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DewDiligence

07/17/12 1:51 PM

#145580 RE: genisi #138127

Active Biotech pushes ahead with Laquinimod in the EU, despite the drug’s regulatory shortcomings in the US (#msg-72323524):

http://finance.yahoo.com/news/active-biotech-announce-european-medicines-064100075.html
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DewDiligence

08/08/12 10:59 AM

#146737 RE: genisi #138127

Teva plows ahead with new phase-3 Laquinimod study:

http://www.sec.gov/Archives/edgar/data/818686/000130901412000483/exhibit1.htm

TEVA TO INITIATE THIRD PHASE III TRIAL OF ORAL LAQUINIMOD FOR THE TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS

The clinical trial protocol has been granted a Special Protocol Assessment agreement by the Food and Drug Administration

…The third Phase III laquinimod trial CONCERTO will evaluate two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).

Laquinimod may not be dead but, in all likelihood, it will remain a day late and a dollar short.