More good news: PCSK9 Update, page-2

Not sure I would use the term we are on a winner Do people think UNS are a factor in the Sanofi-REGN launch of Praluent in a PFS or AID?!?

The case for wearables is still swimming IMO ? LOL, opinions will differ I guess

The trials referenced in the Sanofi-REGN FDA application are all 75mg and 150mg trials.

The latest Praluent info confirms that the Choice I trial and 300mg dose is a good play for our wearables but to date all the trials have been done using 2 x 150mg injections. So still a long way to go.

So hopefully we see a trial in the coming 6-12 months for a single 300mg dose and that they start to include the 300mg dosing in their long term CV trial

The fact that Amgen are using their 420mg dose and Smartdose in ongoing long term trials for CV events puts them well ahead should they get a favourable ruling about CV events.

There is also rather tanigble info that suggests Amgen didnt file Smartdose at the same time as Sureclick last year as they didn't have enough stability data. So combined with being a new device to market they chose a conservative regulatory path.

So assuming an August-ish approval for Amgen and Sureclick, I have read they will have sufficient stability data at the end of the year. So around Dec-Jan they could file a supplement to include Smartdose as a delivery device. I guess that puts them around June '16 for being able to sell their 420mg monthly dose in Smartdose.

It appears Sanofi-REGN will win the race to market by a few valuable weeks, with a stronger rollout in the tail end of this year. But Amgen are well ahead with regards to use of a wearabel in trials and readiness for launch of the more convenient monthly dosing (and quite possibly further progressed with CV trial data)