15 September 2014
LSE: VER

 

Vernalis plc and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for TuzistraTM XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015.

Under the exclusive licensing agreement announced in February 2012, Tris is developing, on behalf of Vernalis, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. TuzistraTM XR represents the first product within this pipeline to reach NDA stage. The financial terms of this licensing deal are not disclosed.

Ian Garland, CEO of Vernalis commented "Today's announcement is in line with our target timelines and importantly TuzistraTM XR remains on-track for potential launch ahead of the 2015-16 cough cold season".

Ketan Mehta, CEO of Tris commented, "FDA's acceptance of this NDA submission provides further momentum to our collective cough/cold strategy, with a focus on improving patient care".

 

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Enquiries:

Vernalis plc:

 

Ian Garland, Chief Executive Officer

+44 (0) 118 938 0015

David Mackney, Chief Financial Officer

 

Tris Pharma, Inc.:

+1 732 940 2800 x104

Peter Ciano, SVP, Strategy and Corporate Development

 

Canaccord Genuity Limited (Nominated Adviser):

+44 (0) 20 7523 8350

Lucy Tilley

 

Dr Julian Feneley

 

Henry Fitzgerald-O’Connor

 

Shore Capital (Joint Broker)

+44 (0)20 7408 4090

Bidhi Bhoma

 

Toby Gibbs

 

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

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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AGM Statement

Vernalis plc ("Vernalis" or the "Company") provides an update ahead of its Annual General Meeting ("AGM") being held today at 10.30 am at the offices of Covington & Burling, 265 Strand, London WC2R 1BH. 

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F: 0118 938 0001

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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