In the wee hours of the morning Amgen issued this press releasein conjunction with a researcher's oral presentation at a scientific conference in Barcelona on the results of a head-to-head study comparing the biotech company's experimental osteoporosis drug known as D-mab with Fosamax. D-mab is the focal point of AMGN's drug development pipeline.
The detailed data essentially back up what Amgen had announced in what's referred to as a "topline results" press release back in January. Topline results are typically just a taste of a test's outcome. Companies often hold back taking a deep dive for a more prestigious presentation of the numbers at a scientific meeting and/or publication in a peer-reviewed medical journal.
D-mab increased bone mineral density in the hips--a key measure of osteoporosis drug effectiveness--40 percent more than Fosamax. Merck makes the branded Fosamax which went generic earlier this year.
D-mab is a twice-a-year shot and Fosamax is a once-a-week pill. Doctors say compliance--patients taking their meds--is a challenge with the most common osteoporosis drugs in part because you have to take them with a tall glass of water and then stay upright for at least half an hour.
On a conference call from Barcelona this morning the lead clinical trial investigator and an Amgen executive touted the results. But some analysts remain concerned about infections among D-mab patients and pressed the issue during the q. and a. portion of the call. The top researcher responded by saying, "I'm very impressed by the low number of infections. I'm more reassured than concerned."
Outgoing Bear Stearns biotech analyst Mark Schoenebaum writes in a research note to clients, "Overall, the data look solid on safety." Miller Tabak's Les Funtleyder says, "The key issue will be the safety concerns particularly as they relate to infections which we believe will continue to overhang the drug until it is widely used in practice."
And George Farmer at Wachovia writes, "We continue to question whether both efficacy and safety data from (a different, more crucial study) will be compelling enough to warrant use of D-mab over generic (Fosamax) in the post-menopausal osteoporosis setting." Wachovia and Bear make a market in AMGN.
Amgen shares which rallied yesterday are giving back much of Tuesday's gains in early trading today. Investors are waiting for the results of the much bigger (8,000 women) study which are expected later this year.
D-mab is short for denosumab. Whenever you see "mab" at the end of a scientific drug name it means it's a monoclonal antibody. We're waiting for Amgen to give the drug its commercial name. Any suggestions? Write to me at Pharma@cnbc.com.
Questions? Comments? Pharma@cnbc.com