Amgen's new osteoporosis drug cuts fracture risk

Thursday is a big day for Amgen Inc., as company officials meet with a Food and Drug Administration advisory panel in Washington to discuss their licensing application for a new drug that’s critical to the company’s future success.

So it came as welcome news when the Thousand Oaks-based drug manufacturer saw positive findings published Tuesday in the New England Journal of Medicine.

The studies, paid for by Amgen, found that the company’s osteoporosis drug denosumab considerably reduces fractures, findings that might buttress Amgen’s application.

Amgen Chief Medical Officer Sean Harper said they are pleased with the results.

“We really are excited about the opportunity to review our data and hear the discussion of the panel,” he said. “These are always big events and it’s exciting for everybody, but we’re certainly looking forward to it.”

Panel to look at drug

The Reproductive Health Drugs Advisory Committee will review Amgen’s application for FDA approval to use denosumab to treat osteoporosis in post-menopausal women and to prevent and treat bone loss in cancer patients undergoing hormone therapy.

The FDA uses such committees to get independent expert advice, though it does not have to follow a committee’s recommendation.

The FDA could make an approval decision in October. Most analysts think Amgen’s drug has a good chance of approval, with analysts at Morningstar giving it a 70 percent chance to get approval for those two indications on schedule.

Amgen hopes denosumab will reach well beyond those two treatment areas and has put it in trials that include cancer-related bone damage, prevention of bone metastases in prostate cancer and treatment of rheumatoid arthritis. It could be the company’s next drug to break $1 billion in sales. Analyst sales projections reach as high as $3.5 billion, though some are more conservative.

Drug is vital to company

There’s a lot riding on this drug.

Mitra Thompson, a research analyst with IHS Global Insight in London, writes in an e-mail that other drugs in Amgen’s portfolio are “either losing money or are simply not selling enough to curb the overall slump in turnover.”

“So denosumab’s approval by the FDA is doubly important for the company’s long-term prospects. If the FDA chooses not to approve denosumab, Amgen won’t have many other options left in its pipeline, and it could become a prime target for a takeover.”

How denosumab functions

Denosumab works by inhibiting the process that naturally breaks down bone in the body. The body regularly breaks down and builds up bone. By inhibiting the breakdown, denosumab leads to stronger, denser bones less susceptible to fracture.

For the Journal’s studies, researchers injected 60 milligrams of denosumab twice a year for three years into more than 7,800 post-menopausal women with osteoporosis. Compared with the placebo, denosumab reduced the women’s vertebral fractures by 68 percent, their hip fractures by 40 percent and nonvertebral fractures 20 percent. The Journal concludes that the reduction is “significant.”

In a second, smaller study of more than 1,400 elderly men undergoing hormone treatment for prostate cancer, researchers found a 62 percent decrease in new vertebral fractures.

Denosumab has a strong safety profile. The major concern about long-term use noted in the Journal relates to possible effects on the immune system, but researchers did not observe an increased rate of serious infections related to denosumab. They did report, however, significant increases in eczema and hospitalizations for cellulitis, a skin infection.

The FDA panel is expected to address Thursday whether there should be additional safety restrictions or studies. Regulators also have concerns about whether the drug may hasten tumor growth.

New alternative

Amgen has stressed that the twice-yearly injection is easier for patients than taking pills.

The early detection and treatment of those at risk of osteoporosis complications has created great strides in the past 15 years, said Dr. Felicia Cosman, clinical director for the National Osteoporosis Foundation.

In addition to lifestyle, nutrition and exercise guidelines, there have been dramatic changes in treatments, with several medications available.

“One of the big problems that we have in the field is that, for many reasons, people don’t seem to stay on their medication,” she said.

That’s why new drugs, such as denosumab, which offer another alternative for patients are welcome, she said.

Impact on stock price

Amgen’s stock rose $1.57 to close at $62.81 Tuesday.

Denosumab already has played heavily into Amgen’s share value. On July 8, a day after positive trial data were released, the company’s stock jumped 14 percent.

Denosumab was initially discovered about 15 years ago and the first studies in people began in 2001. The proposed trade name is “Prolia.”

According to Amgen’s annual filing, it expects growing competition among drug manufacturers working on new bone loss treatments, and “if denosumab is approved, we would need to significantly expand our sales and marketing capabilities to support its successful launch.”

The drug already is driving Amgen to grow in certain areas — hiring new staff and expanding its facilities in Puerto Rico to handle production.

Company spokeswoman Sarah Reines declined to speculate about whether the drug’s approval would result in new jobs. At the end of 2008, Amgen had 16,466 employees globally, about 6,500 of whom work in Thousand Oaks.

Amgen will handle its own commercialization for osteoporosis and oncology in the U.S., but the company has created an agreement with Daiichi Sankyo Co. to give that company exclusive rights to develop and commercialize denosumab in Japan, and recently announced it will work with GlaxoSmithKline to commercialize denosumab for osteoporosis in Europe, Australia, New Zealand and Mexico.

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