Amgen Data Fails to Impress

0




Editor’s Note:

A version of this story appeared in the Dec. 17 print edition’s healthcare and biotech industry column.


Amgen shares hit a five-year low on Monday, despite the company having released solid data over the weekend on a potential blockbuster osteoporosis treatment.


The Thousand Oaks-based biotech giant said late Friday that denosumab hit both its primary and secondary goals of increasing bone mass in women undergoing a breast cancer treatment that causes bone loss due to reduced estrogen in the body.


In a two-year study, presented at the annual San Antonio Breast Cancer Symposium, denosumab showed positive results compared with placebo. Denosumab, which is a injectible monoclonal antibody that researchers had been studying since the mid-1990s, works by blocking certain processes in the body that lead to bone loss.


As a potential treatment both for post-menopausal osteoporosis and bone loss related to certain cancer treatments for both women and men, some industry analysts believe denosumab could become another billion-dollar blockbuster, comparable to Amgen’s now beleagured anemia drug Aranesp.


“Because these women also are post-menopausal this study is one in which our two therapeutic programs intersect,” said Dr. Roger Dansey, Amgen’s director of oncology global development for the drug.


Nonetheless, Amgen shares were $1.47, or 3 percent, to $46.93 in afternoon trading. Earlier Monday, shares fell as low as $46.89, the lowest since December 2002.


Some analysts questioned the drug’s market prospects, noting that the denosumab data was in-line with some drugs already on the market. Amgen is conducting head-to-head study with Merck & Co.’s Fosamax, an oral drug which is due to lose patent protection in 2008.


“With limited long-term safety or fracture-risk data available, we believe physicians may be hesitant to prescribe denosumab in early-stage patients,” said Lazard Capital Markets analyst Joel Sendek in a Monday note to investors.


Amgen hasn’t yet announced when it plans to submit an application to the U.S. Food and Drug Administration, though Sendek anticipates a submission by the end of next year. The company has several studies ongoing, including one on denosumab’s ability to counter bone loss in men undergoing similar treatments for prostate cancer.

No posts to display