8 July 2016
Vernalis Announces Successful Completion of CCP-08 Pivotal
Multiple-Dose Comparative Bioavailability Study
CCP-08 NDA filing remains on track for 2016
Vernalis plc ("Vernalis" or the "Company") today announces successful completion of the CCP-08 pivotal multiple-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. The second product, CCP-07, completed its pivotal multi-dose comparative bioavailability study in April 2016.
CCP-08 continues in 12-month stability studies and subject to the successful outcome of these studies, filing of the NDA 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 to report the successful completion of the CCP-08 pivotal bioavailability studies and look forward to further news flow from this programme and others in our prescription long-acting cough cold product pipeline later in 2016. We remain excited by the potential for our emerging franchise in the US following the launch of the first product, Tuzistra® XR, last year."
This announcement contains inside information.
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Notes to Editors
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.
For further information about Vernalis, please visit 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 NCE pipeline, the Company's ability to successfully commercialise its cough-cold products and Moxatag® through its own sales force, 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 Tuzistra® XR, Moxatag®, 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.