Indications -- Psoriasis/Chronic Inflammation Message Board

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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation

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From: Icebrg	5/3/2007 5:06:46 AM
	of 631

Laquinimod data presented at scientific meeting (AAN) Active Biotech (SEK79.75 - Neutral) Sector: Health Care (Positive) [Source: Swedish investment bank Carnegie] Yesterday, Active Biotech and its partner Teva presented data at the Meeting of the American Academy of Neurology (AAN), confirming the positive outcome of the Phase IIb study on laquinimod (multiple sclerosis). We expect Phase III trials to start in H2(07). Data from this study, which was announced in September 2006 and carried out for 36 weeks on approximately 300 patients, showed significant reduction of accumulation of active lesions (damaged areas) in the brain. The laquinimod 0.6 mg dose showed a reduction compared with placebo in the cumulative number of enhancing lesions per scan. However, treatment with the 0.3 mg dose showed no significant difference. Both doses showed a positive safety profile. Reduction of active lesions is used as a surrogate endpoint in early studies of MS, as the true endpoint – reduction of disease-related relapses – takes at least two years to detect. The Phase II data on laquinimod indicated a reduction in disease-related relapses, but the Phase III trials will provide crucial data on the candidate drug's true efficacy. Phase III will be conducted for at least two years, but the first data will be evaluated in H1(08) – after one year. Phase III trials are now scheduled to start in H2(07) rather than in H1(07) as had been previously announced. The delay is due to Teva still being in discussions with the regulatory authorities regarding the set-up of the Phase III trials and not to any clinical setbacks. Several of Active Biotech's other clinical project are making good progress. However, laquinimod still accounts for more than 70% of the SOTP value. We reiterate out NEUTRAL rating.

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