Summary

• Page properties (1 modified, 0 added, 0 removed)

Details

Page properties

Content

...	...	@@ -2,13 +2,13 @@
2	2	{{toc/}}
3	3	{{/box}}
4	4
5		-= =
	5	+= Overview =
6	6
7	7	Array (ARRY) is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies. Eight registration studies are currently advancing related to seven Array-owned or partnered drugs: binimetinib (MEK162), encorafenib (LGX818), selumetinib (partnered with AstraZeneca), danoprevir (partnered with Roche), ipatasertib (partnered with Genentech), larotrectinib (partnered with Loxo Oncology) and tucatinib (partnered with Cascadian Therapeutics).
8	8
9	9	The company have received a total of $1.0 billion in research funding and in up-front and milestone payments from partners from inception through June 30, 2017 , including $292.0 million in initial payments from strategic agreements that The company entered into over the last ten years. The company received an up-front cash payment of $85.0 million upon the March 2015 effective date of the asset transfer agreement with Novartis for binimetinib, $30.0 million in January 2016 from Pierre Fabre and $31.2 million in June 2017 from Ono. Its existing partnered programs entitle Array to receive a total of over $2.7 billion in additional milestone payments if The company or its partners achieve the drug discovery, development and commercialization objectives detailed in those agreements. The company also have the potential to earn royalties on any resulting product sales or share in the proceeds from licensing or commercialization from 17 partnered clinical and discovery programs. The potential milestones The company are entitled to receive are further described in Note 5 – Collaboration and Other Agreements to its financial statements included elsewhere in this Annual Report on Form 10-K.
10	10
11		-//Binimetinib and Encorafenib//
	11	+== //Binimetinib and Encorafenib// ==
12	12
13	13	In March 2015, The company regained development and commercialization rights to binimetinib, a MEK inhibitor, under the Termination and Asset Transfer Agreement with Novartis Pharma AG and Novartis Pharmaceutical Ltd. and acquired development and commercialization rights to encorafenib, a BRAF inhibitor, under the Asset Transfer Agreement with Novartis Pharma AG (which the company collectively refer to as the “Novartis Agreements”). The company believe these programs present significant opportunity to Array in the area of oncology.
14	14
...	...	@@ -30,11 +30,11 @@
30	30
31	31	Binimetinib and encorafenib are currently being studied in Phase 3 trials in advanced cancer patients, including the COLUMBUS trial studying encorafenib in combination with binimetinib in patients with BRAF-mutant melanoma and the BEACON CRC trial (Binimetinib, Encorafenib and Cetuximab Combined to treat BRAF-mutant CRC) to study encorafenib in combination with binimetinib and cetuximab in patients with BRAF V600E-mutant CRC (or "BRAFm CRC"). Binimetinib and encorafenib are investigational medicines and are not currently approved in any country.
32	32
33		-COLUMBUS
	33	+== COLUMBUS ==
34	34
35	35	The company continue to advance the Phase 3 COLUMBUS trial, which compares binimetinib and encorafenib versus vemurafenib in BRAF-mutant melanoma patients. As part of this trial, Array submitted two NDAs to the FDA to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (or "COMBO450") for the treatment of patients with BRAF -mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study, whicth showed that patients who received binimetinib and encorafenib had a significantly longer progression free survival (or "PFS") compared to patients receiving vemurafenib. Array’s European partner, Pierre Fabre, remains on track to file the Marketing Authorization Applications for binimetininb and encorafenib during the summer 2017.
36	36
37		-BEACON
	37	+== BEACON ==
38	38
39	39	The company is advancing the BEACON CRC trial, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF -mutant colorectal cancer (or "CRC") who have previously received first- or second-line systemic therapy. In May 2017, Array announced that based on an attractive safety profile and with early encouraging clinical activity observed in the safety lead-in, the randomized portion of the trial continues to enroll patients. Data from the safety lead-in will be presented at the ESMO Congress in September 2017 in Madrid, Spain. The presentation will include objective response rate, duration of exposure, durability of response and details on adverse event reporting.
40	40
...	...	@@ -50,11 +50,11 @@
50	50
51	51	The company initiated an inflammation collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. The undisclosed target and lead inhibitors were discovered using Array's proprietary Kinase-Directed Phenotypic Screening Platform that leverages its deep expertise in chemistry and early lead development. Under the terms of the agreement, Amgen and Array will collaborate on preclinical development with Array leading the medicinal chemistry work. Amgen is responsible for clinical development and commercialization. In exchange for exclusive rights to its preclinical program, Amgen will make upfront and milestone payments, as well as pay royalties on sales of resulting therapies.
52	52
53		-**RECENT DEVELOPMENTS**
	53	+= **Recent Developments** =
54	54
55	55	On August 7, 2017, The company entered into an amendment to the convertible promissory notes issued to Redmile Biopharma Investments I, L.P. and Redmile Capital Offshore Fund II, Ltd. pursuant to which the maturity date of each of the notes was extended to August 6, 2018 and the exit fee payable upon cash repayment of each of the notes was increased to an amount equal to 50% , or $5.0 million of the principal amount under each of the notes.
56	56
57		-**Business Development and Partner Concentrations**
	57	+== **Business Development and Partner Concentrations** ==
58	58
59	59	The company currently license or partner certain of its compounds and/or programs and enter into collaborations directly with pharmaceutical and biotechnology companies through opportunities identified by its business development group, senior management, scientists and customer referrals. In general, The company's partners may terminate their agreements with it with 60 to 180 days' prior notice. Specifics regarding termination provisions under its material collaboration or license agreements can be found in Note 5 – Collaboration and Other Agreements to the accompanying audited financial statements included elsewhere in this Annual Report on Form 10-K.
60	60