Teva faces double Copaxone woes

Israeli generics giant Teva Pharmaceutical Industries is suffering a couple of Copaxone-related headaches. First, Israel's health ministry appointed a special committee to probe a trial of the MS drug. Allegedly, Teva tested Copaxone on ALS patients--despite the fact that previous trials on mice had failed. Teva maintains that testing Copaxone in human ALS patients was perfectly safe despite the deaths seen in mice taking the drug, because Copaxone had already made it through plenty of human trials for its approval as an MS drug. But an internal investigation by the health ministry's comptroller found that the company didn't submit all the necessary info before trial approval. So the special committee will take a look at the evidence to see whether the ministry and/or the company did anything wrong.

Then, Momenta Pharmaceuticals announced late Friday that the FDA will review its generic version of Copaxone, which is an injectable med. Momenta wants to sell its copycat form in partnership with Sandoz, the generics arm of Novartis. Teva immediately struck back, saying that it will fight a patent challenge and sue the two companies for infringement. Teva contends that Copaxone is protected in the U.S. till 2014 and in Europe through 2015. But Momenta's incipient challenge follows another from Mylan, which last month licensed a version made by India's NATCO Pharma--which is already on the market on the subcontinent and in Ukraine.

Shareholders didn't like the news, and Teva stock plummeted. Will Teva ultimately prevail? Hoping to quell investor panic, CEO Shlomo Yanai told an Israeli newspaper that Momenta/Sandoz probably will have to mount clinical trials of their copycat drug because, unlike many generics, it's an injectable. And even if he's wrong about that, he said, "Teva has a clear answer on the commercial side... We are 'mister generic' and we will know how to do this."

- see the trial probe news at Globes
- check out the Momenta story at Haaretz
- read Yanai's comments at Pharmalot