Vernalis PLC FDA accepts CCP-07 NDA for full review (0103J)
September 06 2016 - 2:00AM
UK Regulatory
TIDMVER
RNS Number : 0103J
Vernalis PLC
06 September 2016
6 September 2016
LSE: VER
FDA accepts CCP-07 NDA for full review
PDUFA date of 20 April 2017
Vernalis plc and Tris Pharma, Inc. ("Tris") are pleased to
announce that the U.S. Food and Drug Administration ("FDA") has
accepted the CCP-07 New Drug Application ("NDA") 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 20 April 2017.
Under the exclusive licensing and collaboration agreement
announced in February 2012, Tris is developing up to six unique
extended release equivalents to existing immediate release
prescription cough cold treatments for the US market. CCP-07 is the
second product from this pipeline to be accepted for full NDA
review. The first product, Tuzistra(R) XR, was approved by the FDA
in April 2015 and was launched by Vernalis in September 2015 by a
dedicated sales force.
Ian Garland, CEO of Vernalis, commented "Today's announcement
confirms CCP-07 is on track for potential launch ahead of the
2017-18 cough cold season and we remain extremely excited about the
commercial prospects of this cough cold franchise".
Ketan Mehta, CEO of Tris, commented "This is our second NDA for
Vernalis and Tris is excited with the continued progress and look
forward to an expanded cough/cold commercial footprint."
This announcement contains inside information.
-- ends --
Enquiries:
+44 (0) 118 938
Vernalis plc: 0015
Ian Garland, Chief Executive
Officer
David Mackney, Chief Financial
Officer
Canaccord Genuity Limited (Nominated +44 (0) 20 7523
Adviser): 8000
Dr Julian Feneley
Henry Fitzgerald-O'Connor
Rupert Winckler
Emma Gabriel
+44 (0)20 7408
Shore Capital (Joint Broker): 4090
Bidhi Bhoma
Toby Gibbs
+44 (0) 20 3727
FTI Consulting: 1000
Ben Atwell
Simon Conway
Stephanie Cuthbert
Notes to Editors
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(TM) 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.
About Vernalis
Vernalis is a revenue generating, commercial stage
pharmaceutical company with significant expertise in drug
development. The Group has three approved products: Tuzistra(R) XR
targeting the US prescription cough-cold market; Moxatag(R) , 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(R) 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(R) XR, Moxatag(R) ,
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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