Biotech Values

[DewDiligence]

FDA approval of thrice-weekly Copaxone requires two post-marketing studies:

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020622Orig1s089ltr.pdf

Your deferred pediatric studies required by section 505B(a) of the FDCA are required postmarketing studies…. The required studies are listed below.

2114-1: A randomized, controlled, parallel group, superiority study in pediatric patients ages 10 through 17 years to evaluate the safety and efficacy of glatiramer acetate compared to an appropriate control for the treatment of relapsing forms of multiple sclerosis.

2114-2: A juvenile animal toxicology study in rats to evaluate the effects of glatiramer acetate on growth, reproductive development, and neurological and neurobehavioral development.

Teva has until 2021 to submit results from the first study and until 2017 to submit results from the second.