On its fourth-quarter earnings conference call, Biogen Idec's (NASDAQ:BIIB) management gave investors a look inside the biotech. From pipeline data to new drug launches to sales of established drugs, here are five things Biogen's management wants you to know.
Additional BIIB037 study data will be presented at the upcoming ADPD meeting in March. -- Douglas Williams, Biogen's executive vice president of research & development
Biogen disclosed some phase 1 data for its early-stage Alzheimer's drug, BIIB037, at an investor conference last December, but the information released was sparse on details. Management, which has seen the full data set for the anti-amyloid beta antibody, is clearly impressed since it's jumping straight to a phase 3 trial.
The Alzheimer's Disease and Parkinson's Disease, or ADPD, meeting March 18-22 will be the first time investors get more details about BIIB037's activity. While the results have drawn a lot of attention so far, just keep in mind there are plenty of examples of Alzheimer's disease drugs that looked good in early-stage trials only to flop when tested in a larger population.
Over the past 6 months, our data suggests that our portfolio has consistently captured roughly half of all newly diagnosed patients and switch patients in the U.S. -- Stuart Kingsley, executive vice president of global commercial operations
Kingsley was referring to Biogen's portfolio of multiple sclerosis drugs. Given all the competition in this space, it's quite impressive that the company is able to capture half of the patients starting on a new medication. Having a solid portfolio of differentiated drugs certainly helps since it can serve patients' needs from Tecfidera, an oral medication, to Tysabri, which is stronger but with more severe potential side effects.
Capturing the other half of the market might be tough, especially with generic versions of Teva Pharmaceuticals' MS drug Copaxone potentially coming to market shortly. The best bet Biogen has comes from Plegridy, which only has to be injected every other week.
To date, roughly half of Plegridy prescriptions have come from Avonex switches. -- Kingsley
Unlike Tecfidera, which zoomed to blockbuster status without much cannibalization of Biogen's other multiple sclerosis drugs, many of the patients starting Plegridy are coming from Avonex. That's not particularly surprising since Plegridy is basically a longer-acting version of Avonex, but it means Biogen isn't benefiting much from those switches in the short term. Longer term, Plegridy's patents are likely to hold up longer than Avonex's patents, so switching patients could have an effect on Biogen's revenue down the line.
Some of the other half of the switches to Plegridy might be coming from Biogen's other drugs, but it's probably a minor fraction. Most are likely switches from other drugs in the same class -- Bayer's Betaseron, Novartis' Extavia, and Pfizer and EMD Serono's Rebif -- or from Copaxone, all of which have to be injected more often.
Importantly, we have not noticed a meaningful change in Tecfidera discontinuation rates. -- Kingsley
Growth of Tecfidera sales has slowed down, which isn't that surprising this far into the launch. Much of the high growth rate in the beginning of the launch was from patients interested in switching from an injected medication to an oral medication. As that bolus of patients is drawn down, the growth rate will slow.
The worry was that the slowing was also due to the disclosure in November that one patient taking Tecfidera was diagnosed with progressive multifocal leukoencephalopathy, or PML, a potentially fatal brain infection. The FDA subsequently changed the label to let doctors know about the risk of PML.
Fortunately, as noted by Kingsley, doctors aren't switching patients off Tecfidera because of the potential risk. If doctors aren't discontinuing use, they're probably not avoiding starting treatment because of the risk, either.
The U.S. launch of Eloctate has been proceeding to plan, ending the year with share in the mid-single digits with over 60% of hemophilia treatment centers prescribing after two quarters on the market. -- Kingsley
Eloctate is Biogen's new drug for hemophilia A. Management might think the launch is going to plan, but it's a pretty slow uptake despite Eloctate requiring fewer infusions than Baxter's Advate -- once every three to five days versus Advate's every second or third day. Even if Biogen is able to get into the other 40% of hemophilia treatment centers, it's still going to have to increase the penetration rate to have a meaningful share of the market.
Advate has been on the market for more than a decade, so there's quite a bit of brand loyalty. Switching medications means working out a new infusion schedule, which might be more convenient in the long term, but could result in more bleeding while the schedule is worked out.
Biogen's best bet is to hope that initial users like the less frequent infusions so much that doctors take their experience and recommend it to their other patients.