Amgen's Bone-Loss Drug Faces Marketing Hurdles

Wall Street has set an exceptionally high bar for Amgen's new bone-loss treatment. Shares of the world's largest biotechnology company have jumped 30% since May, to 62, largely on news of clinical trials that showed the drug is at least as effective as standard osteoporosis treatments. At press time, an advisory board of the U.S. Food & Drug Administration was expected to recommend the agency approve the drug, known as denosumab.

Bone loss is a huge and growing medical problem: Up to 50% of women and 30% of men will suffer an osteoporosis-related fracture in their lifetimes, according to the International Osteoporosis Foundation. Amgen says its treatment is also effective in preventing bone loss in post-menopausal women and in some cancer patients. If the FDA approves it for those uses, the drug could bring in as much as $3 billion a year, analysts predict.

At a time when the country is focused on reforming health care, however, some experts are asking an important question: Can the U.S. afford to protect the bones of millions of aging baby boomers? Mayo Clinic professor of medicine Dr. Sundeep Khosla isn't convinced Amgen's drug is that much better than older, more affordable alternatives, such as Merck's Fosamax, now available as a generic for as little as $100 a year. Amgen has not talked about pricing, but because denosumab is a biologic drug, it will likely cost more than even the priciest alternatives, such as Roche's Boniva and Novartis (NVS)'s Reclast, which cost up to $2,000 a year. "If there's only a marginal difference, you really need a reason not to use those older drugs," says Khosla.

Denosumab performed well in a pair of studies published in the New England Journal of Medicine on Aug. 11. In post-menopausal women with osteoporosis, it reduced hip fractures by 40% and spine fractures by 68%, when tested against a placebo. Yet Amgen has done just a handful of trials comparing denosumab to currently marketed osteoporosis drugs. And those trials only measured bone density—not fracture risk. Without more definitive studies, doctors may choose to stick with old standbys.

Amgen is playing up the fact that denosumab requires nothing more than a twice-yearly injection. Other bone treatments require intravenous infusions, and Fosamax is a pill that's taken weekly or daily. As for the cost, Dr. Roger M. Perlmutter, Amgen's executive vice-president for research and development, said in a June interview: "We don't intend to be exploitative. We want the value proposition to be clear."

SIDE EFFECTSThe biotech company's ability to communicate the drug's benefits could be complicated by the FDA, which is likely to zero in on side effects. Denosumab is an antibody that attacks bone loss in a completely new way—by blocking a protein that normally stimulates bone-destroying cells. The long-term implications of interfering with that pathway are not yet clear, but some patients in the studies suffered serious infections or cancers of the ovaries, stomach, and other organs. Amgen is proposing several post-approval studies to better assess the risks.

Denosumab may be the biggest marketing challenge the 29-year-old biotech has ever faced. The market for osteoporosis drugs is $5 billion but shrinking as insurers push patients to switch to generic Fosamax. That has sparked a marketing war: In 2008, Roche spent $92 million advertising Boniva, according to TNS Media Intelligence, while Novartis spent $53 million pitching Reclast. Amgen will have to put plenty of promotional muscle behind denosumab to convince doctors—and insurers—that the drug is a cut above those treatments.

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