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BG-12 Positive in First Phase III; Biogen Poised for Oral MS Entry

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Biogen has a confirmatory trial ongoing, designated CONFIRM, which is testing BG-12 against both placebo and an active comparator, Copaxone (glatiramer acetate) from Teva Pharmaceutical Industries Ltd. A readout of those data is expected in the second half of this year. Pending success in that trial, the company aims to file a new drug application in the first half of 2012, Williams said.

Yet where the drug will fit within the competitive oral MS drug space likely will come down to the detailed data. Based on other studies showing similar "p" values, Leerink Swann analyst Joshua Schimmer estimated an annualized relapse rate for BG-12 of "at least close to 35 percent," which would put it on par with other oral MS drugs, as well as the ABCR injectable or infused therapies: Biogen's Avonex (interferon beta-1a), Bayer AG's Betaseron (interferon beta-1b), Teva's Copaxone and EMD Serono Inc.'s Rebif (interferon beta-1a).

Right now, the top oral competitors include Novartis AG's Gilenya (fingolimod), which made headlines last year as the first approved oral MS therapy, based on Phase III data showing a 52 percent reduction in relapse rate at one year vs. injectable interferon beta-1a. The Basel, Switzerland-based firm reported additional data this week at the American Academy of Neurology (AAN) meeting in Hawaii, which demonstrated that Gilenya-treated patients who were new to therapy had a 37 percent reduction in the risk of three-month confirmed disability progression compared to placebo. Those previously treated with alternate therapies before Gilenya had a 30 percent reduction. (See BioWorld Today, Sept. 23, 2010.)

Another competitor coming down the pike is Paris-based Sanofi-Aventis SA's teriflunomide, another late-stage oral MS drug. In one Phase III study, teriflunomide demonstrated a 31 percent annualized relapse rate reduction (p = 0.0002). But going into AAN, it's laquinimod, from Jerusalem-based Teva and Swedish partner Active Biotech AB that has gotten the most attention. That drug previously hit its endpoint in the two-year Phase III ALLEGRO study, demonstrating significant reduction in annualized relapse rate compared to placebo, and analysts are awaiting detailed data later this week. (See BioWorld Today, Dec. 10, 2010.)

The expectations are high for laquinimod, possibly too high. Teva's stock (NASDAQ:TEVA) took a slight hit Monday, dropping $1.48 to close at $48.98, as investors worried the data might not be as good as expected. Results from the abstract showed a 23 percent reduction in annual relapse rate and a 36 percent improvement in EDSS scores. But, as Corey Davis, an analyst at Jefferies & Co. Inc. noted, "it's really about laquinimod's safety that holds the key, as anything less than a squeaky clean profile will be a disappointment."