|By Marketwired .||
|June 30, 2014 02:32 AM EDT||
WINNERSH, UNITED KINGDOM -- (Marketwired) -- 06/30/14 -- Vernalis PLC (LSE: VER) (PINKSHEETS: VNLPY)
Submission of Tuzistra XR (CCP-01) NDA to FDA
Vernalis plc and Tris Pharma, Inc. ("Tris") are pleased to announce that a New Drug Application ("NDA") has been submitted to the U.S. Food and Drug Administration ("FDA") for Tuzistra XR ("CCP-01"), for the acute treatment of cough cold. The FDA has 60 days in which to confirm whether the NDA is accepted for full review, and on receipt of this confirmation a milestone payment to Tris is triggered.
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. CCP-01 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 "The submission of the Tuzistra XR NDA is a significant achievement in our collaboration with Tris. We are delighted with the continuing progress of our cough cold programmes and look forward to further successes over the remainder of the year."
Ketan Mehta, CEO of Tris commented, "Both our companies share a common vision and commitment of better serving cough cold patients. We look forward to several additional submissions over the next couple of years."
-- ends --
Vernalis plc: Ian Garland, Chief Executive Officer +44 (0) 118 938 0015 David Mackney, Chief Financial Officer Tris Pharma, Inc.: Peter Ciano, SVP, Strategy and Corporate Development +1 732-940-2800 x104 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
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.
For further information about Vernalis, please visit www.vernalis.com
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.
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the...
Sep. 28, 2016 10:00 AM EDT
Big Data has been changing the world. IoT fuels the further transformation recently. How are Big Data and IoT related? In his session at @BigDataExpo, Tony Shan, a renowned visionary and thought leader, will explore the interplay of Big Data and IoT. He will anatomize Big Data and IoT separately in terms of what, which, why, where, when, who, how and how much. He will then analyze the relationship between IoT and Big Data, specifically the drilldown of how the 4Vs of Big Data (Volume, Variety,...
Sep. 28, 2016 10:00 AM EDT Reads: 1,076
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Sep. 28, 2016 10:00 AM EDT Reads: 4,388
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
Sep. 28, 2016 10:00 AM EDT Reads: 2,205
Sep. 28, 2016 09:45 AM EDT Reads: 5,091
Sep. 28, 2016 09:15 AM EDT Reads: 1,062
Sep. 28, 2016 09:15 AM EDT Reads: 3,159
Sep. 28, 2016 09:00 AM EDT Reads: 1,277
Sep. 28, 2016 09:00 AM EDT Reads: 2,751
Sep. 28, 2016 09:00 AM EDT Reads: 3,842
Sep. 28, 2016 09:00 AM EDT Reads: 2,638
Sep. 28, 2016 08:45 AM EDT Reads: 2,549
Sep. 28, 2016 08:45 AM EDT Reads: 1,202
Sep. 28, 2016 08:45 AM EDT Reads: 1,128
Sep. 28, 2016 08:30 AM EDT Reads: 1,573