Published on February 01, 2014
Vernalis Announces Successful Completion of Second Pivotal Bioavailability Study with First Cough Cold Product, CCP-01
Vernalis plc today announces successful completion of the second and final CCP-01 pivotal comparative bioavailability study. This positive multi-dose study follows successful completion of the single dose study announced in November last year.
CCP-01 is the first product being developed for Vernalis by Tris Pharma for the US prescription cough cold market. Both pivotal comparative bioavailability studies required to support an NDA filing in mid-2014 have now been completed successfully. In addition to these studies, the NDA will be supported by data from a 12-month stability programme for which positive interim 6-month stability data has already been generated.
Under the deal announced in February 2012, Vernalis is paying Tris Pharma to develop up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. The financial terms of this licensing deal have not been disclosed.
Ian Garland, CEO of Vernalis commented “We are delighted with these further positive results that complete the critical clinical component of the mid-2014 NDA filing. We look forward to completion of the on-going stability study and the filing of our first NDA from our collaboration with Tris”.
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 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.
About Tris Pharma:
Tris Pharma is an emerging specialty pharmaceutical company focused on the research and development of drug delivery technologies based products. Through its OralXR+ platform, 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™ platform 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