Second Product in Vernalis' Cough Cold Pipeline Achieves Proof-of-Concept
April 29, 2014 - Winnersh, United Kingdom
Vernalis plc (LSE: VER) (PINKSHEETS: VNLPY)
Vernalis plc and Tris Pharma, Inc. today announce the achievement of proof-of-concept (POC) for CCP-07, the second programme to achieve this milestone in their US prescription cough cold collaboration. Under this collaboration, POC requires the successful completion of several activities, including a successful human pilot comparative study against an immediate release reference product. Assuming continued success, an NDA for CCP-07 is expected to be filed in the second half of 2015. As a result of achieving POC, Vernalis will make a milestone payment to Tris.
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 financial terms of this licensing deal are not disclosed.
Ian Garland, CEO of Vernalis commented "CCP-07 is the second of five programmes currently in development under our collaboration with Tris to achieve proof-of-concept, with the most advanced, CCP-01, on-track for NDA filing in the middle of this year. We are delighted with the continuing progress of our pipeline of cough cold programmes and look forward to further successes over the remainder of 2014".
Ketan Mehta, CEO of Tris commented "Tris is excited with the continued progress of the prescription cough/cold portfolio. The products are a great application of our OralXR+ technology and will ultimately improve patient care".
Notes to Editors
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 www.vernalis.com
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 www.trispharma.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.
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