Egalet Corporation (NASDAQ:EGLT) Files An 8-K Other Events

ME Staff 8-k
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Egalet Corporation (NASDAQ:EGLT) Files An 8-K Other Events
Item 8.01 — Other Events.

As Egalet Corporation (the “Company”) has disclosed previously, the Company is a party to an agreement with Apotex Corp. and Apotex Inc. (collectively, “Apotex”) that permits the potential launch of an authorized generic for SPRIX Nasal Spray in March2018. Under the Company’s agreement with Apotex, Apotex was required to inform the Company in writing on or before November25, 2017 (the “Notification Deadline”) that it was exercising its option for an authorized generic product to be launched on March25, 2018. The Company did not receive any such written notification on or before the Notification Deadline; therefore, Apotex has lost the right to launch an authorized generic version of SPRIX Nasal Spray. If Apotex is able to satisfy the requirements for launching an unauthorized generic, including securing approval of its abbreviated new drug application by the U.S. Food and Drug Administration, it would be permitted to do so in September2018, and, in certain circumstances, six months prior to that date, whereupon it would be obligated to pay the Company royalties on net sales of such generic version from the launch date until December2018.


About Egalet Corporation (NASDAQ:EGLT)

Egalet Corporation is a specialty pharmaceutical company. The Company is engaged in developing, manufacturing and commercializing treatments for pain and other conditions. The Company’s products include OXAYDO and SPRIX Nasal Spray. The Company is developing two late-stage product candidates, ARYMO ER and Egalet-002 using Guardian Technology. The Company’s product SPRIX Nasal Spray, which contains ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) indicated in adult patients for the short-term management of moderate to moderately severe pain that requires analgesia at the opioid level. The Company’s product OXAYDO is an approved immediate-release (IR) oxycodone product formulated to deter abuse through snorting. The Company’s product candidate, ARYMO ER is an abuse-deterrent (AD), extended-release (ER), oral morphine formulation. The Company’s product candidate, Egalet-002, is an abuse-deterrent, extended-release, oral oxycodone formulation.