Summary

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

Details

Page properties

Content

...	...	@@ -10,7 +10,7 @@
10	10
11	11	[[image:https://www.sec.gov/Archives/edgar/data/1576263/000162828018002942/miratipipelinea01.jpg]]
12	12
13		-==== Sitravatinib ====
	13	+== Sitravatinib ==
14	14
15	15	//Sitravatinib in Combination with Immune Checkpoint Inhibitors//
16	16
...	...	@@ -38,7 +38,7 @@
38	38
39	39	Under the BeiGene Agreement, BeiGene agreed to pay to Mirati an upfront fee of $10.0 million. BeiGene is also required to make milestone payments to Mirati of up to an aggregate of $123.0 million upon the first achievement of specified clinical, regulatory and sales milestones. Additionally, BeiGene is obligated to pay to Mirati royalties at tiered percentage rates ranging from mid-single digits to twenty percent on annual net sales of licensed products in the Licensed Territory, subject to reduction under specified circumstances.
40	40
41		-==== Mocetinostat ====
	41	+== Mocetinostat ==
42	42
43	43	**Background**
44	44
...	...	@@ -50,7 +50,7 @@
50	50
51	51	In October 2017, the company announced that mocetinostat has been included in the SU2C Catalyst® program, a cutting-edge research initiative led by Stand up to Cancer (“SU2C”) designed to bring innovative cancer treatments to patients quickly through novel collaborations between industry and academia. The Phase 1/1b clinical trial, sponsored by Memorial Sloan Kettering Cancer Center, is designed to evaluate the potential of epigenetic agents to improve patient responses to immunotherapy in NSCLC which will combine mocetinostat, guadecitabine, a DNA methyltransferase inhibitor from Astex Pharmaceuticals, Inc., and pembrolizumab, a PD-1 checkpoint inhibitor from Merck & Co., Inc. (known as MSD outside the United States and Canada). The clinical trial enrolled its first patient in August 2017.
52	52
53		-==== KRAS G12C Inhibitor Program ====
	53	+== KRAS G12C Inhibitor Program ==
54	54
55	55	**Background**
56	56
...	...	@@ -64,7 +64,7 @@
64	64
65	65	In November 2017, the company announced that, in light of superior investment opportunities in its pipeline, the company suspended further investment in glesatinib and will pursue opportunities to partner the program.
66	66
67		-==== Market and Competition ====
	67	+= Market and Competition =
68	68
69	69	**Market**
70	70
...	...	@@ -93,7 +93,7 @@
93	93	|Tagrisso|423
94	94	|Alecensa|186
95	95
96		-==== Competition ====
	96	+= Competition =
97	97
98	98	**Sitravatinib in Combination with Immune Checkpoint Inhibitors**
99	99
...	...	@@ -121,7 +121,7 @@
121	121
122	122	Many companies have filed, and continue to file, patent applications which may or could affect its program if and when they issue, either because they protect a product that may compete with its product candidates, or because they protect intellectual property rights that are necessary for it to develop and commercialize its product candidates. These companies include, but are not limited to: Bristol-Myers Squibb, Exelixis, GlaxoSmithKline, Novartis and Pfizer. Since this area is competitive and of strong interest to pharmaceutical and biotechnology companies, the company expect that these and other companies will continue to publish and file patent applications in this space in the future, as well as pursuing research and development programs in this area. The company continue to monitor these and other companies in order to be aware of any third-party products and/or intellectual property rights relevant to its product candidates.
123	123
124		-==== Intellectual Property ====
	124	+= Intellectual Property =
125	125
126	126	The company's goal is to obtain, maintain and enforce patent protection wherever appropriate for its product candidates, formulations, processes, methods and any other proprietary technologies both in the United States and in other countries. The company typically file for patents in the United States with counterparts in certain countries in Europe and certain key market countries in the rest of the world, thereby covering the major pharmaceutical markets. As of December 31, 2017, the company own or co-own U.S. patents and patent applications and their foreign counterparts, including 28 issued U.S. patents as reflected in the following table:
127	127
...	...	@@ -131,13 +131,13 @@
131	131	|KRAS inhibitors|0|3|2036-2037
132	132	|Total|28|3|'
133	133
134		-==== Manufacturing ====
	134	+= Manufacturing =
135	135
136	136	The company do not own or operate manufacturing facilities for the production of any of its product candidates, nor do the company plan to develop its own manufacturing operations in the foreseeable future. The company currently depend on third-party contract manufacturers for all of its required raw materials and finished products for its preclinical and clinical trials.
137	137
138	138	Manufacturers of its products are required to comply with applicable FDA manufacturing requirements contained in the FDA's Current Good Manufacturing Practices (“cGMP”) regulations. cGMP regulations require, among other things, quality control and quality assurance as well as corresponding maintenance of records and documentation. Pharmaceutical product manufacturers and other entities involved in the manufacture and distribution of approved pharmaceutical products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer or holder of an approved new drug applications ("NDA"), including withdrawal of the product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented.
139	139
140		-==== Liquidity Overview ====
	140	+= Liquidity Overview =
141	141
142	142	At March 31, 2018, the company had $148.7 million of cash, cash equivalents and short-term investments compared to $150.8 million at December 31, 2017. In January 2018 the company received an upfront fee of $10.0 million in connection with the BeiGene Agreement. Mirati Therapeutics has not generated any revenue from product sales. To date, Mirati Therapeutics has funded its operations primarily through the sale of its common stock and pre-funded warrants to purchase its common stock and through up-front payments, research funding and milestone payments under collaborative arrangements. To fund future operations, the company will likely need to raise additional capital.
143	143