Share Name Share Symbol Market Type Share ISIN Share Description
Vernalis LSE:VER London Ordinary Share GB00B3Y5L754 ORD 1P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -0.375p -1.69% 21.75p 21.50p 22.00p 22.00p 21.25p 21.25p 1,125,910.00 15:30:30
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 12.0 -15.3 -3.2 - 114.45

Vernalis PLC FDA Issues Complete Response Letter on CCP-07 NDA

21/04/2017 7:00am

UK Regulatory (RNS & others)


Vernalis (LSE:VER)
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RNS Number : 9275C

Vernalis PLC

21 April 2017

21 April 2017

LSE: VER

FDA Issues a Complete Response Letter on CCP-07 NDA

Vernalis plc announces today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-07.

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. The CRL did not raise any concerns with the formulation or pharmacokinetic profile of CCP-07 but did identify outstanding items that need to be addressed prior to the resubmission and approval of the NDA.

"We remain committed to the approval of CCP-07 and will work closely with the FDA to resubmit the NDA as quickly as possible" said Ian Garland, CEO of Vernalis plc.

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:

 
 Vernalis plc: 
 Ian Garland, Chief Executive 
  Officer 
  David Mackney, Chief Financial         +44 (0) 118 938 
  Officer                                 0015 
 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 
 

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

UPDUROARBAASUUR

(END) Dow Jones Newswires

April 21, 2017 02:00 ET (06:00 GMT)

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