Teva Pharmaceutical Industries Ltd. will test its experimental multiple-sclerosis pill in combination therapies as the company mounts a response to oral competitors to its best-selling injection Copaxone.
The Israeli company is likely to start two clinical trials next year combining laquinimod with other drugs, President of Global Research and Development and Chief Scientific Officer Michael Hayden said in an interview at an MS conference in Lyon, France. One of the trials may seek to combine laquinimod with Copaxone, Hayden said.
“We haven’t pulled the trigger on it but we are getting very close,” Hayden said, referring to the possible combination with Copaxone. In multiple sclerosis, “nobody uses combination therapy. It’s really strange.” Combining another treatment to laquinimod would mean a “paradigm change” in the the care of multiple sclerosis, Hayden said.
“With the dual mechanisms, we have a chance to do that,” he said.
Teva is searching for a new approach to MS treatments as Copaxone’s dominance begins to be threatened by pills such as Novartis AG’s Gilenya and Biogen Idec Inc.’s BG-12, which is awaiting a decision from U.S. regulators. Teva also said today that it’s submitting its three-times weekly version of Copaxone for approval in the beginning of 2013.
While laquinimod failed to beat competing products in clinical trials on reducing the rates at which patients experience relapses, Teva is continuing development because studies suggest it slows the deterioration in physical ability caused by the disease. Teva is separately testing the pill in a final round of human trials at a higher dose as it seeks to verify that the drug effectively delays loss of muscle control and balance.
A U.S. federal judge in New York handed Teva a ruling in June that may keep generic versions of Copaxone off the market until 2015. The victory may give Teva more time to switch patients to a new, higher-dose version of the drug. Teva said yesterday that a late-stage trial of a longer-acting formulation reduced MS relapses more than a placebo and showed a ‘‘favorable” safety profile.
With a three times a week dose, patients on Copaxone “can focus on having the week-end without it,” Hayden said. “Weekends are times for different things, to be able to put your medication away, have a weekend without having to worry about it. For me, that would be an advantage.”