pipeline

Ok, so sitting around airports doing some reading I think there is enough info in the public domain to have a punt on who UNS may be chatting with regarding some future deals.

I am going to have a punt and say Regeneron are one of the companies.

UNS have announced that they are in discussion with a company for its Ocu-Ject. Well a product called Eylea was approved in US and some regions in late 2011, but in the EU in Nov 2012.

It is on the shelves selling a storm. The catch is that you buy the thing in a vial and comes with a prefilled syringe. You put a thick gauge needle and draw the dose from the vial. You then need to change the needle over to a thinner gauge needle for the injection into the eye. So one shot is a vial, a barrel and two needle tips. The clutter and cost of that means the economics of a UNS syringe could be competitive.

So along with the risk to sterility of changing tips with a charged barrel, is the fact that there is wastage as you draw more than you need into the barrel. Change tips, then get the air out and get the measure right. So that’s waste of vaccine.

So you have clutter, waste of vaccine and risk of sterility for something that is going into your god damn eye! On top of that you also have to be damn sure the physician has got the final dosage right as there are enough complications without over or under delivery of the drug.

So there are 4 pretty sound reasons why they would migrate the vials into prefilled. Ophthotech are hot on their heels with developing their own drug to compete.

SO add to that the fact that Regeneron have been talking to the FDA about using a prefilled version of Eylea. They had some data from the drug development with prefilled syringes but they didn’t have any stability data so went with vials.

So that in itself is good reason for Regeneron to be a customer. But the above means it could equally be Roche and Lucentis trying to get back their market share that Regeneron are stealing.

But the other reason why I think the customer is Regeneron is that they are kicking major Phase 3 trials with one of their drugs that they are in partnership with Sanofi for. Their cholesterol drug Alirocumab is expected to be launched in 2015 which is in line with a UNS statement that a deal for the Lisa auto injector is for a late development drug that is to be launched in 2015.

That same Lisa customer "D" is listed as a Unifill customer as well with the same time lines. The reports of the Phase 3 trial of Alirocumab refer to its use with an Auto injector to simplify self-administration.

The new class of PCSK9 inhibitor based drugs are also being developed by Amgen, Pfizer and Roche so will be a very competitive area.

The real positive is if I am not talking out my bottom then one drug is a proven blockbuster that will be migrated to Unifill for safety and economics. The other is a promising drug that will be entering a competitive space.

And the one customer could result in 3 "deals" with UNS in the next 3 or so months. Unifill and Lisa for the cholesterol drug Alirocumab and Ocu-Ject for Eylea.

Seems quite a reasonable chance by my measure...and I am a miserable git