Teva ($TEVA) just won't give up on delaying generic Copaxone. Its latest tactic: filing a citizen petition with the FDA to once again push for full-scale, placebo-controlled clinical trials for all copies of its multiple sclerosis med.
This time, Teva's argument centers on gene expression associated with Copaxone use. According to Teva, its petition offers new scientific data on gene expression, along with evidence that supports the case for trialing its rivals. It will now be up to the FDA whether to stall approvals of Copaxone's competitors--a move the Israeli drugmaker says is necessary.
"It would be contrary to the public's health and welfare to approve a purported generic glatiramer acetate product that, based on current analytical technologies and confirmed by techniques such as gene expression evaluation, at best can be shown to be similar, but clearly not the same as, Copaxone," it said in a statement.
Teva has tried time and again to ward off competition to Copaxone, and with good reason: The blockbuster brings in about 20% of Teva's sales and roughly half of its profits. But so far, its efforts haven't proven very effective. While the Supreme Court will hear its patent argument in an appeal this fall, the court has refused to delay generics from two different partnerships, Novartis' ($NVS) Sandoz and Momenta Pharmaceuticals ($MNTA), and Mylan ($MYL) and India's Natco Pharma.
If SCOTUS rules in Teva's favor, any drugmakers who have pushed forward with their versions will be on the hook for reparations. But as the generics giant argued in April, the court may not hand down a decision until June 2015--"effectively too late to prevent irreparable harm to Teva."
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