February 8, 2017
MAKOR MERGER ARBITRAGE RESEARCH - ATLN VX - DEAL UPDATE - CONTACT WITH PRAC AND ACTELION
ACTELION (ATLN VX)
Deal Update – Contact with PRAC and Actelion
It is worth noting that PRAC meet once a month – this month (February) meetings are scheduled for 6-9 February. In January 17, meetings took place between 9 and 12 January.
As per the website, PRAC publish meeting highlights on the Friday after the Committee Plenary. Therefore, we would expect the meeting highlights for the ongoing meeting to be published on Friday, 10 February.
The draft agenda for the meeting was published yesterday in line with the guidance on their website “agendas are published before start of the Committee plenary.”
We reviewed the 2015 meeting highlights (last full year for which published information is available), and PRAC appears to have discussed and evaluated in excess of 2,000 “signals”. It would appear that following the PRAC’s evaluation that one of the drugs under evaluation was withdrawn approximately a year after the PRAC first evaluated the drug.
Contact with PRAC:
Uptravi is on the agenda as a “signal of fatal cases in patients with PAH”. According to PRAC, “signal issues” are usually raised the month before i.e. it became known to PRAC between the time of the January meeting (9-12 January) and now and hence appears on the February agenda. France’s medical regulator issued a letter to doctors on 24 January not to start treating new patients with the medicine and therefore it is possible that this is on the agenda in response to this (she was unable to definitively confirm when Uptravi was added to the agenda).
They will publish the meeting highlights on Friday and it is very hard for them to say what the outcome of the meeting would be or if there will be any other statement released by PRAC in relation to this, however, the PRAC source said it is unlikely they will specially issue something on this.
Contact with Actelion:
Actelion IR would not make any comment around the PRAC meeting or whether Uptravi was always going to be on the February agenda or if this is in response to the French medical regulator issuing their letter. He would not comment if Actelion would put out any sort of release following the PRAC meeting or when they expect an update from the French medical regulator as to the safety of Uptravi.
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