Drug Pipeline Series: Phase III Oct23-Oct30, 2006

NICOX REPORTS RESULTS FROM OSTEOARTHRITIS TRIAL
NicOx has announced results from a successful Phase III trial for naproxcinod (HCT 3012) in patients with osteoarthritis of the knee (the 301 study). Both doses of naproxcinod were shown to be superior to placebo on all three co-primary efficacy endpoints of the study. Blood pressure data for both naproxcinod doses showed a sustained reduction versus baseline and naproxen at all time points, confirming earlier published clinical data. Naproxcinod is the first compound in the COX-inhibiting nitric oxide-donating class.
In terms of the co-primary endpoints of the study, both of the naproxcinod doses (375 and 750 mg) were shown to be superior to placebo, with this being highly statistically significant in terms of the mean change from baseline at week 13 in the following scores: the WOMAC pain subscale, the WOMAC function subscale and patients' overall rating of disease status.
During the trial, patients' blood pressure was measured at each visit. Prespecified analyses of the difference between the blood pressure at baseline and the measurements at week two, six and 13, demonstrated that both naproxcinod 750 and 375 mg decreased systolic and diastolic blood pressure. This effect was sustained until the 13-week time point and clearly differentiated naproxcinod from naproxen.
Naproxcinod also showed good overall safety: 46.7 percent of the patients treated with naproxcinod 750 mg and 40.8 percent on naproxcinod 375 mg experienced at least one adverse event, compared to 56.4 percent on naproxen 500 mg and 38.7 percent on placebo. The number of serious adverse events was low and evenly spread among treatment groups. The number of adverse hypotensive events was low across all groups.

Titan Initiates Phase III Development Program for Probuphine® in the Treatment of Opioid Dependence
Titan Pharmaceuticals, Inc. announced the initiation of a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study of Probuphine in the treatment of opioid dependence. The 150 patient study will evaluate the safety and effectiveness of treatment with Probuphine versus placebo in reducing opioid dependence over 24 weeks of treatment. This study is part of a registration directed program intended to obtain marketing approval of Probuphine for the treatment of opioid addiction in Europe and the U.S. The Phase III program includes additional clinical studies scheduled to begin in the first half of next year.
Probuphine is designed to provide continuous, long-term therapeutic levels of the drug buprenorphine, an approved agent for the treatment of opioid dependence. The Company believes that Probuphine has the potential to reduce limitations currently associated with daily oral buprenorphine therapy, including poor compliance, variable blood levels, morning withdrawal symptoms before each daily dose, and misdirection of drug.