Biogen Seeks Approval for BG-12

Biogen Idec (BIIB - Analyst Report) recently announced the submission of a new drug application (NDA) for its oral multiple sclerosis candidate, BG-12. The NDA was based on data from the phase III DEFINE and CONFIRM studies which showed that treatment with BG-12 led to a significant reduction in disease activity in multiple sclerosis patients. Moreover, the candidate had a favorable safety and tolerability profile.

Biogen will be filing for EU approval as well shortly. A response regarding the acceptance of the NDA should be out in a couple of months. We believe BG-12 could become a leader in the oral multiple sclerosis market once launched.

In addition to announcing the submission of the BG-12 NDA, Biogen said that it gained US Food and Drug Administration (FDA) approval for Avonex Pen and a new dose titration regimen. The availability of Avonex Pen should help improve convenient administration of Avonex, which is approved for the treatment of relapsing forms of multiple sclerosis. Avonex Pen’s convenience of administration should improve patient independence and reduce injection anxiety.

Meanwhile, the new dose titration regimen, which increases the dose gradually, should help reduce the incidence and severity of flu-like symptoms which could occur at the commencement of treatment. Avonex Pen gained approval in the EU and Canada in 2011.

Neutral on Biogen

We currently have a Neutral recommendation on Biogen, which carries a Zacks #3 rank (short-term “Hold” rating). Key products, Avonex and Tysabri, should continue contributing significantly to sales. Longer-term growth could be driven by BG-12. However, we are concerned about Novartis’ (NVS - Snapshot Report) Gilenya which is competing directly with Avonex and Tysabri. The multiple sclerosis market could become more competitive with the entry of oral treatments being developed by Sanofi (SNY - Analyst Report).