Vernalis PLC FDA Issues Complete Response Letter on CCP-08 NDA (2148N)
August 07 2017 - 1:00AM
UK Regulatory
TIDMVER
RNS Number : 2148N
Vernalis PLC
07 August 2017
07 August 2017
LSE: VER
FDA Issues a Complete Response Letter on CCP-08 NDA
Vernalis plc announced today that the US Food and Drug
Administration (FDA) has issued a Complete Response Letter (CRL)
regarding the New Drug Application (NDA) for CCP-08.
A CRL is issued by the FDA when it has completed its review of
an NDA and questions remain that preclude its approval at this
time. This CRL indicated that the outstanding items which resulted
in the CRL for CCP-07 remain and that they need to be addressed
prior to the resubmission and approval of both NDAs.
"Unfortunately, the outstanding items that resulted in a CRL for
CCP-07 could not be addressed in time to avoid the same outcome for
CCP-08. The approval of both CCP-08 and CCP-07 are of the utmost
importance to Vernalis, and we are working closely with our partner
Tris and the FDA to resubmit both NDAs as quickly as possible,"
said Ian Garland, CEO of Vernalis plc. "We look forward to
providing additional updates on our progress with this in the
coming months."
The information contained within this announcement is deemed to
constitute inside information as stipulated under the Market Abuse
Regulations (EU) No. 596/2014. Upon the publication of this
announcement this inside information is now considered to be in the
public domain.
-- 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 and Joint Broker): 8000
Henry Fitzgerald-O'Connor
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
Stern Investor Relations, Inc: + 1 212 362 1200
Stephanie Ascher
Carl Mauch
Notes to Editors
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-daily 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 focused 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 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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