Report

Advancing towards a commercial portfolio

FDA acceptance of the CCP-08 NDA (setting a 4 August 2017 PDUFA date) advances Vernalis towards its goal of building a speciality US franchise of extended release (ER) prescription-only (Rx) cough cold products. Potential 2017 approval of CCP-08 and CCP-07 (PDUFA date 20 April 2017) would enable launch into the 2017/18 cough cold season. Last reported cash of £78.6m (unaudited at end October) supports ongoing investment in operational initiatives to enhance Tuzistra XR sales growth this season and beyond. Successful execution will lay important foundations for the launches of CCP-07 and CCP-08.
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.

Provider
Edison Investment Research
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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