Vernalis Announces Successful Pivotal Single Dose Bioavailability Study with First Cough Cold Product, CCP-01

25 November 2013

LSE: VER

 

 

Vernalis plc today announces successful completion of the CCP-01 Pivotal Single Dose comparative bioavailability study.

CCP-01 is the first product being developed for Vernalis by Tris Pharma for the US prescription cough cold market.  It will now move into a multi-dose comparative bioavailability study and continues in 12 month stability studies.  Subject to the successful outcome of these studies, filing of the NDA for CCP-01 with the FDA remains on track to be made in mid-2014.

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 are not disclosed.

Ian Garland, CEO of Vernalis commented “We are delighted with these results and the continued progression of this project and our collaboration with Tris”.

 

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Enquiries:

 

Vernalis Contacts:

Ian Garland, Chief Executive Officer

+44 (0) 118 938 0015

David Mackney, Chief Financial Officer

 

Oriel Securities Limited:

+44 (0)20 7710 7600

Juliet Thompson

 

Jonathan Senior

Brunswick Group:

+44 (0) 20 7404 5959

Jon Coles

 

Notes to Editors

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 Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier and Tris.

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.

Latest News

Vernalis plc receives a $2 million milestone payment from one of its drug discovery collaborations

Vernalis plc announced today that it has received a $2m milestone under one of its existing research collaborations to discover novel small molecules against an undisclosed target utilising Vernalis' fragment and structure-based drug discovery platform.

 

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To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and drugsafety@propharmagroup.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch