Phase III trial in patients with osteoarthritis of the knee achieved statistical significance vs. placebo for the primary endpoint of pain intensity 4/06; Canadian regulators accepted marketing application for review 8/06; FDA issued approvable letter on NDA 9/06; submitted a complete response to the approvable letter 12/06; received a second approvable letter from the FDA, saying the company failed to demonstrate efficacy due to faulty statistical methodology 6/07; submitted a complete response

Completed patient enrollment for the pivotal Phase III trial 4/08

Began a Phase III trial to evaluate safety and efficacy vs. placebo 9/06

Dosed the first patient in a pivotal Phase III study 06/08

Began pivotal Phase III trial to evaluate drug in 256 patients with moderate to severe post-operative orthopedic pain 5/06

Received marketing authorization approval in the UK 10/07; completed patient enrollment in the second of two Phase III studies 9/08; data showed it provided statistically significant pain relief compared to placebo 12/08

Phase III data showed statistically significant results; ISTA plans to file a supplemental NDA 2/07; submitted an NDA 12/07

Reached agreement with the FDA on an SPA for a Phase III program 1/07; started its Phase III program, which will enroll 1,200 patients between two trials 3/07; began a Phase III study in patients at risk for gastric ulceration 10/07; completed enrollment of a target 1,500 patients in two Phase III trials 2/08; HZT-501 met all primary endpoints in two pivotal studies 12/08

Filed an NDA 10/07; FDA has accepted for review the company's NDA 7/08

Phase IIIb data showed positive results for the subcutaneous administration of morphine with Hylenex recombinant 2/07

Filed for approval under the decentralized procedure in the UK, Spain, Denmark and the Netherlands 9/06

Began Phase III trial in Europe and Canada to evaluate pain relief in multiple sclerosis patients 8/06; failed Phase III trial due to high placebo response 4/08

Health Canada approved a new indication for Sativex as an adjunctive analgesic treatment 8/07; began the first U.S. Phase II/III trial 11/07

FDA approved SynviscOne 12/08

Phase III data showed significantly improved symptoms of depresion compared to placebo in adolescents 5/08

Phase III data indicated patients had statistically significant benefits in cognition and clinical global status compared to placebo 2/08

Started the Phase II/III study 5/07

Phase III trial in Europe failed to demonstrate efficacy vs. placebo 9/06

Second Phase III trial corroborated positive findings in a prior efficacy study 5/06; Endo submitted supplemental NDA to the FDA seeking approval 7/06; FDA accepted supplemental NDA for filing 9/06; FDA said it would need three more months to review the supplemental NDA that was filed in August; no new data are needed; the review is expected to be completed by Aug. 19 3/07; Phase III data demonstrated that Frova significantly reduced the frequency and severity of MM as well as the disabilities