Egalet Corp. received a $10 million milestone payment from Japanese pharmaceutical company Shionogi under terms of a licensing agreement the two organizations signed in 2013.
The payment was triggered by Shionogi filing an investigational new drug application with the Food and Drug Administration. The FDA filing was for an experimental hydrocodone‑based pain medicine, S-718632, that uses Egalet's proprietary Guardian technology for making abuse‑deterrent products.
Under the agreement Egalet (NASDAQ: EGLT) is eligible to receive total payments of more than $300 million, plus royalties, if multiple Shionogi product candidates that use the Guardian technology are approved.
Bob Radie, Egalet's president and chief executive officer, noted hydrocodone is the most frequently prescribed opioid in the United States and is associated with more drug abuse than any other opioid, according to the Drug Enforcement Agency.
Egalet's Guardian technology is used to create oral tablets, which provide for a controlled release of a drug's active pharmaceutical ingredient, encased in a shell designed to resist crushing. Drug abusers will crush a tablet into a powder so its can be snorted, smoked or further dissolved and injected.
The Wayne, Pa., company has two products in the market: Oxaydo, an oxycodone tablet, and Sprix, a pain medicine delivered as a nasal spray. Egalet also has a morphine product that uses its abuse-deterrent technology in late-stage clinical testing.