Biogen (BIIB) received a boost recently with the company presenting promising top-line data on its oral multiple sclerosis candidate, BG-12. The company presented positive results on the use of BG-12 as a monotherapy in patients suffering from relapsing-remitting multiple sclerosis (RRMS).
DEFINE Data
Data from the phase III global, randomized, double-blind, placebo-controlled, dose-comparison DEFINE study showed that BG-12 (240 mg dosed twice/thrice daily) brought about a statistically significant reduction in the proportion of patients experiencing a relapse in disease at two years.
Both doses of BG-12 met the secondary endpoints as well which included a statistically significant reduction in annualized relapse rate, the number of new or newly enlarging T2 hyperintense lesions, new gadolinium-enhancing (Gd+) lesions, and the rate of disability progression. Biogen also reported that the candidate’s safety and tolerability profile was favorable.
The encouraging data on BG-12 is a major positive for Biogen which has been facing additional competition in the multiple sclerosis market in the form of Novartis’ (NVS) Gilenya. Moreover, several companies besides Biogen are working on bringing an oral multiple sclerosis drug to market. These include companies like Teva (TEVA), Sanofi-Aventis (SNY) and Merck KGaA (MKGAF).
BG-12 enjoys fast track status with the US Food and Drug Administration (FDA). The candidate is currently in another phase III study, CONFIRM, with results due in the second half of 2011. BG-12’s approval would help Biogen strengthen its position in the multiple sclerosis market.
Neutral on Biogen
We currently have a Neutral recommendation on Biogen. Key products, Avonex and Tysabri, should continue contributing significantly to sales. Meanwhile, Biogen’s restructuring initiative should help drive the bottom line. We are also pleased with Biogen’s intention to streamline its pipeline development and focus on candidates that represent higher potential. However, we remain concerned about an increase in the occurrence of progressive multifocal leukoencephalopathy (PML) in patients using Tysabri. We are also concerned about the increasing competition in the multiple sclerosis market.
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