Jefferies Comments on Biogen (BIIB) Following Further BG12 Phase 3 DEFINE Analysis; Remains Bullish on Prospects in MS Use

Jefferies commented on Biogen Idec (Nasdaq: BIIB) following analysis of previously release data from BG12 Phase 3 DEFINE. The firm maintains a Buy rating and $124 price target on the stock.

New items include:

• Details on DEFINE suggesting that dosing beyond 6-months strengthens its efficacy benefit. According to Jefferies: "The time course curve of the cumulative relapse rate was shown for the first time today, with evidence that the efficacy of BG12 takes 3 months to even start separating from placebo and an acceleration in the separation of the curves after 6 months. This would support the theory that the Phase 2 data for BG12, which dosed patients for only 6 months in a placebo-controlled fashion, may have understated the efficacy of the drug, and gives us increased confidence that the efficacy benefit for BG12 is closer to that reported in the DEFINE study and will likely be replicated in CONFIRM."
  
  
• GI and flushing side-effects fall by month 2. Commenting: "Specifically, flushing rates fall from ~30 percent to ~5 percent to ~3 percent and GI adverse event rates fall from ~25 percent to ~7 percent to ~2 percent in the BG12 arm from months 1 through 3. In both cases, rates of these side effects are indistinguishable from placebo by month 2.
  
  Separately, there was a slight imbalance in rates of low white blood cell counts (4 percent BG12 vs. 1 percent placebo) and lymphopenia (4 percent vs. <1 percent), but these were not associated with any increase in infections (66 percent vs. 65 percent), serious infections (2 percent vs. 2 percent) or malignancies (2 cases in each arm). Rates of liver enzyme elevations were slightly elevated with BG12 (ALT >3x ULN: 6 percent vs. 3 percent, >5x ULN: 2 percent vs. 2 percent), but these generally occurred early in dosing with no cases of Hy's law and did not lead to any withdrawals from the study."

Jefferies continues to be positive on BG12 and CONFIRM, saying, "In our discussion with the lead investigator, we believe that the data from DEFINE remain robust using multiple different statistical analyses and that the annualized relapse rate reduction remains at the ~50% level under alternate methods of accounting for study discontinuations...while the small size of CONFIRM means that statistical superiority to Copaxone could be difficult to demonstrate, we nonetheless believe that there will be a strong trend towards better efficacy for BG12, and combined with oral dosing, a strong safety profile and 150,000 patient years of postmarketing safety data, we have increased confidence that BG12 will emerge as the leading front-line treatment for MS."

Click here for more analyst color on Biogen, or here for a ratings history.

Biogen shares are up 5 percent on the session.

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