Edison Investment Research - Vernalis PLC (VER) FDA issues CCP-07 complete response letter

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Edison Investment Research

Lala Gregorek

FDA issues CCP-07 complete response letter

FDA has issued a complete response letter (CRL) to Vernalis’ CCP-07 NDA following its 20 April PDUFA date, outlining questions that need to be addressed in an NDA resubmission for potential FDA approval. Given limited disclosure regarding possible timelines for dealing with these questions and the probable class of resubmission, we conservatively push back our CCP-07 approval assumption by one year, delaying launch into the 2018/19 cough cold season. However, we acknowledge that there are scenarios under which CCP-07 could still be launched into the 2017/18 season, albeit later than previously anticipated. Separately, Vernalis has received a $2m milestone relating to an existing research collaboration.

24/04/2017 3 EN

Underlying

Vernalis PLC

Vernalis is a holding company. Through its subsidiaries, Co. is a commercial stage pharmaceutical company focused on drug development. Co. has three marketed products: Tuzistra® XR, in the U.S. prescription cough cold market; Moxatag®, the only once-daily amoxicillin approved in the U.S. for tonsillitis and pharyngitis; and frovatriptan, an acute treatment for migraine. In addition, Co.'s nine programs in its new chemical entity development pipeline are: V158866 for central nervous system indications; CP1-444 and V2006 for immuno-oncology indications; AUY922, Tosedostat, Bcl-2, Mcl-1, and V158411 for cancer indications; and RPL554 for chronic obstructive pulmonary disease indications.

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GB00B3Y5L754 United Kingdom

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Lala Gregorek

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FDA issues CCP-07 complete response letter

CMD showcases expertise and strategy

Vernalis - Operational initiatives in place, execution is key

Tuzistra XR steady growth in Rx run rate

Basilea Pharmaceutica - Cresemba milestone payments continue to roll in

AAC Clyde Space - Solid start to the year with further order growth

Tinexta - Typical seasonality in Q124

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