Swiss drugmaker, Novartis, has reported the first long-term clinical data in support of its oral drug for multiple sclerosis, FTY720, saying that it continued to show benefits in preventing relapses in patients with MS over 12 months. The data, from a Phase II study of the drug, also showed that FTY720 was well tolerated over the year, and Novartis said it is now consulting with regulatory authorities about protocols for a Phase III trial programme which should get underway by the end of 2005.
Novartis has high hopes for FTY720, which is on track to become the first alternative to injectable drugs in the treatment of MS, currently represented by the beta interferons (sold by Schering AG/Berlex, Serono and Biogen Idec) and Teva’s Copaxone (glatiramer acetate) now that Biogen Idec’s Tysabri (natalizumab) has been taken off the market [[01/03/05a]]. FTY720 is also in trials to prevent organ rejection in transplant patients.
Last year, Datamonitor predicted that the advent of oral MS drugs would expand the market for treatments for the disease from $2.8 billion dollars in 2003 to more than $6 billion in 2012. Analysts have suggested that FTY720 could rack up sales in excess of $1 billion dollars if it shows efficacy at least as good as its injectable rivals.
The 12-month data - presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Thessalonika on Saturday - showed that patient groups taking FTY720 who had experienced a reduction in their annualised relapse rate of more than 50% over the first six months compared to placebo, maintained this low relapse rate during the following six months. Moreover, in patients who switched from placebo in the first six months to Novartis’ drug, the annualised relapse rate was reduced by at least 70%.
Other companies developing oral drugs for MS include Serono with its Mylinax (cladribine) candidate in Phase III trials [[12/01/05d]], Sanofi-Aventis with teriflunomide (Phase III), GlaxoSmithKline and Tanabe with 683699 (Phase II) and Teva with an oral version of Copaxone (Phase II) and laquinimod (Phase II), licensed from Sweden’s Active Biotech.