Merck pressing for OK to market Gardasil for males

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Bottom line:>>"As we look to the additional populations, we recognize the challenge is greater and the peak vaccination rates are likely to be lower than they will ultimately be for the adolescent female population," Frazier said. "We are, however, focused on continuing to drive revenue with Gardasil."<<=========http://snipurl.com/a22rrMerck pressing for OK to market Gardasil for malesMonday, January 12, 2009BY SUSAN TODDStar-Ledger StaffAfter more than two years of selling the Gardasil vaccine as a way of protecting girls and young women against cervical cancer, Merck is asking federal drug regulators to allow the vaccine's use in boys and men between the ages of 9 and 26.The drugmaker is counting on the expanded use to boost sales of Gardasil, which have flattened after a quick start. Getting that boost, however, may prove difficult.After two years on the market, Gardasil's side effects have made some pediatricians more reluctant to recommend it for their youngest patients. And despite the vaccine's early, soaring revenue -- it reached sales of $1.4 billion in its first year -- Merck has yet to capture a huge share of its primary market: young women, including college students.The vaccine could be an even harder sell for boys.One of the big reasons to vaccinate males is to stop the spread of the human papillomavirus, a sexually transmitted disease often referred to simply as HPV. But that may not prove as compelling a sales pitch as one that touts a vaccine as a protection against cancer."Boys don't get cervical cancer," said C. Anthony Butler, an analyst with Barclays Capital in New York City, "so parents could be reluctant to provide them with the vaccine."We want better health, but we don't want to do what's required to get it," Butler said. "It's a Catch-22."Merck submitted an application to federal drug regulators last month requesting approval to begin selling Gardasil to boys as a protection against HPV-caused genital lesions. The U.S. Food and Drug Administration is expected to decide later this year whether Merck's application meets its standards.Gardasil was originally approved by the FDA in 2006 as a vaccine to protect girls and young women against four strains of HPV -- known as 6, 11, 16 and 18. Health officials have blamed the latter two strains for causing an estimated 10,000 new cases of cervical cancer each year.Yet from the beginning, the vaccine proved to be controversial, partly because of the sexual nature of the virus and partly because of Merck's focus on girls as young as 9. Compounding matters was the company's aggressive lobbying efforts to get state governments to include Gardasil as part of mandatory school-immunization programs.By early 2007, the drugmaker announced it would suspend its lobbying efforts after the governor of Texas, who had received campaign contributions from Merck, side-stepped his own state Legislature to impose a mandate that schoolgirls get the vaccine.The vaccine, which requires a trio of shots, has a price tag of $360. While many private health plans provide coverage for Gardasil, levels of coverage can vary. In 2008, sales are estimated to remain flat at $1.5 billion.If regulators approve the vaccine for boys and men, the additional market could boost sales of Gardasil by at least $500 million by 2013, according to the projections of Wall Street analysts."The market potential for males is as great as it was for girls," said Ryan, the analyst with Deutsche Bank. "Even if it's only half, it could mean $800 million in revenues."Still, Merck is likely to encounter some of the same challenges with young men that it faced with young women, she said."We have to assume that the inroads to these markets will be limited," Ryan said.WEIGHING THE RISKSThe first barrier may be pediatricians, some of whom are less than excited about the widening market.Rosario Zambrano, a Morristown pediatrician, said she has pulled back on recommending the vaccine to patients, especially preteen girls, because of emerging side effects. According to the medical literature, one of those effects can be fainting, which Zambrano said happened to two of her patients."It makes me nervous," she said. "I have to weigh the pros and cons and the risk of side effects at that tender age of 11; I would rather err on the side of caution."Parents of boys, she said, haven't asked many questions yet about the vaccine."If we have older teens and I already know they're sexually active, we will tell them about the vaccine," Zambrano said.Dahlia Hall, a pediatrician in Millburn, said some parents already understand the significance of offering the vaccine to boys."Most people recognize the importance of prevention," she said. Yet, side effects are always a worry. "What we're hoping for is lifetime prevention, but we really don't know. Anything new is always difficult. The key thing is to try to listen to the parents and their concerns."Barbara Loe Fisher, president of the National Vaccine Information Center, said her group, which is generally critical of vaccine use, has concerns about the side effects occurring in girls and young women vaccinated with Gardasil."We should not be expanding the numbers of children who will be subjected to the risks of this vaccine," she said.According to the adverse-event reports compiled on Gardasil, the vaccine has been blamed for causing a range of side effects, including some deaths, seizures and fainting.Rich Haupt, who heads Merck's clinical-development program for Gardasil, said the proper systems are in place to monitor and evaluate how it is working, and there are strong reasons for vaccinating males."I think people underestimate the diseases caused by HPV," Haupt said during a recent telephone interview. "There is a significant disease burden in men. There is a value to vaccinating them."In addition to genital warts, HPV can cause penile cancer and anal cancer. Merck did a separate clinical trial studying Gardasil's effectiveness and safety among homosexual men, where the incidence of HPV-related anal cancer is more prevalent.During an annual business briefing last month, Kenneth Frazier, the president of Merck's global human health business, acknowledged Gardasil might be a tougher sell when it comes to both males and older women.The company has failed to persuade regulators to approve the vaccine for women up to the age of 45. On Friday, the Food and Drug Administration made a second request for Merck to provide additional data before it would make a decision to approve Gardasil for older women."As we look to the additional populations, we recognize the challenge is greater and the peak vaccination rates are likely to be lower than they will ultimately be for the adolescent female population," Frazier said. "We are, however, focused on continuing to drive revenue with Gardasil."Susan Todd may be reached at stodd or (973) 392-4125.=====«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»§ - PULSE ON 21st CENTURY ALTERNATIVE MEDICINE! §Subscribe send email to: - «¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤«¤»¥«¤»§«¤»¥«¤»§«¤»