Doubling up the dose of Teva Pharmaceutical Industries’ multiple sclerosis treatment Copaxone can significantly increase its efficacy in reducing relapses and new lesions, according to a Phase II trial.
Teva said it would now press ahead with a Phase III study of the new 40mg dose, due to start in the second half of the year. The results are expected in 2008 and, if approved, the new dose would strengthen Copaxone’s labelling against its rivals in the MS therapeutic category and lend additional momentum to the drug, which made $1.8 billion in sales in 2005, up 26%, and is Teva’s biggest product.
The news also offsets some of Teva’s disappointment after the Israeli company and partner Lundbeck were forced to abandon development of an orally-active formulation of Copaxone last month.
The 90-patient study found a 38% greater reduction in MS lesions as measured by magnetic resonance images (MRI) of the brain in patients taking the higher dose compared with those taking the already approved 20mg dose of Copaxone. In addition, patients taking 40mg saw a reduction of 77% in their annual average relapse rate, when compared to the years preceding enrollment into the study. For the lower dose the reduction was 62%.
There was no trade-off in hiking the dose in terms of increased side effects, said Teva.
Separately, Alcon has filed a patent infringement complaint in a US district court against Teva in response to the Israeli firm's filing for approval to sell a generic version of Alcon's Vigamox (moxifloxacin), which is used to treat eye infections.
Alcon said it licenses the product from Bayer, and that the two companies jointly filed suit against Teva.