News

← News

Published on September 15, 2014

FDA accepts Tuzistra™ XR (CCP-01) NDA for full review

MONMOUTH JUNCTION, N.J., September 15, 2014; -

Vernalis plc and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015.

Under the exclusive licensing agreement announced in February 2012, Tris is developing, on behalf of Vernalis, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. Tuzistra XR represents the first product within this pipeline to reach NDA stage. The financial terms of this licensing deal are not disclosed.

Ian Garland, CEO of Vernalis commented "Today’s announcement is in line with our target timelines and importantly Tuzistra XR remains on-track for potential launch ahead of the 2015-16 cough cold season."

Ketan Mehta, CEO of Tris commented, "FDA's acceptance of this NDA submission provides further momentum to our collective cough/cold strategy, with a focus on improving patient care."

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, USA. For more information, please visit http://www.trispharma.com

About Vernalis:

Vernalis is a revenue generating development stage pharmaceutical company with significant expertise in drug development. The Group has one marketed product, frovatriptan for the acute treatment of migraine, an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough cold market as well as seven programmes in its NCE development pipeline. Vernalis has also significant expertise in fragment and structure based drug discovery which it leverages to enter into collaborations with larger pharmaceutical companies. The Company’s technologies, capabilities and products have been endorsed over the last five years by collaborations with leading pharmaceutical companies, including AKP, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier and Tris.

For further information about Vernalis, please visit http://www.vernalis.com.

Vernalis Forward-Looking Statement

This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.