Biotech Values

[DewDiligence]

(AGN)—Ipsen intends to submit DNG, a premixed formulation of Dysport, for regulatory approval in the EU, Latin America, the Middle East, and Asia (except Japan and China) despite the fact that DNG failed to show statsig non-inferiority to regular Dysport in a phase-3 trial in cervical dystonia:

http://finance.yahoo.com/news/ipsen-announces-clinical-results-dysport-060000988.html

When compared to Dysport, DNG did not demonstrate the statistical non-inferiority in efficacy at week 4 (adjusted mean reduction of 12.5 with DNG versus 14.0 with Dysport in TWSTRS total score). This efficacy difference is unlikely to be of clinical relevance [really?]. After repeated dose, DNG showed comparable efficacy to that of Dysport® as observed in former Phase III studies.

Botox, Dysport, and other currently marketed botulinum toxins require reconstitution prior to use.