Array BioPharma Inc. (NASDAQ: ARRY) today reported results for the first quarter of its fiscal year ending June 30, 2013.
Array continues its evolution into a late-stage development company, with five products approaching Phase 3 decisions by the end of calendar year 2013. These include two wholly-owned programs: ARRY-614 and ARRY-520, and three partnered programs: selumetinib (with AstraZeneca), MEK162 (with Novartis) and danoprevir (with InterMune/Roche).
Array reported revenue of $15.8 million for the first quarter of fiscal 2013, compared to revenue of $22.1 million for the same period in fiscal 2012. The decrease in first quarter revenue was expected, as Array recognized the majority of its $28 million upfront payment from a license agreement with Genentech during the previous fiscal year. The Company recorded expenses of $13.5 million on proprietary research and development for the quarter to advance its clinical development and discovery programs, compared to $12.6 million during the same period last year. Net loss for the first quarter was $11.8 million, or ($0.13) per share, compared to $3.6 million, or ($0.06) per share, for the same period last year. Array ended the first quarter of fiscal 2013 with $68 million in cash, cash equivalents, and marketable securities.
Ron Squarer, Chief Executive Officer of Array, noted, "This promises to be an important year for Array as several drugs in our wholly-owned and partnered pipelines move towards commercialization. We are on track to advance ARRY-520 for multiple myeloma and ARRY-614 for myelodysplastic syndromes into late-stage development in the coming year. Success with any of these programs will propel Array towards a self-sustaining biopharmaceutical company."
KEY PROGRAM UPDATES
ARRY-520 – KSP inhibitor for Multiple Myeloma (MM):
During the quarter, ARRY‑520, a potent, selective KSP inhibitor with a mechanism of action distinct from other drugs used to treat multiple myeloma, was advanced in three clinical trials. Positive results in any one of these trials will define a clear path to late stage development:
Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid® (lenalidomide), Velcade® (bortezomib) and dexamethasone therapy.
Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM.
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.
Three abstracts on ARRY-520 have been submitted, including a potential patient selection biomarker for presentation, at the 2012 American Society of Hematology (ASH) Annual Meeting in December 2012. ASH is the world's largest professional society concerned with the causes and treatments of blood disorders.
ARRY-614 – Dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS):
During the quarter, 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.
Array also submitted an abstract on ARRY-614 for presentation at the 2012 ASH Annual Meeting.
ARRY-797 – non-opioid p38 inhibitor for pain:
Array has submitted an abstract on the Phase 2 trial results with ARRY-797 in patients with osteoarthritis pain for "late-breaker" presentation at the 2012 ACR Annual Meeting. This abstract includes data on analgesic effect and potential disease modification based on markers of cartilage and bone degradation.
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. Given our internal focus on hematology/oncology, Array is in active discussions with potential partners to maximize the value of this drug.
MEK-162 – MEK inhibitor for Cancer (Novartis):
Novartis is hosting an R&D Investor Day on Thursday, November 8, 2012. An update on MEK162 will be provided at this meeting.
Selumetinib – MEK inhibitor for Cancer (AstraZeneca):
At the 2012 ESMO annual meeting, an update on the Phase 2 KRAS-mutant non-small cell lung cancer trial was presented. In a post-hoc analysis, more patients experienced clinically meaningful improvements in lung cancer symptoms with selumetinib plus docetaxel than docetaxel alone. In particular, the time to deterioration of the Lung Cancer Subscale (LCS) score was in favor of the combination with a hazard ratio of 0.33 (p=0.0002). As initially presented at the 2012 ASCO annual meeting, this was the first prospective study to demonstrate a clinical benefit of a targeted therapy for patients with KRAS-mutant cancer of any type.