FDA, Clinical Trial Binary Events: Amarin, Amicus, Labopharm

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Includes: AMRN, ENDP, FOLD
by: Mike Havrilla

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

Amarin Corp. (NASDAQ:AMRN) has a conference call scheduled for Tuesday 10-August at 11am ((NYSE:ET)) and plans to provide an update on its financials and a progress update on the two ongoing pivotal Phase 3 studies (MARINE and ANCHOR) for AMR101 as a purified, prescription-grade omega-3 fatty acid compound that is being evaluated for the treatment of high triglycerides.

The MARINE study was last updated on 9-June in the ClinicalTrials.gov database (study ID= NCT01047683) to reflect that the trial is ongoing, but no longer recruiting participants; so AMRN may announce the study is fully randomized on the update call next week since both studies are designed with a 6-8 week run-in period prior to the 12-week randomized treatment phase. Once fully randomized, top-line results could be expected within 4-5 months, reflecting the 12-week treatment period and time required for statistical analysis prior to data release.

Amicus Therapeutics (NASDAQ:FOLD) expects to complete enrollment for its pivotal US trial (Study 011) of AMIGAL (migalastat HCl) for the treatment of Fabry disease by year-end 2010 and report results mid-2011. In addition, FOLD expects to begin a pivotal Phase 3 EU trial (Study 012) and Phase 2 enzyme replacement therapy co-administration study by year-end 2010.

Labopharm (NASDAQ:DDSS) has an upcoming 2Q10 financial results and quarterly update conference call scheduled for Thursday 12-August at 830am (ET) with a press release expected at 7A (ET) that day for potential update on its New Drug Submission (NDS) status for OLEPTRO (once-daily formulation of trazodone). The Health Canada action date was 8/4/10 for an expected regulatory approval decision for OLEPTRO as an anti-depressant, and the drug was approved by the FDA earlier this year in February with an expected US market launch this quarter and ongoing marketing / sales partnership discussions.


Disclosure: Long AMRN