In a bid to calm investors, Shlomo Yanai tells an Israeli newspaper that there is no reason to be alarmed that the FDA will approve a copycat version of its blockbuster Copaxone, a brand-name multiple sclerosis drug, that Momenta Pharmaceuticals and Sandoz would like to sell.
The generic drugmaker intends to file a lawsuit for patent infringement against Momenta and Sandoz within the 45-day period provided under the Hatch-Waxman legislation, a move that will trigger a stay of the FDA approval until the expiration of a 30-month waiting period or a court decision in its favor.
"Things must be put into proportion," Yanai tells Maariv. "Despite Copaxone, Teva's main business is generics, from where we get our income. This is a growing business and there are exceptional opportunities...Copaxone does not resemble what everyone is familiar with in the generic world. It is a product that must be injected daily and affects the body's nervous system. The obstacles Momenta will have to overcome will not end until 2014," referring to the likely need for clinical trials.
"Even if I am wrong in my estimate about the entry of a generic version to the market, Teva has a clear answer on the commercial side for this day. We are 'mister generic' and we will know how to do this," Yanai says confidently.
Meanwhile, Yanai adds that Teva is conducting trials on other products for multiple sclerosis and the company would have results for these trials well before anyone gains approval for a generic version of Copaxone.
Separately, the Israeli Ministry of Health and the Public Complaints Commissioner have appointed a special committee to study how Teva Pharmaceutical conducted a trial of its Copaxone multiple sclerosis drug.
Teva allegedly tested Copaxone on ALS patients, despite knowing that previous trials on mice with ALD raised doubts about its safety. As early as six months ago, the Ministry of Health comptroller began investigating the conduct of the Health Ministry, which approved the trials, and the Tel Aviv Sourasky Medical Center, where the trials were conducted in conjunction with similar trials in five other countries. Here is the back story.