Profile: Insys Therapeutics Inc (INSY.OQ)
11 Dec 2013
Insys Therapeutics, Inc., incorporated on June 15, 1990, is a pharmaceutical company that develops and seeks to commercialize pharmaceutical products that target the unmet needs of cancer patients, with an initial focus on cancer-supportive care. The Company’s pharmaceuticals portfolio consists of one approved product and a number of product candidates targeting cancer-supportive care and cancer therapy. The Company’s product candidate includes Subsys, Dronabinol SG Capsule, Dronabinol RT Capsule, Dronabinol Oral Solution, Dronabinol Inhalation Device, and Dronabinol IV Solution. The Company is also developing cancer therapeutics, which is LEP-ETU, a formulation of paclitaxel, the active ingredient in the cancer drugs Taxol and Abraxane. On August 19, 2011, the Food & Drug Administration (FDA) approved its Dronabinol SG Capsule product, a generic equivalent to Marinol, for the treatment of chemotherapy induced nausea and vomiting (CINV), and anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS).
The Company's Subsys is a single-use product that delivers fentanyl, an opioid analgesic, in seconds for transmucosal absorption underneath the tongue. Subsys is a transmucosal product to show pain relief when measuring the sum of pain intensity difference at five minutes in a Phase 3 breakthrough cancer pain (BTCP) clinical trial using fentanyl.
Dronabinol Product Family
The Company has an approved dronabinol product and is developing several dronabinol product candidates for the treatment of CINV and appetite stimulation in patients with AIDS, as well as other indications where dronabinol could have potential therapeutic benefits. Dronabinol, the active ingredient in Marinol, is a synthetic cannabinoid whose chemical name is delta-9-tetrahydrocannabinol (THC). Its portfolio consists of its Dronabinol SG Capsule product and Dronabinol RT Capsule product candidate, which are intended to be generic equivalents to Marinol, in addition to three formulations, including Dronabinol Oral Solution. Dronabinol SG Capsule is a dronabinol soft gelatin capsule intended to be a generic equivalent to Marinol. Dronabinol RT Capsule is a dronabinol soft gel capsule that is stable at room temperature. Dronabinol Oral Solution is a ynthetic THC in an oral liquid formulation.
In addition to its cancer-supportive care products, the Company intends to develop cancer therapeutics targeting limitations of existing commercial products. LEP-ETU, it advanced cancer therapeutic, is a NeoLipid liposomal, or microscopic membrane-like structure created from lipids, formulation that incorporates paclitaxel. LEP-ETU completed a Phase 2 clinical trial of 70 patients with metastatic breast cancer.
The Company competes with Cephalon, Inc., BioDelivery Sciences International, Inc., ProStrakan Group plc, Nycomed International Management GmbH, Archimedes Pharma Ltd., TEVA Pharmaceuticals USA, Watson Pharmaceuticals, Inc., AcelRx Pharmaceuticals, Inc., Akela Pharma Inc., Abbott Laboratories, Pharmaceutical International, Inc., Par Pharmaceutical Companies Inc., sanofi-aventis, Eisai Inc., Helsinn Group, Roche Holding AG, Par Pharmaceutical Companies Inc., GlaxoSmithKline plc, ProStrakan Group plc, Merck & Co, GW Pharmaceutical, A.P. Pharma, Inc., Aphios Corp., Roche Holding, Tesaro, Inc., Cornerstone Pharmaceutical, Inc., Bristol-Myers Squibb, Celgene Corporation, Laboratories, Amgen Inc., AstraZeneca PLC., Bayer AG, Biogen Idec Inc., Eisai Co., Ltd., F. Hoffmann- LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Onyx Pharmaceuticals Inc., Pfizer Inc., and Takeda Pharmaceutical Co. Ltd.
Insys Therapeutics Inc
444 South Ellis Street
PHOENIX AZ 85044