Insys Therapeutics, Inc. (NASDAQ:INSY) Files An 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On June 2, 2019, each of Steven Meyer and Pierre Lapalme notified Insys Therapeutics, Inc. (the “Company”) that he will resign from the board of directors (the “Board”) of the Company, effective upon the execution of the agreements relating to the settlement with the U.S. Department of Justice (the “DOJ”), as described in Item 8.01 below. Each of Mr. Meyer’s and Mr. Lapalme’s decision to resign is not due to any disagreements relating to the Company’s operations, policies or practices. In connection with Mr. Meyer’s resignation, the Board elected John McKenna to serve as a member of the Audit Committee, effective immediately following Mr. Meyer’s resignation.
Item 8.01 Other Events.
On June 5, 2019, the Company entered into a settlement with the United States formalizing its previously announced settlement relating to certain civil statutory claims by the United States to the False Claims Act. As part of this agreement, the Company agreed to pay $195 million on a schedule agreed to by the parties.
On June 5, 2019, the Company also entered into a criminal Deferred Prosecution Agreement with the United States Attorney for the District of Massachusetts concerning five counts of mail fraud. In connection with the same investigation, on June 5, 2019, Insys Pharma, Inc., a wholly owned subsidiary of the Company (“Insys Pharma”), entered into a plea agreement with the United States Attorney for the District of Massachusetts, whereby Insys Pharma agreed to plead guilty to five counts of mail fraud. As part of this plea agreement, Insys Pharma agreed with the United States to recommend a sentence including $30 million in fines and forfeiture to be paid on a schedule agreed to by the parties.
On June 5, 2019, the Company also entered into a Corporate Integrity Agreement and Conditional Exclusion Release with the Office of the Inspector General of the Department of Health and Human Services relating to the previously reported investigations.
About Insys Therapeutics, Inc. (NASDAQ:INSY)
Insys Therapeutics, Inc. is a commercial-stage specialty pharmaceutical company. The Company develops and commercializes supportive care products. The Company’s product Subsys, is a sublingual fentanyl spray for breakthrough cancer pain (BTCP) in opioid-tolerant patients and a single-use product that delivers fentanyl, an opioid analgesic, for transmucosal absorption underneath the tongue. The Company markets Subsys through its field sales force focused on supportive care physicians in the United States. Subsys delivers a liquid fentanyl formulation in approximately 100, 200, 400, 600, 800, 1,200 and 1,600 micrograms (mcg) dosages. The Company’s lead dronabinol product candidate is Syndros, which is under review for approval at the Food and Drug Administration. In addition, the Company is evaluating sublingual spray, inhaled and intravenous formulations of dronabinol in preclinical studies.
