Ron Squarer, Chief Executive Officer of Array, noted, “We made great progress from a financial standpoint in fiscal 2012. We recorded a double-digit increase in annual revenue while managing our spending and strengthening our cash position. Looking ahead, we are evolving into a late-stage development company, moving towards multiple pivotal trials by the end of calendar year 2013.”
Mr. Squarer added, “We are excited about the recently announced Phase 2 clinical trial results for ARRY-797 which showed statistically significant pain reduction on top of NSAIDS compared to placebo plus NSAIDs in osteoarthritis patients suffering from moderate to severe knee pain. Remarkably, for patients who completed the trial, the level of pain relief demonstrated by ARRY-797, a non-opioid drug, was comparable with oxycodone ER, a proven, powerful opioid with significant tolerability and safety issues. The drop-out rate for oxycodone ER was more than five times greater than for ARRY-797. In addition, we remain confident that AstraZeneca and Novartis will continue development of selumetinib and MEK162, respectively, based on the potential these products hold for patients as demonstrated in their Phase 2 trials shared at ASCO.”
UPDATES ON KEY PROGRAMS
ARRY-797 – p38 inhibitor for pain: Array announced in July 2012 that ARRY-797, a non-opioid, met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase 2 clinical trial in 157 osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). Patients in all treatment groups continued using NSAIDs throughout the trial. ARRY-797 is a novel, oral, selective p38 inhibitor with a mechanism of action unique from that of currently approved pain medications.Treatment with ARRY-797 resulted in a statistically significant reduction in pain over a 28-day period compared to placebo, as measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) pain subscale (a 0 – 10 numerical pain rating scale). Patients receiving ARRY-797 experienced a mean reduction in the WOMAC pain subscale score at day 28 vs. baseline that was 0.8 greater than those receiving placebo (2.4 vs. 1.6; one-sided p = 0.0247). Oxycodone ER was used as the active control for the trial and achieved improvement of 0.28 versus Placebo due to a higher discontinuation rate. ARRY-797 also showed improvement relative to placebo or oxycodone ER in additional measures including, WOMAC physical function, WOMAC stiffness and the Patient’s Treatment Satisfaction Measure. The discontinuation rate due to adverse events was higher in patients treated with oxycodone ER (34%) than for either the ARRY-797 (6%) or placebo (8%) treatment groups. In patients completing the trial, the reduction in WOMAC pain observed for ARRY-797 was comparable to that seen with oxycodone ER.