The experimental therapy, ONO-4641, is in the second of three stages of clinical trials usually required for regulatory approval, Merck said in a statement today. The companies will also collaborate in Japan on the development and marketing of Merck’s Stimuvax, a cancer treatment in the final stage of trials, according to the statement.
ONO-4641 is Darmstadt, Germany-based Merck’s second attempt to develop a tablet for MS after it decided not to seek approval of its cladribine pill in June. Novartis’s Gilenya, the first oral drug for MS, was approved last year and Israel’s Teva Pharmaceutical Industries Ltd. (TEVA) is developing a competing laquinimod pill.
“There’s a huge unmet clinical need,” said Gustav Ando, a London-based analyst at consulting company IHS Global Insight. With a pill, “the patient doesn’t have to go to the hospital for monthly injections, which significantly impedes quality of life.”
Novartis has 13,000 patients on Gilenya, the Basel, Switzerland-based company said in July. The drug may reach $1.2 billion in sales by 2013 and $2.1 billion by 2015, according to analysts’ estimates compiled by Bloomberg.
“It’s a very lucrative market,” Ando said.
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