Egalet Corp

Egalet’s lead product candidate, Egalet-001, is an abuse-deterrent, extended-release, oral morphine formulation in development for the treatment of moderate to severe pain. There are currently no commercially available abuse-deterrent formulations of morphine, and the company believes that Egalet-001, if approved, would fill a significant unmet need in the marketplace.

The company has completed its Phase 1 clinical trials of Egalet-001 and it plans to initiate pivotal trials to establish the bioequivalence of Egalet-001 to MS-Contin®, a currently approved oral morphine formulation, in the first quarter of 2014 and submit a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, in the fourth quarter of 2014.

Its second product candidate, Egalet-002, is an abuse-deterrent, extended-release, oral oxycodone formulation in development for the treatment of moderate to severe pain. If approved, it will have advantages over commercially available, long-acting, abuse-deterrent oxycodone products due to its differentiated abuse-deterrent properties and a pharmacokinetic, or PK, profile that demonstrates low peak-to-trough concentration variability in drug exposure. The company has conducted Phase 1 trials of Egalet-002 and has completed initial abuse deterrence studies in compliance with the FDA draft guidance. It plans to initiate the first of two Phase 3 trials for Egalet-002 in the fourth quarter of 2014 and to submit an NDA to the FDA in the first half of 2016.

In November 2013, Egalet entered into a collaboration and license agreement with Shionogi Limited, or Shionogi, granting Shionogi an exclusive, royalty-bearing, worldwide license to develop, manufacture and commercialize abuse-deterrent hydrocodone-based product candidates using the company’s technology. Shionogi will be responsible for all expenses associated with the development of these product candidates and is responsible for the completion of all clinical trials necessary to support NDA filings for the product candidates. Under the terms of the agreement, Shionogi made an upfront payment to us of $10.0 million.