Biotech Values

[DewDiligence]

Teva reports Copaxone-in-CIS data from 5-year extension of the PreCISe study:

http://finance.yahoo.com/news/Early-Initiation-of-Treatment-bw-4151190818.html?x=0&.v=1

CIS (Clinically Isolated Syndrome) is considered a precursor of MS and is a modest but not insignificant market for Copaxone. The FDA approved Copaxone in CIS in Mar 2009 (#msg-36015642) based on data from the PreCISe study in which patients were followed for three years; the primary endpoint was time to “conversion” of CIS to full-fledged MS (http://clinicaltrials.gov/ct2/show/NCT00666224 ).

In the pivotal data, the primary-endpoint HR for Copaxone relative to placebo (with crossover after conversion) was 0.55 (p=0.0005); in the 5-year extension, the HR was 0.59 (p=0.0005). In other words, most of the treatment benefit of immediate Copaxone relative to placebo (plus delayed Copaxone) that was observed during the first three years was preserved out to five years.