Shares in Biogen Idec dipped 2.7% not only because the Food and Drug Administration said it would take an extra three months to review its key multiple sclerosis drug, BG-12, but because an Abbott Laboratories kidney cancer medicine that in some ways works similarly to BG-12 failed.
FORBES: Biogen Says Its FDA Delay Unrelated To Abbott's Failed Medicine
Although some large companies - including HSBC, Diageo, Anglo-American, Cadbury, Rolls Royce, GKN, BAT, BP, Shell and BG - have had a presence in Brazil for many years, several sectors have been ignored.
Indeed, there are a few of these on his list such as T-MD1 for breast cancer (Roche), alpharadin for prostate cancer (Bayer) and BG-12 for MS (Biogen-Idec).
That promising marketing savvy will now be tested by the opportunity surrounding BG-12.
That puts even more focus on the approval and launch of BG-12 for multiple sclerosis, which is expected later this year.
This begs the question: Did the FDA want more time to think about this issue as it might pertain to BG-12?
FORBES: Biogen Says Its FDA Delay Unrelated To Abbott's Failed Medicine
If patients switch off BG-12, they might be more likely to try Gilenya than go back to Avonex, meaning a lost sale to Biogen.
BG-12 and bardoxolone are unrelated chemical entities with distinct chemical structures.
FORBES: Biogen Says Its FDA Delay Unrelated To Abbott's Failed Medicine
BG-12 reduced these flare-ups by roughly 50% in clinical trials.
Unlike Avonex, Tysabri and almost every other MS drug approved until recently, all of which often require painful injections (and often cause fatigue and depression), BG-12 is a pill.
Does the FDA have new safety concerns about BG-12?
FORBES: Biogen Says Its FDA Delay Unrelated To Abbott's Failed Medicine
By owning full rights to the drug, Biogen will be able to more easily streamline its marketing with other MS drugs, including Avonex and Tecfidera, formerly known as BG-12, a pill that is awaiting FDA approval.
FORBES: In Wise Move, Biogen Spends $3.25 Billion For Rest Of Tysabri. Now What Happens To Elan?
Aside from the hemophilia drugs, the company is also expecting data from a drug for amyotrophic lateral sclerosis and there could be an expert panel for its BG-12 multiple sclerosis pill by the end of the year, with approval expected early in 2013.
FORBES: Biogen's New Hemophilia Drug Could Replace Pfizer's Old One
When results of the second BG-12 study were released, participants remember Al Sandrock, the Biogen researcher who led the way to developing the drug, sitting puffed up in his chair looking at the positive results, euphoric that five years of hard work were paying off.
In response to my earlier post about one of our credit cards being closed due to inactivity, long-time reader and regular commenter BG mentioned that he and his wife have upwards of 150 credit cards.
应用推荐