Sorry Bio...just stalking you to see what other things you have...

Sorry Bio...just stalking you to see what other things you have had to say recently and found this post that I had missed.

The primary outcomes of the Saril-Ea-Easy  trial has been published. There was nothing in my review of them that got my pulse running. But nothing to make my heart sink either.

http://investor.regeneron.com/releasedetail.cfm?releaseid=914294

The confimation of the primary outcome "There were no product technical failures with the autoinjector" . Its pretty inconclusive for us UNS holders.  

They have released full clinical results for Acertain and Target. But not Easy. To me that means 75% chance Easy is a formality for regulatory filings so makes me suspect that it is more vanillar proven devices vs something new and innovative. But IMO there is some interesting Dick Tracy work around that remaining 25%

If the AID was something different and customised then I suspect the trial objectives would have been more prescriptive and suggestive that there was something to be "tried and validated".

Anyone that has read my ramblings will remember that the Regeneron opportunity was the no.1 reason I held a rather worrying number of UNS shares for a while.  Regeneron has referenced that a bonus for them is the range of devices their partner (Sanofi) can offer them for drug launch, sighting it as an advantage. Sanofi have talked about the importance of device platforms and leveraging them across multi products. A very old presentation discussed the first 3 pipeline drugs REGN-Sanofi drugs as using common device architecture.

So based on Praluent launch in crappy Hypak PFS and vanilla SHL AID its hard to get excited in light of Sarilumab publishings and filings  that UNS are in the mix for Unifil and Rita.

I am at a loss how Praluent was touted to be using state of the art devices that trial patients thought were "kind of hi-tech" and result in the devices we have seen. The worry is it IMO largely locks the device path for Sarilumab and Dupilumab...at least for launch.

I have talked about Sanofi's biggest filling facility for global supply of Lovenox. The same site is their technology and launch hub for injectable drugs so will be doing launch volumes for Praluent, Sarilumab and Dupilumab.


There is still a curious amount of language used by Sanofi and Regeneron about devices. A long time ago Regeneron were doing  trial-test literature and testing of a 2mL syringe with a safety mechanism for needle naive patients. That again sparked my interest.  Sanofi have talked about not wanting to discuss their launch strategies of these drugs. This all sparks my curiosity as to what is there in their strategy other than getting it to market? The formulation wont change due to a launch strategy, the device seems the more obvious factor in any strategy.

Perhaps they are going to market with cheapest, lowest risk, readily available devices and looking at using revenue from launch to help fund the programs to use better devices?!?!? That is largely living in hope, as the smart money is give them 3-5 years before they consider too much in the way of lifecycle management

Getting back to publishing the Ascertain and Target date, I repeat they havent released the full trial data for Easy. In their late 2015 IR call when asked about their Autoinjector they did the same sidestep used for similar questioning re Praluet 12 months earlier. "umm. we believe its too premature to discuss our device and launch strategy" yadda yadda so they are being coy about something.  

I used to have the opportunity to occassionally spring a surprise questions/conversation on Paul Jansen at Sanofi (right place right time at presentations/conventions). Years ago now but there has either been a change in strategy (very plausible) or Sanofi has gone back to its pre Veibacher ways of yes-no-yes-no, shall we confused walks down paths taking their time. If its the latter we could still be in play but wont help us anytime soon re sales.


Another possible curve ball and perhaps an explanation of why a simpler launch device was used vs their long term preferred devices... is

http://www.boehringer-ingelheim.com.../2015/15_January_2015_Biopharmaceuticals.html

Since Sanofi takes the lead with commercial development of the drugs, you have to laugh that they are passing some/much of the actual required drug manufacture to Boehringer as they didnt have the capacity or able to ramp it up quick enough. That could be taken as evidence that they were not as well prepared for this/these drug launches as say their Dengue vaccine and until Regeneron have their Limerick facility up and running and Sanofi expanded their capability...perhaps its a case of keep it simple stupid. Upon testing the waters with drug launches, scaled up production with revenue from sales rolling in to fund new initiatives...like possibly devices

Yadda yadda, yack yack yack. But for me the pre 2018 interest in Sanofi and Regeneron is largely dead. Much like my view that UNS is doing some work with Regeneron with REGN2176-3 and Ocu-Mix (and generally Elyea with Ocu-Ject) the near term opportunity that saw me holding a scary amount of UNS shares around these programs has IMO largely passed and is now a case of sitting and hoping it still happens. Given we are not part of launch strategies...i cant see how I/we can try to bracket timeframes into calendar years for events to look for? It can happen anytime or maybe never at all

LOL, none of this is  helped by Unilifes own lovable tendency to mix and match facts. The kind part of my heart suggests that on again and off again number of lines Unilife has talked about the past 18 months could be confused by the likes of Sanofi saying "get ready, show us the production capacity....sorry we are going with a more conservative approach....oh wait we have this other drug...oh lets be conservative. "

But as of today, Sarilumab filed with regulators, no UNS announcement about Rita or new Unifill progam. Questionable manufacturing capacity. UNS statements about no regulatory filings in our devices...

But always wise to keep an eye on the FDA Advisory Committee calendar

http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

To look for when they are going to publish papers like
http://www.fda.gov/downloads/Adviso...MetabolicDrugsAdvisoryCommittee/UCM449867.pdf

There is always loads of visibility in such documents

I have not looked at Dupilumab or Praluent for a while but after easter could well be worth a thorough review to see what they are doing if anything around Praluent for their 300mg program and the Atopic Dermatitis trials with Dupilumab in 300mg for what may be doing with our wearable

Anyway, thats 60mins of my life spent writing this