Analysis: Will Gardasil nod boost rival?

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WASHINGTON, May 22 (UPI) -- Last week's recommendation from a Food and Drug Administration advisory panel that Merck's cervical cancer vaccine Gardasil should be approved may also be a win for GlaxoSmithKline's competing vaccine Cervarix.

"I think it's positive on many levels," Seymour Pierce analyst Sav Neophytou told United Press International.

"It means the FDA has gained experience looking at this kind of vaccine ... and will enable them to look at the Glaxo dossier in a more expedited manner," Neophytou added. It could also enable FDA to look at Glaxo's phase 3 trials before they finish.

He noted that the data on Cervarix "provides a compelling profile."

The FDA's Vaccine and Related Biological Products Advisory Committee last week unanimously recommended Gardasil be approved for use in females between the ages of 9 to 26. The FDA is not bound by the recommendations of its advisory committees, but the agency generally follows their advice. The FDA should issue a final decision by June 8.

Both Gardasil and Cervarix prevent infection with strains of human papilloma virus that cause about 70 percent of all cases of cervical cancer.

Navid Malik, an analyst with Collins Stewart, told UPI that Glaxo's vaccine may ultimately trump Merck's by a couple of billion dollars in sales.

"The forecasts for Merck's vaccine are too high at $2-4 billion and the consensus forecasts for Glaxo's vaccine are too low," Malik said.

Malik raised his forecast for Cervarix from $4 billion to $5.5 billion due to FDA comments released last week about Merck's Gardasil.

The comments by an FDA medical reviewer "highlighted a couple of issues that are advantages for GSK's vaccine and disadvantages for Merck's product," Malik said.

This includes that the "immune response for Merck's vaccine declines over time," he said. "The risk is you can have the emergence of the virus over time." In particular, "the antibody to HPV type 18 seems to be diminishing after 3 or 4 years," which is important because this subtype together with 16 are the cause of the majority of cervical cancers, he said.

Cervarix, on the other hand, seems to offer longer lasting protection that may persist for 15 years.

"Cervarix's immune response is very strong even five years out ... and Glaxo has said it has the potential to be a one-off jab over 15 years," Malik said. If that holds true, "there's no way a competitor product that requires boosters could ever compete," he said. Gardasil is administered in 3 shots over 6 months.

Still, both vaccines will rake in a few billion dollars in sales. "But Glaxo sales will be much more momentum-based," Malik said.

"I really do think Glaxo will play very strongly to these points of differentiation," he said, noting that he talked with company officials and "could sense the joy in their tone now that they know there are points of differentiation they can argue against."

Another advantage for Cervarix is that combining it with an adjuvant might enable the use of less vaccine. "So it might even have a costs of goods advantage," Malik said.

One challenge Glaxo faces is that it has not yet filed a new drug application with FDA, so its vaccine will be second to market. But Malik said he didn't think that would hurt Cervarix given what he sees as its advantages over Gardasil. He also noted that there have been other latecomer products that have gone on to overcome those that were first to market, such as Pfizer's Lipitor, which beat Merck's Zocor.

Another advantage Glaxo has is that it is fast becoming a dominant force in the vaccine arena. In addition to Cervarix, the company is also developing a vaccine for the H5N1 strain of bird flu that looks very promising, Malik said.

"If I was playing this market, I wouldn't invest in any other vaccine player today except Glaxo," Malik said. Referring to Roche as the "king of antibodies," he said, "Glaxo is going to become the Roche of vaccines."

John Lebbos, an analyst with Decision Resources, told UPI Merck's Gardasil may have an edge in that it also prevents infection with strain of the human papilloma virus that cause genital warts.

"That could be a clear advantage, but beyond that, it's not clear there's any efficacy advantage between the two vaccines," Lebbos said.