Intervacc
Intervacc - Slightly delayed EMA application (ABG Sundal Collier)
2019-11-13 11:03
Strangvac EMA application delayed by a few months
Intervacc still guides for potential approval in late 2020
We still assume a European launch in 2021
Advisor feedback implemented to ensure robust applicationIntervacc has issued a press release updating the timetable for submission of its application to the European Medicines Agency (EMA) for Strangvac. The company now expects the application to be submitted at the end of February 2020, a slight delay from the previously-communicated “end of 2019”. The delay is a result of additional feedback from the company’s expert advisor, and advisory meetings with the EMA being incorporated to the dossier. According to Intervacc, the additional application improvements will pave the way for a rapid and straightforward approval process.
Superior safety profile could expedite a rapid process
Management maintains its guidance that a potential approval in late 2020 is achievable, but the timetable will be highly dependent on the amount and frequency of the questions from the EMA. The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This time is interrupted by one or two ‘clock-stops,’ during which the applicant answers any questions raised by the EMA. The duration of a clock-stop depends on how long the applicant thinks it will take to respond. The first clock-stop usually lasts 3-6 months and the second one 1-3 months. Overall, the process usually takes around one year. Since the EMA questions usually focus on drug safety, we believe Intervacc is well-positioned for a rapid regulatory process.
We assume a European launch in 2021 - with more to come
We leave our estimates for market approval and subsequent launch unchanged. We assume that the launch of Strangvac will occur in 2021e in Europe, as distributors will likely be signed on at around the time of the regulatory submission. We estimate that sales in Oceania will begin in 2022e, because that region is likely a lower priority. W
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