Data showed 72% of patients treated with Mozobil and G-CSF achieved the target threshold for collection of at least 6M CD34+cells/kg from the peripheral blood with 2 days or fewer of apheresis sessions compared to 34% in the placebo group 8/07; submitted marketing applications in the U.S. and Europe 6/08

Phase III showed 59% of patients treated with Mozobil in combination with standard-of-care granulocyte-colony stimulating factor achieved the target threshold for collection of at least 5M CD34+cells/kg from the peripheral blood, compared with 20% of patients in the G-CSF and placebo group 7/07; won FDA approval to ease stem cell collections in patients in need of transplants 12/08

Began pivotal trial to evaluate safety and efficacy with cytarabine in up to 376 patients 9/06; filed an sNDA to use Clolar in adult patients with AML 11/08

Starting Phase II/III trial following positive efficacy data from 50 patients in Phase II trial 5/06; IDSMB recommended continuation of a Phase II/III trial after a planned interim analysis of safety data 12/06; data showed increase in overall survival 12/06; data showed that patients receiving TNFerade plus standard of care had a 25% lower risk of death than those receiving the standard of care alone 11/08

A randomized, Phase III trial of chemotherapy with or without Genasense failed to meet its primary endpoint of overall survival 12/06

Data resulted in a 14% positive biopsy rate in men with a PCA3 score of less than 5, compared to a 69% positive biopsy rate in patients with a PCA3 score greater than 100 3/08

Met the primary endpoint in a Phase III trial 7/08

Began pivotal Phase III trial to evaluate drug in 100 patients with refractory B-cell CLL 5/06

Monitors in Phase III trial identified no safety concerns and recommended continuing without modification 6/06; monitors found no safety concerns 10/06; a data monitoring committee met for the final time and identified no safety concerns with the Phase III studies; completed enrollment in its final Phase III study 3/07; reported positive results from two additional Phase III trials 4/07; Phase III data statistically significant improvement vs. oral iron on the primary endpoint 7/07

Phase III ATLAS I and ATLAS II trials demonstrated better rates of cure than vancomycin 8/06; additional data demonstrated non-inferiority to vancomycin 10/06; filed for FDA approval 12/06; FDA accepted the NDA 2/07; Phase III data showed that the telavancin-treated patients had higher clinical cure, bacterial eradication and overall response rates than those given vancomycin 9/07; FDA issued an approvable letter 10/07; FDA found the company's response to an approvable letter complete for an

Began Phase III trial comparing drug to vancomycin 1/05

Submitted an NDA 2/08; FDA accepted the NDA 4/08; submitted an MAA; EMEA accepted it for review 6/08; FDA issued a complete response letter, asking for another study 12/08; received a complete response letter indicating that it needs another study 12/08

Was granted approvals in the UK, Denmark, Germany, Belgium, the Netherlands, Luxembourg, Finland and Sweden, as well as in Spain, under the name Sitamic 6/08

Phase III data showed that 171 of 553 total patients in both the treatment and control groups responded to treatment after 48 weeks 2/08; all 553 patients completed a Phase III trial 6/08

A second Phase III trial failed to show improved virologic response with pegylated interferon alpha vs. that agent alone 5/06; completed enrollment in a Phase III trial of drug in combination with pegylated interferon alpha and ribavirin 12/06; data showed it failed to achieve statistical significance 11/08

Received an approvable letter from the FDA 5/08

Completed enrollment in Phase III trial in Mexico, Guatemala, India and Peru 5/03; began Phase III in Mexico 7/05; Phase III trial in 210 patients who had traveled to Mexico showed statistically significant prevention of the condition 1/06

Started a Phase III trial 03/08

Phase III data was stopped while the company considers removing the Ketek arm due to risks that outweigh the benefits 12/06