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First Product in Tris Pharma’s Collaboration with Vernalis Achieves Proof-of-Concept, Triggering Milestone Payment to Tris

MONMOUTH JUNCTION, N.J., March 11, 2013 — Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, announced today receipt of a first milestone payment under its U.S. prescription cough/cold collaboration with Vernalis plc (Vernalis). This milestone recognizes the achievement by Tris of proof-of-concept (POC) for the first collaboration compound, CCP-01.

Under the collaboration, POC required the successful completion of several activities, including a successful human pilot comparative study against an immediate release reference product. Assuming continued clinical success, Tris expects to file a New Drug Application with the U.S. Food & Drug Administration for CCP-01 in mid-2014.

“We’re very pleased to have achieved proof-of-concept for CCP-01,” said Ketan Mehta, President and CEO of Tris Pharma. “Our propriety OralXR+™ technology is ideally suited to bring long-lasting relief to U.S. cough and cold sufferers, which our research has identified as a significant unmet need.”

Ian Garland, CEO of Vernalis, commented, “We are delighted with this early success in our collaboration with Tris and look forward to a productive 2013 when we anticipate further significant progress for our cough/cold pipeline.”

Under the deal announced in February 2012, Vernalis is paying Tris to develop up to six unique OralXR+ based extended-release liquid equivalents to existing immediate release prescription cough/cold treatments. The companies have not disclosed the financial terms of their collaboration.

About Tris Pharma:

Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, U.S.A. For more information, please visit https://www.trispharma.com

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2031 US Highway 130
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