This wasn't one of those instant doubles on approval because most investors figured a thumbs-up was likely, but given the last attempt at approval, investors were right to be nervous and discount the value slightly. The stock is up 20% today. Surprisingly, Alkermes
Bydureon is the once-weekly version of Byetta, which has to be taken twice daily. Eliminating 13 shots from the patient's weekly routine should help sell the new medication, but Bydureon won't just be cannibalizing sales from Byetta. Novo Nordisk's
Bydureon is approved as a monotherapy, but only as a second-line indication. That means doctors aren't advised to use Bydureon on a newly diagnosed patient, but could prescribe it for use by itself if patients fail another drug. I don't think that's a major issue, because I doubt there are many doctors who wouldn't try metformin first. Bydureon is arguably a better drug, but "better" may not be necessary in newly diagnosed patients. If the diabetes is controlled -- for the time being -- by a cheap oral generic that's been approved since 1995, there's little reason to give anything stronger. Diabetes is a progressive disease, so Bydureon will get its chance at the patient eventually.
It's also approved for use in conjunction with other oral drugs, so theoretically Bydureon won't have to compete directly with the multi-billion-dollar drugs such as Merck's
With an approval in hand, investors will have to take another breath and hold it until first-quarter results are announced, where we'll get a look at how well Amylin can sell the improved version of the drug.
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