflect on their accomplishments given the big implementation challenges that lie ahead. To that end, we also provide some analysis of the obstacles they face in ensuring the vaccines live up to their promise and potential.


Merck's Eliav Barr have followed the development of Ceravix and Gardasil, respectively, since those drugs were licensed into their companies.
Dr. Eliav Barr remembers the first confirmation that Gardasil was going to be a winner. "The first real 'a-ha' moment came in June 2001, when we [got the results of] a blinded interim analysis of a study that looked at the HPV-16 component of Gardasil," says Barr. Merck had decided to conduct a full-fledged efficacy study of this prototype vaccine. "The study was blinded, and only one person got to see the data," continues Barr. "But when he came out [from analyzing the study], he told us to go home and to enjoy a really good dinner and celebrate—and plan on moving the vaccine forward."

It wasn't until five months later that Merck unblinded the study results, and Barr could see the data. "It took my breath away," recalls Barr. "Vaccines tend to be much higher in terms of efficacy than drugs, but even there, there are very few vaccines that are 100 percent efficacious: Measles, mumps, rubella, and Merck's hepatitis A vaccine—but that's about it."

GSK's Gary Dubin shared a similar experience—a feeling of awe in light of the data. "No one thought a vaccine targeting cancer had the potential to be that highly effective," says Dubin. "Typically, improvements in cancer therapies tend to be small and incremental. Something that improves on an existing therapy by five or 10 percent is considered a big step forward. Of course, we had high hopes when we started, but in this case, we've seen numbers that go beyond what we had imagined."


Most media reports have boiled down the similarities and differences between Merck's and GSK's vaccines into simple terms. Gardasil and Ceravix both offer protection against the two HPV types that cause about 70 percent of cervical cancer, types 16 and 18. But while Gardasil also protects against HPV types 6 and 11, which cause genital warts, GSK's doesn't. Taken together, analysts forecast the market for HPV vaccines to reach $4 billion by 2010.

If things go as expected, Merck's Gardasil will be the first to market and, as such, will achieve some of the advantages associated with being a front-runner. In particular, the company is banking on the fact that physicians will achieve a level of familiarity with the vaccine, and will be unlikely to switch to Ceravix when it debuts. Merck will also capture the "catch-up" vaccination market—that is, HPV-negative women from 15-49 who decide they want to be vaccinated—for at least one year, says Datamonitor analyst Holger Rovini.

Pamela Rasmussen Digene
"After that, it will be down to who is better at communicating their marketing message and the perceived advantages of differentiating product attributes: duration of immunity, breadth of HPV-subtype coverage, side effects," says Rovini.


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