Posted on 03/11/2006 8:04:28 PM PST by BenLurkin
An estimated 10 million Americans suffer from osteoporosis, according to the National Institutes of Health. Another 34 million are considered at increased risk for getting the bone disease.
A good many of those patients stand to benefit if a new osteoporosis drug from Amgen (NasdaqNM:AMGN - News) turns out to be successful.
Phase two data on the investigational drug, dubbed Denosumab, was recently published in the New England Journal of Medicine.
The drug was given in twice-yearly injections. A total of 412 postmenopausal women with low bone marrow density were randomly assigned to receive Denosumab, Merck's (NYSE:MRK - News) Fosamax or a placebo.
After one year of following the women, researchers said Denosumab boosted bone marrow density at the hip to from 1.9% to 3.6%. These results were better than the placebo group and in the same range of the Fosamax group.
The data suggest Denosumab will be at least as effective as Fosamax, says Dr. Michael McClung, lead investigator and an assistant director at the Providence Portland Medical Center in Oregon.
If that turns out to be the case, it'll be a coup for Amgen.
The company gained success through its anemia and infection-fighting drugs, used for patients with cancer or those on kidney dialysis. Until recently, however, Amgen's efforts to expand into new disease areas foundered.
Denosumab and three other investigational drugs have potential for success, analysts say. Amgen's drugs dubbed AMG 706 and Panitumumab are being studied against certain cancers, while AMG 531 is being tested against an autoimmune bleeding disorder.
"After many years of disappointment, the company's pipeline is showing real potential," Dr. Gbola Amusa, analyst with Sanford C. Bernstein, wrote in a recent note.
Merrill Lynch analyst Eric Ende also is guardedly positive.
"We continue to view these (products) ... as potential best-in-class drugs," Ende wrote in a report. "However, if clinical data suggest narrower uses, or regulatory delays, the next inflection in growth (for Amgen) may be delayed or slowed."
Heavy Investments
As its older drugs lose patent protection overseas -- U.S. patents still have five years or more of protection -- Amgen is relying on these investigational products to drive future sales.
Amgen will have to spend a lot of money to support the drugs. It plans to boost research and development spending by $700 million to $900 million this year from last year, company officials said during a January earnings call. Many of these dollars will go to support Denosumab and its siblings in clinical studies.
Though Denosumab data appear strong, analysts caution that results are still based on early studies. Late-stage results on Denosumab won't be available until mid-2007.
Among Denosumab's potential benefits is that it might be simpler for some patients to use than the Fosamax pill. That's because Denosumab would require only twice-yearly injections in a doctor's office. This would ease a cause for headache among doctors: keeping patients on the drugs.
The point of taking osteoporosis pills is to help healthy patients prevent fractures caused by brittle bone. But patients often quit the drugs because they don't notice any obvious benefit -- even when the benefits are real.
Other patients quit because they suffer upset stomachs. Patients are supposed to take Fosamax with just water and not eat or lie down for half an hour afterward.
"Both Fosamax and (Procter & Gamble's (NYSE:PG - News)) Actonel are very effective, but they only work if patients take them," McClung said. "Side effects are only one of the reasons patients quit. These drugs are mostly prescribed by primary care doctors who only have minutes to explain to patients how to take the drugs, and the importance of them."
Widening Scope
Amgen plans to examine Denosumab's usefulness across a range of bone diseases, with the goal of expanding the drug's target market.
Aside from osteoporosis, it also will look at bone loss in patients being treated for rheumatoid arthritis, cancer and other diseases, says Dr. Lorie Fitzpatrick, Amgen's director of global development.
'Watershed Year'
Bernstein's Amusa says he expects to see more data this year and next year that support higher long-term sales forecasts and higher growth rates.
He sees 2007 as Amgen's "watershed year," with filings and approvals of up to four new drugs.
Merrill's Ende doesn't see Denosumab bringing in revenue until 2008, when he expects the drug to generate sales of $354 million.
For now, Amgen's current lineup of products is still driving growth. The company posted total sales of $12.4 billion last year, up 18% from 2004. Earnings gained 33% to $3.20 a share.
How much does Fosamax cost? Is it perscription only?
If you have dental extractions it will not heal, or take many months to heal. IMHO down the road the treatment may be worse than the disease, osteoporosis.
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