First, it is alleged that Teva tested Copaxone on amyotrophic lateral sclerosis patients despite the failure of the drug in previous trials on mice. However, the company vouched for the safety of the drug citing the successful trials it has conducted previously for developing the drug for multiple sclerosis.
But the Israel’s health ministry appointed a special committee to probe a trial of the multiple sclerosis drug as an internal investigation by the health ministry’s comptroller found that the company did not submit all the necessary information before trial approval. The special committee will check for any irregularities in the Teva data.
Recently the company suffered another major blow with the FDA’s acceptance of Momenta Pharmaceuticals’s generic version of Copaxone. Momenta and its partner, the Sandoz unit of Novartis, submitted a generic Copaxone application to the FDA, which accepted the filing for review.
But Teva maintains that it has patent protection on Copaxone in the US until May 2014 and in most of Europe until 2015. Teva said that it will file a lawsuit against the two companies to prevent them from making a generic version of its drug. It also said that it will sue both Momenta and Sandoz for patent infringement.
Teva is reportedly facing another challenge from Mylan which has licensed a version made by India’s Natco Pharma.