(from NP February: this replaces a previous post on the Teva topic)
Teva‘s CEO Jeremy Levin is understandably concerned about protecting Teva’s MS franchise drug, Copaxone, particularly since Teva/Active Biotech‘s oral MS entrant, laquinimod, has underperformed thus far, and must go into further Phase III testing. Unfortunately, Teva chose a ‘the best defense is a good offense’ tack in defending Copaxone, filing a ‘Citizen’s Petition’ with the FDA seeking to trigger additional regulatory review of Biogen-Idec‘s BG-12 as a safety risk, specifically claiming that it is associated with renal damage. Teva’s ‘petition’ asked that the FDA convene an Advisory Committee before approving BG-12 (and all other new MS drugs, but BG-12 was the obvious target).
Teva’s cynical ‘Citizen’s Petition’ is nothing more than a self-serving act of sabotage, intended to delay BG-12, and to thereby protect Copaxone sales as long as possible. NIR’s first reaction was to decry this as poor sportsmanship,as it reminded us of the 1994 incident when figure skater Tonya Harding sent a thug with a tire iron to injure her rival Nancy Kerrigan, and ostensibly improve her own chances in the competition. By filing this petition, Teva is trying to hamstring the soon-to-be-frontrunner, using the FDA as its weapon.
But in a pharma world where the stakes are so high, ‘sportsmanship’ undoubtedly sounds like a quaint and irrelevant concept. This decision by Teva needs to be framed in a more pragmatic fashion as the mistake that it is in this context. Teva is acting as if this is just an extension of the branded versus generic wars, wherein generic companies have been subjected to fierce attacks by pharma companies defending their branded drugs. But the generic context is one where the playing field is already uneven, with the generic subject to far less regulatory scrutiny than its branded forebear. That is not the case in the NCE context, where there is no lack of FDA attention upon safety issues.
To claim a specific safety risk for a competitor’s NCE already under FDA review, and to demand additional regulatory scrutiny, is a dangerous precedent. If the pharma industry resets its competitive tactics in accord with this ‘no holds barred’ standard, every pharma company will feel obliged to devote resources to the regulatory sabotage of its putative competitors. Given its horror of public and Congressional criticism, the FDA might well be coerced into adding additional layers of oversight to a process already rife with burden and delay, elongating the already draining marathon of regulatory review.
(this replaces a previous post on the Teva topic)
The prospect of cataclysmic retaliation for any use of nuclear weapons has been the cornerstone of nuclear deterrence ,the concept that no rational entity would invite Armageddon via first use–the principle of Mutual Assured Destruction (MAD). Now, at a time that the pharma industry needs to rethink the traditional boundaries of competitive and precompetitive space, Teva has taken a step backwards, raising the risk of a pharma arms race in which there will be no winners. They seem to think that this is clever, but in fact, it is short-sighted and foolish.