Started an international Phase III trial 8/08

Filed an NDA 11/07; FDA refused to file the NDA 1/08

Completed enrollment in the first pivotal Phase III trial; trial ended with no serious adverse events attributed to the drug following 12 months of treatment 8/08; enrolled the first subject in its second Phase III trial 9/08

Company reached the recruitment target of 354 subjects in its Phase III trial 2/07; all patients completed the efficacy phase of its global Phase III 7/07; Phase III trial showed it improved quality of life and mucus clearance; reached an agreement with the FDA on an SPA for a Phase III trial 6/08

Began Phase III trial to identify exercise-induced broncho-constriction 12/05; filed for approval in Switzerland 7/06; received approval in Germany 5/08

FDA's Reproductive Health Drugs Advisory Committee voted 9 to 3 that Fablyn's benefits outweigh its risks in certain populations, but the panel could not come to a consensus on which population the drug should be used 9/08

Phase III trial showed a trend toward improvement but did not achieve statistical significance for primary endpoint of treatment success 8/06

Company is entering Phase III after positive Phase II data 10/07; completed patient enrollment in its Phase III trial 12/08

Began Phase III trial to evaluate safety and efficacy in 900 patients over three years 10/05

Trial did not demonstrate statistical significance vs. placebo in the primary endpoint of time to removal of immobilization; one secondary endpoint was met, but others were not 3/06; Data showed that a subset of female osteopenic subjects treated with 10 mcg of drug demonstrated a statistically significant benefit 2/07

FDA said humanitarian device exemption for use in hand reconstruction and donor sites in EB patients was approvable pending inspection of manufacturing facility 9/06

Submitted first of two modules of PMA 12/03; met endpoints 2/04; FDA requested confirmatory trial 4/05

Missed statistical significance in a Phase III trial 12/06; began submission of a rolling NDA to treat patients with late-stage liver cirrhosis 5/08

Data from Phase III trial showed significant advantages in weight loss and the drug outperformed either naltrexone or bupropion given alone 9/06; moved Contrave into the second of four Phase III studies 5/07

Started a Phase III trial 7/07; first patient was dosed in a Phase III trial 8/07; completed enrollment of a Phase III trial 12/08; Opko is ending its Phase III trial after a data monitoring committee determined the study was unlikely to meet its primary endpoint 3/09

Partner FFE Enterprises Inc. is starting a Phase III trial 8/06

Began a Phase III program 6/08; data showed treatment with a single dose significantly improved symptom scores and significantly reduced prostrate size after 90 days 10/08; data showed statistically significant improvements in urinary symptoms 10/08; of patients receiving a full single dose, 76.7% required no further treatment compared to 37.5% of patients in the control arm, which was statistically significant 11/08

Phase III data showed it failed to meet its endpoint; only 25% showed a trend that did not reach statistical significance 10/07; a Phase III extension study showed both doses were safe and generally well tolerated 3/08; Phase III data showed it was generally well tolerated and effective, with lower dose findings showing statistical significance 5/08; extension data showed it reduced patients' dependence parenteral nutrition 10/08; patient enrollment has begun in a Phase III study 12/08

FDA said product was approvable but needed another trial 7/05