THOUSAND OAKS, Calif. (
shares rose Wednesday after U.S. regulators approved last night the company's injectable osteoporosis drug Prolia earlier than expected.
Prolia is widely seen as Amgen's most important new drug and a key driver for the company's future growth. Prolia is administered via injection twice a year and will be used initially as a treatment for osteoporosis in post-menopausal woman.
The U.S. Food and Drug Administration approved Prolia almost two months before the expected approval date of July 25. European regulators approved the drug for use there last week.
Amgen hopes to later expand Prolia's approval into more commercially lucrative cancer indications, where it can treat bone-related side effects.
Amgen shares were up 3.5% to $52.52 in Wednesday pre-market trading.
The stock's positive reaction to the Prolia news was due both to the earlier-than-expected FDA approval but also because Amgen priced Prolia higher than expected at $825 per injection, or $1,650 per year.
"We view this positively as it appears that Amgen was pricing Prolia with the oncology indications in mind," wrote Citi analyst Yaron Werber in a Wednesday morning research note to clients. "Using this price, the annual cost for the cancer indications (once monthly at double the dose) translates to $19,800 vs. our projection of $12,240." Werber rates Amgen a buy with a $64 price target.
Tuesday night's approval of Prolia for osteoporosis does come with some strings attached. The drug is approved only for post-menopausal women at high risk for bone fracture and the FDA is requiring Amgen to conduct long-term safety monitoring of the drug and implement a risk-management plan to communicate the drug's risk and side effects to patients and doctors.
Prolia's twice-yearly injections will compete against pills for osteoporosis that are taken weekly or monthly.
The FDA is currently reviewing Prolia for use in various cancer indications, where the drug will be used to stop bone loss related to cancer and cancer treatments. Amgen is awaiting results later this year from a large, phase III study to determine if Prolia can stop the spread of prostate cancer to a patient's bones.
Analysts expect Amgen to earn $5.12 on total revenue of $15.1 billion in 2010.
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-- Reported by Adam Feuerstein in Boston.
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