No Read Through to Biogen (BIIB) from Teva (TEVA) Copaxone IPR Result - Jefferies

August 25, 2016 7:49 AM EDT
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Jefferies says don't read through to Biogen (Nasdaq: BIIB) from Teva's (NYSE: TEVA) Copaxone IPR decision.

The firm said, Although there are similarities to the IPR for BIIB’s Tec patent (hearing upcoming in Nov), there are differences that suggest one should not read through from one to the other, in

  1. in the TEVA IPR, the Board decided a physician would not avoid a high dose because it did not have increased efficacy over a low dose, which may imply that not having any efficacy in lower doses would be persuasive to not dose down in an MS treatment (as was the case in BIIB’s ph.II);
  2. the doses in the prior art are not equivalent to the dose in the patent (as was the case with TEVA); and
  3. BIIB has a number of key considerations that support their case, i.e., the unexpected improved efficacy of the 480mg dose, Tecfidera’s commercial success, an unmet need, and industry praise.

Also in the TEVA IPR, the Board defined an MS expert as having experience in treating MS, a key disagreement in the BIIB/FWP interference (FWP’s lacks clinical experience) – although we think the Board will accept FWP’s expert, we reemphasize experts will be integral to the interference and IPR, as in the TEVA decision. While the entrance of a 40mg 3x/week Copaxone generic could theoretically impact BIIB’s MS franchise by further swaying payers to prefer Copaxone over Avonex, Plegridy, or Tec, we note payers have been mixed in how much they’ve even required daily generic glatiramer vs. 3x/wk branded Copaxone, and generally enable physicians to prescribe IFNs if deemed appropriate for pts; additionally, a great deal needs to still play out in the TEVA case - given the decision used a contentious definition of prior art for the FDA communication (which could be viewed as insufficiently public).

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