On February 2, 2016 Array BioPharma Inc. (NASDAQ: ARRY) reported results for the second quarter ending December 31, 2015 of its fiscal year and provided an update on the progress of its key clinical development programs (Filing, 8-K, Array BioPharma, FEB 2, 2016, View Source [SID:1234508933]).
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Ron Squarer, Chief Executive Officer of Array, noted, "We were excited this quarter to share positive results from the first global Phase 3 trial of binimetinib in patients in NRAS-mutant melanoma. We plan to submit these results to regulators during 2016. In addition, we continue to make important progress with binimetinib and encorafenib in several other clinical trials, and expect to announce top-line results from COLUMBUS in BRAF-mutant melanoma in 2016."
KEY PIPELINE UPDATES
Binimetinib (MEK162) and encorafenib (LGX818)
NEMO meets primary endpoint; regulatory filing expected in 1H 2016
COLUMBUS top-line results expected in 1H 2016; regulatory filing expected in 2H 2016
New Phase 3 global registration trial in BRAF-mutant colorectal cancer expected to start in 2016
Update on Phase 3 trials
In December 2015, Array reported top-line results from the ongoing Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment, with a hazard ratio of 0.62, [95% CI 0.47-0.80] and a p-value of less than 0.001. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm. In the trial, binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients.
Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Results from the NEMO trial including progression free survival, overall survival, objective response rate, safety and prespecified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical conference in 2016.
In addition, Array expects top-line results from Part 1 of the COLUMBUS trial in the first half of 2016 and projects a regulatory filing of binimetinib and encorafenib in 2016. In October 2015, Part 2 of COLUMBUS achieved its target patient enrollment. The MILO Phase 3 study in patients with low-grade serous ovarian cancer continues to enroll patients, and Array estimates enrollment to be complete in 2016 with the availability of top-line data, along with a projected regulatory filing, in 2017.
Based on the strength of the Phase 2 combination data with encorafenib in patients with BRAF-mutant colorectal cancer shared at the 2015 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)’s (ESMO) (Free ESMO Whitepaper) World Congress of Gastrointestinal Cancer, Array plans to initiate a Phase 3 global registration trial in that patient population in 2016.
Collaboration with Pierre Fabre
In November 2015, Array and Pierre Fabre announced a collaboration agreement for binimetinib and encorafenib. Under the terms of the agreement, Array received an upfront payment of $30 million in January 2016 and retains exclusive commercialization rights for binimetinib and encorafenib in key territories, including the United States and Japan. Pierre Fabre will have exclusive rights to commercialize both products in other territories, including Europe, Asia and Latin America. Array is entitled to receive up to $425 million if certain development and commercialization milestones are achieved, and is eligible for robust, tiered double-digit royalties. Array and Pierre Fabre have agreed to split future development costs on a 60:40 basis (Array:Pierre Fabre) with initial funding committed for new clinical trials in colorectal cancer and melanoma. The agreement was reviewed and approved by the European Commission on Competition in December 2015. All currently active binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis.
Pierre Fabre Oncology, a business unit of the global 10,000-employee Pierre Fabre company, is supported by over 1,000 employees with a strong focus on European markets. In 2014, worldwide annual sales of Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral Navelbine, Javlor and Busilvex brands. In addition, Pierre Fabre has a significant commitment and track record in pharmaceutical R&D, developing products for patients afflicted with lung, breast and other solid tumors and hematological cancers.
ARRY-797 (ARRY-371797) – Phase 2 trial on-going in patients with LMNA A/C-related dilated cardiomyopathy (DCM)
Array is conducting a 12-patient Phase 2 study to evaluate the effectiveness and safety of ARRY-797 in patients with LMNA A/C-related DCM, a serious, genetic cardiovascular disease. By age 45, approximately 70% of patients with LMNA A/C-related DCM will have died, suffered a major cardiac event, or will have undergone a heart transplant. Data on the primary endpoint of mean change in 6-minute walk test (6MWT) at 12 weeks relative to baseline exceeds benchmarks set by a number of drugs for rare diseases recently approved on the basis of the 6MWT as a primary endpoint. Secondary endpoints, including changes in N-Terminal pro-Brain-derived Natriuretic Peptide (NT-proBNP, a serum biomarker of heart failure severity), and patient reported outcomes, are directionally consistent with the primary endpoint. Enrollment in this trial is complete. Data for patients followed through 48 weeks supports the durability of effect. Taken together, the data to date suggest a path forward for this program. Results with additional patient follow-up will be presented at an appropriate medical conference in 2016.
Selumetinib (partnered with AstraZeneca) – Three registration trials advancing in NSCLC (SELECT-1), thyroid cancer (ASTRA) and neurofibromatosis type 1
AstraZeneca continues to advance selumetinib in three registration trials: SELECT-1 in patients with KRAS-mutant non-small cell lung cancer, a registration trial in patients with neurofibromatosis type 1 and ASTRA in patients with differentiated thyroid cancer. AstraZeneca expects to share top-line results from SELECT-1 in mid-2016.
FINANCIAL HIGHLIGHTS
Cash, cash equivalents, marketable securities and accounts receivable totaled $185.4 million at the end of the quarter. Accounts receivable primarily consist of receivables expected to be paid by Novartis within three months and the $30.0 million license fee from Pierre Fabre, which was received in January 2016. In March 2015, binimetinib and encorafenib became wholly-owned assets, which prompted changes to the classification of revenue and expenses for the programs. The new expense classifications were included in the fourth quarter of fiscal 2015 financial results and, beginning in the first quarter of fiscal 2016, Array reports revenue from Novartis reimbursements under its agreements with Novartis for binimetinib and encorfenib as a separate line item called "reimbursement revenue."
Second Quarter of Fiscal 2016 Compared to First Quarter of Fiscal 2016 (Sequential Quarters Comparison)
Revenue for the second quarter of fiscal 2016 was $35.4 million, compared to $16.2 million for the prior sequential quarter. The $19.2 million increase in revenue was primarily due to higher reimbursement revenue from Novartis. Cost of partnered programs for the second quarter of fiscal 2016 was $5.7 million, compared to $6.2 million for the prior quarter. Research and development expense was $41.4 million, compared to $21.0 million in the prior quarter. The increase in research and development expense is primarily related to the ongoing transition of binimetinib and encorafenib trials from Novartis to Array. Net loss for the second quarter was $24.2 million, or ($0.17) per share, and was $21.0 million, or ($0.15) per share in the prior quarter.
Second Quarter of Fiscal 2016 Compared to Second Quarter of Fiscal 2015 (Prior Year Comparison)
Compared to the same quarter of fiscal 2015, revenue for the second quarter of fiscal 2016 increased $8.5 million primarily due to $27.3 million in reimbursement revenue from Novartis. Cost of partnered programs decreased $7.4 million compared to the second quarter of fiscal 2015 primarily due to binimetinib development costs being presented as research and development expense instead of cost of partnered programs upon becoming wholly-owned programs. Research and development expense increased $29.5 million compared to the second quarter of fiscal 2015 due to the categorization of binimetinib costs, as well as new spending on encorafenib. Net loss for the second quarter of fiscal 2016 was $24.2 million, or ($0.17) per share, and was $8.6 million, or ($0.06) per share, for the same quarter in fiscal 2015.
Six Months of Fiscal 2016 Compared to Six Months of Fiscal 2015 (Prior Year Comparison)
For the six months ended December 31, 2015, revenue was $51.6 million, compared to $33.0 million for the same period in fiscal 2015. Net loss for the six months ended December 31, 2015, was $45.2 million, or ($0.32) per share, compared to a net loss of $36.2 million, or ($0.27) per share, in the comparable prior year period.