CCP-08 NDA filing remains on track for 2016
Vernalis plc (“Vernalis” or the “Company”) today announces successful completion of the CCP-08 pivotal single-dose comparative bioavailability study.
CCP-08 is the third extended-release product being developed for Vernalis by Tris Pharma Inc. (“Tris”) for the US prescription cough-cold market. The first product, Tuzistra® XR was approved by the FDA in April 2015 and was launched by Vernalis in September 2015, through a focused US primary care sales force.
CCP-08 will now move into a multiple-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-08 with the FDA, remains on track for 2016.
Under the licensing and development collaboration announced on 10 February 2012, Vernalis is paying Tris to develop up to six unique extended-release equivalents to existing immediate-release prescription cough-cold treatments.
Ian Garland, CEO of Vernalis commented “We are delighted with the continued progress of CCP-08 and look forward to further news flow from this programme during 2016".
Enquiries:
Vernalis plc:
+44 (0) 118 938 0015
Ian Garland, Chief Executive Officer
David Mackney, Chief Financial Officer
Canaccord Genuity Limited (Nominated Adviser):
+44 (0) 20 7523 8000
Dr Julian Feneley
Henry Fitzgerald-O’Connor
Emma Gabriel
Shore Capital (Joint Broker):
+44 (0)20 7408 4090
Bidhi Bhoma
Toby Gibbs
FTI Consulting:
+44 (0) 20 3727 1000
Ben Atwell
Simon Conway
Stephanie Cuthbert
About Vernalis
Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has three approved products: Tuzistra® XR targeting the US prescription cough-cold market; Moxatag®, a once-a-day formulation of the antibiotic, amoxicillin, indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older; and frovatriptan for the acute treatment of migraine. It has an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough-cold market as well as eight 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 Asahi Kasei Pharma, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier, Taisho, and Tris.
