Sarilumab - AI vs. PFS - Question for Indijo, page-18

When Amgen signed the $20M deal with West for their Smartdose, Unilife was not in the wearable injector(WI) business or had only just started to think of it. The problem with the Smartdose and a lot of other WI’s is that the patient has to assemble them with a cartridge before they inject themselves. The more complex a device is for a patient to use and or the more effort a patient must go to prior to injection has an adverse effect on patient adherence to a drug regime and therefore an adverse effect on health outcomes from everything I have read and or talked about with others.

The Unilife ReadytoGo WI is prefilled and pre-assembled, it is the only WI that is from my understanding, or at least at this stage and with the contracts/customers we have. The reason that UNS are the only WI that does not require assembly of the cartridge is because to do so would require the Pharma to terminally sterilize the WI with the biologic before they release it to the market. Terminal sterilisation can damage the biologic molecules because they are so sensitive and Pharma’s definitely do not want to risk terminal sterilisation from my understanding, Indi could clarify this. UNS WI can be prefilled and pre-assembled without terminal sterilisation, they are the only WI that can do so and they have strong IP around this technology as I had learned over many discussions.

When West make a statement about the Smartdose they always refer to the unique offering because they use Crystal Z plastic for the container. I had been told that Introducing new material into the drug path is a risk that Pharma’s do not typically like. In the UNS WI, the primary drug container is a standard glass cartridge that can be filled in the Pharma's standard fill-finish lines. No new material in the fluid, no regulatory risk from this angle, no new infrastructure required to fill them.

When I went over to the facility we were all trying to work out how the wearables will work with the pharma customer and fill/finish. I was told that the WI’s are sullied in 2 halves (the outer-shells), along with a nesting tub with the primary drug containers (cartridges). The nesting tub with the primary containers (cartridges) go through the standard fill-finish line and the containers are filled. A robot then takes the filled container, clips it into one half of the outer casing and the two halves are then clipped together. No terminal sterilization is required, the WI is packaged ready for shipping from there.

This is just to add to the discussion, nothing more than that. I remember mentioning, after I visited, that we were talking to the “others” who we were comparing to with them using Smartdose - Amgen. Now much time has passed but it would seem that they are certainly at the table, wanting non-exclusive access to the wearables (as well as other devices) and exclusive access to the 1ml wearable, which we also found out that they had entered into a Master Feasibility and Customization Agreement on the 2nd December, before the Exclusive Agreement was entered into on December 31st, so we have been working with them for a fair while now and talking for years!