- Phase 1 dose escalation trial for the new formulation of ARRY-614 in patients with myelodysplastic syndromes
- Phase 2 combination trial for ARRY-520 plus dexamethasone in patients with multiple myeloma who are refractory to Revlimid® (lenalidomide), Velcade® (bortezomib) and dexamethasone therapy
- Phase 1b combination trial for ARRY-520 plus Velcade in patients with relapsed or refractory multiple myeloma
- Phase 2a trial for ARRY-502 in patients with persistent asthma
- Phase 2a trial for AMG151 trial in patients with Type 2 diabetes
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.
In this trial, ARRY-797 was considered overall to be well-tolerated at the selected dose of 400 mg twice-daily. The most common adverse events observed in patients treated with ARRY-797 were dizziness, diarrhea and nausea, which were mainly mild in severity. ARRY-797 treatment was associated with sporadic, transient increases in creatine kinase and aspartate aminotransferase. Mild prolongations of the QTc interval and sustained decreases in systolic and diastolic blood pressure were also observed. Given the scope of a development program in pain, Array will seek an appropriate partner to maximize the value of this drug.ARRY-614 – Dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS): Array advanced ARRY-614 in a Phase 1 clinical trial in patients with MDS using an optimized formulation of the drug with improved plasma exposure and lower inter-subject variability. Array intends to meet with the FDA to discuss the development plan to support registration. ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array advanced ARRY-520 in three clinical trials: 1. Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid, Velcade and dexamethasone therapy 2. Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM 3. Phase 1b investigator-sponsored trial in combination with Kyprolis® (carfilzomib) in patients with relapsed or refractory MM who are refractory or intolerant to Velcade therapy Positive results in any one of these trials could define a path to late stage development. ARRY-502 – CRTh2 antagonist for asthma: Array continued a Phase 2a trial with ARRY-502, a CRTh2 antagonist, in patients with persistent asthma. Array expects top-line results from this trial during the second quarter of calendar 2013 and intends to seek a partner for further development of ARRY-502 in this large- market disease indication. Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer: Results for selumetinib in patients with KRAS mutation-positive NSCLC were presented in June 2012 at the American Society of Clinical Oncology (ASCO) annual meeting. This double-blind, randomized Phase 2 study showed statistically significant improvement in progression-free survival, objective response rate, and alive and progression-free at six months as well as longer median overall survival of 9.4 versus 5.2 months in favor of selumetinib in combination with docetaxel versus docetaxel alone. In addition, AstraZeneca initiated a bioequivalence trial comparing the current Phase 2 and planned Phase 3 capsule formulations. And Array expects results to be reported this year for the Phase 2 trial with selumetinib in combination with dacarbazine versus dacarbazine alone as first-line treatment in patients with BRAF-mutant melanoma. MEK162 (Novartis) – MEK inhibitor for cancer: Novartis and Array are currently conducting eleven clinical trials, including two Phase 2 trials, three Phase 1b trials in combination with different PI3 kinase inhibitors, two Phase 1b trials in combination with different RAF inhibitors and one Phase 1b trial in combination with paclitaxel. Promising data on MEK162 in an ongoing Phase 2 trial of patients with BRAF and NRAS mutated advanced melanoma were presented at the ASCO annual meeting. In this trial, MEK162 showed clinical activity and good tolerability in patients with BRAF or NRAS melanoma. This is the first targeted therapy to show activity in patients with NRAS mutated melanoma. OTHER DEVELOPMENTS
- In July, Array received an $8.5 million milestone in its collaboration on AMG 151 with Amgen Inc. The milestone was achieved after Amgen reached a pre-defined patient enrollment level in a Phase 2a clinical trial in patients with Type 2 diabetes.
- At the 2012 ASCO annual meeting, Genentech, a member of the Roche Group, presented results from a Phase 1b dose escalation trial showing that GDC-0068, an AKT inhibitor invented by Array scientists, was well-tolerated, when combined with Taxotere or mFOLFOX6, up to the single-agent maximum tolerated dose. Both combinations show evidence of clinical benefit, including in patients with PI3K/Akt pathway alterations and with prior taxanes or platinum agent treatment.
- In April, Genentech initiated a Phase 1 trial with GDC-0575, a Chk-1 inhibitor Array licensed to Genentech, to evaluate multiple ascending-doses alone and in combination with Gemzar® (gemcitabine).
|Date:||Tuesday, August 14, 2012|
|Time:||9:00 a.m. eastern time|
|Array BioPharma Inc.|
|Condensed Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended June 30,||Twelve Months Ended June 30,|
|License and milestone revenue||$||17,622||$||15,595||$||71,249||$||53,426|
|Cost of revenue||6,259||7,635||24,261||28,916|
|Research and development for proprietary|
|General and administrative||4,473||4,292||15,202||16,261|
|Total operating expenses||25,609||31,206||96,182||108,675|
|Gain (Loss) from operations||(4,945||)||(12,160||)||(11,047||)||(36,774||)|
|Other income (expense)|
|Realized gains (losses) on auction rate securities, net||-||-||-||1,891|
|Total other expense, net||(3,080||)||(9,592||)||(12,534||)||(19,550||)|
|Weighted average shares outstanding -|
|basic and diluted||90,897||56,991||70,619||55,447|
|Net loss per share - basic and diluted||$||(0.09||)||$||(0.38||)||$||(0.33||)||$||(1.02||)|
|Summary Balance Sheet Data|
|June 30,||June 30,|
|Cash, cash equivalents and marketable securities||$||89,650||$||64,708|
|Property, plant and equipment, gross||$||86,287||$||85,968|
|Long-term debt, net||$||92,256||$||91,540|