levodopa/carbidopa CR (DM 1992) / Assertio - LARVOL DELTA

5 Pharmaceutical companies with insider buying during August 14-16 (SeekingAlpha) - Depomed expects to have the results for its P2 trial in Parkinson's disease with DM-1992 before Q4 2012

Anticipated P2 data • Parkinson's Disease

Study in advanced Parkinson's disease patients with predictable motor fluctuations (clinicaltrials.gov) - P2, N=34; Sponsor: Depomed; Active, not recruiting -> Completed

Trial completion • Parkinson's Disease

Depomed announces initiation of phase 2 clinical study in Parkinson's disease (Depomed) - Depomed has initiated a P2 clinical trial of DM-1992, Depomed's novel gastric-retentive, extended-release formulation of carbidopa/levodopa, in patients with advanced Parkinson's disease with motor fluctuations; The P2 clinical trial is designed to enroll at 8 U.S. clinical centers up to 45 pts with Parkinson's disease with motor fluctuations; The study will assess efficacy, safety & pharmacokinetic variables

Initiation of P2 trial • Pipeline shift P1 -> P2 • Parkinson's Disease

A crossover study of DM-1992, a gastroretentive formulation of carbidopa/levodopa in PD patients with motor fluctuations (ANA 2013) - Abstract #M1242; P2, N=34; Sponsor: Depomed; NCT01515410; "Mean (SD) daily %OFF time at baseline was 32.5% (10) and at day 10, 27.2% (18.2) with DM-1992 vs 33.5% (12.7) with IR-CD/LD (p50.047). Patients with baseline LD 1000 mg/day (n523) benefited more from DM-1992 than all patients with 21.62 hrs OFF time and 12 hrs ON time vs IR-CD/LD. There was no AE pattern and no discontinuations due to AEs. Twice-daily DM-1992 reduced OFF time significantly more than IR-CD/LD dosed 3–8 times/day."

P2 data • Parkinson's Disease

Depomed reports top line data for phase 2 study in Parkinson's disease (Depomed) - P2, N=34; "The primary endpoint for the study is change in percent "off" time during waking hours, as measured by patient self-assessment during the treatment period relative to the baseline period. Patients' mean baseline "off" time during waking hours was 5.4 hours per day (32.5%), compared to 4.5 hours (27.2%) during the DM-1992 self-assessment period and 5.5 hours (33.5%) for the IR CD/LD comparator. The reduction in percent "off" time reported during the DM-1992 patient self-assessment period relative to the IR CD/LD comparator was statistically significant"

P2 data • Parkinson's Disease