Biotech Values

[DewDiligence]

Teva completes enrollment of GALA phase-3 trial for thrice-weekly Copaxone:

http://finance.yahoo.com/news/Teva-Completes-Enrollment-in-bw-1437582157.html?x=0&.v=1

This international Phase III trial in patients with relapsing-remitting multiple sclerosis (RRMS), is designed to examine the efficacy, safety and tolerability of 40mg COPAXONE administered three times a week compared to placebo. The primary endpoint of the trial is the total number of confirmed relapses during a 12-month placebo-controlled phase, which will be followed by an open-label extension phase [this is significant—see discussion below].

Patient enrollment was completed in May 2011, recruiting over 1,400 patients at 180 sites in the United States, Europe, Central Eastern Europe and Israel. Results from the trial are expected in the second quarter of 2012.

Teva is once again being disingenuous, IMO. Copaxone dosed at 40mg thrice weekly will almost certainly be efficacious, but it may not be as safe as ordinary daily Copaxone dosed at 20mg. Hence, the FDA will probably not entertain an NDA for thrice-weekly Copaxone until all of the safety data are in hand.

Although data for the primary efficacy endpoint will be available in 2012, as noted in Teva’s PR above, the open-label safety portion of the study is expected to run until May 2014 (http://clinicaltrials.gov/ct2/show/NCT01067521 ). Thus, thrice-weekly Copaxone probably won’t reach the US market until 2015 at the earliest.

Note: Teva discontinued development of daily 40mg Copaxone in 2008 when it failed to show superiority to regular Copaxone (#msg-30498483).