Two-year Phase III study shows Novartis oral MS therapy FTY720 significantly reduces relapses and disability progression.

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FREEDOMS study shows FTY720 reduced relapse rates by 54-60% compared to placebo, and disability progression by 30-32%[1]

Results build on Phase III TRANSFORMS one-year study showing FTY720 reduced relapses significantly more than interferon beta-1a, a standard of care[2]

Phase III efficacy and safety data confirm positive benefit-risk profile for lower 0.5 mg dose[1] and support planned submissions in US and EU at end of 2009

Future development of FTY720 in relapsing forms of MS to focus on lower 0.5 mg dose

Basel, September 30, 2009 - Initial results from the two-year Phase III FREEDOMS study show that oral FTY720 (fingolimod) was significantly superior to placebo in reducing both relapses and disability progression in patients with relapsing-remitting multiple sclerosis (MS)[1] - one of the leading causes of neurological disability in young adults[3].

The FREEDOMS study met its primary and secondary endpoints for both the 0.5 mg and 1.25 mg doses, with no significant difference in efficacy between doses. This result builds on previous data showing superior efficacy to interferon beta-1a[2] in TRANSFORMS, the largest head-to-head Phase III study against a standard of care treatment in MS.

In FREEDOMS, …