I try not to use black and white thinking. You say Amgen are strongly tied to West like its a marriage. West supply a HUGE amount of packaging components to just about every pharma. So they are a player. Amgen gave 20million to West to have exclusivity to their Smartdose. Smartdose seems to be the first of the non-insulin based pumps that is going to hit market. So they were the first partnership confirmed and bearing fruit.
So they obviously have common interests for Repatha and other drug-device programs they use. But driving Amgen into UNS arms? Again too black and white.
I personally believe that our wearables have their merit, just like I do Smartdose. Bluntly as a pharma engineer I prefer West. As a patient I would prefer UNS.
IMO Smartdose is superior in ways to benefit pharma by being simpler and cheaper to get to the patient. I have talked about that on occassion but I guess people just take that as bashing rather than criticla thinking.
UNS wearables on the other hand are heavily biased to the patient. So the first layer of thinking I will apply is pharma who want an easier and cheaper drug to fill for a wider range of drugs would firstly look to West. Pharma who are happy to pay for extra filling/assembly lines and complexity in the interests of giving patients the simplest device to use will more likely look to UNS wearables first.
Why? With West a patient inserts a filled cartridge into the device. So think about how the same pharma would use an automated line to insert the filled cartridge into the UNS wearable shells. You are talking tens of millions of clean room/facility space, warehouse space, QC to store the UNS wearable components awaiting assembly around the filled cartridge. Machines and automation for that assembly. So sure the actual cartridge can be filled in a std filling line...but how does the cartridge end up in the wearable? I understand UNS understand this and have tooling/machines to assist pharma, but its a cost, time and facility space.
Not the end of the world...but it is what it is. For West, they make the patient take 60 seconds to install the filled cartridge into the wearable before administration. Surely an open minded person thinking about what I am writing can understand its far simpler and more cost effective to get the patient to do it. The flip side its not as convenient for them.
Also, many drugs are lyophilised. Alan has mentioned that our wearables can reconstitute a twin chamber cartridge in our wearable. THAT IS MEGA for patients. But as per above its a nightmare for pharma who want to use a device that does all that in a pre-filled device.
The flip side, the West wearable can be shipped to pharma fully assembled and ready for the cartridge. For a lyophilised drug the cartridge can be shipped with the drug powder and a vial of diluent. Using a WEST Mix2Vial Reconstitution System or similar the patient can easily mix the diluent with the lyophilised cake and then insert the mixed product cartridge into the Smartdose housing and use away.
So again you can see that maximising patient convenience adds far greater complexity and cost to our devices. When Sanofi signed up it was a great relief as some of their pipeline are reconstituted drugs and means that our wearables had to be able to reconstitute. So was hardly a surprise when Keith and Alan had that conversation many moons ago about delivering miracles
If you are in a clinical trial, you can just fill tray after tray of cartridges and ship them independent of the Smartdose...cheaper and easier for already costly trials. For our device they have to again assemble the device around the cartridge adding time and cost to getting the drug to the trial patients. The automated line isnt a big deal for a new drug line but to do it in a pilot plant for low volume for clinical drugs? Again...more ball ache pharma have to wear so that the patient doesnt have to
This is all the sort of thing I consider as an engineer who designs, builds and commissions facilities. I work with all the folk from every department. I can tell you the facility to fill a UNS wearable would be more expensive then a facility to fill a Smartdose. No crime, there are obviously Medimmune, Sanofi and now Amgen who feel tha premium is well worth it for certain patient groups.
Lastly West is using CZ technology which IMO given more time will be very attractive for many of the more complex biologics over plain old fashioned glass and what comes with it. More than anything for us we can consider the elimination of glass breakages. Has be to a consideration when you have a prefilled device getting bounced during filling, bounced around in delivery trucks, on/off shelves, into the handbag and then onto the person vs plastic that wont break. CZ will also be more compatible with more drug molecules themselves. Not a game breaker but an advantage none the less. The flipside, likely to require longer/more stability trials. Indeed its my belief that the material and stability info for Smartdose is the reason Amgen didnt file its single 420mg Repatha dose in a pump hen it did its original filing. Swings and roundabouts
So I try not to look at being better or worse, but just different. They all offer different value/merit/benefits at various points of the life cycle. So I would expect Smartdose and Precision Therapy to be used side by side for different Amgen drugs as I see certain patient groups, drug markets accepting both.
Indeed it would be mega if Amgen shelved Repatha in Smartdose and went Precision Therapy....as i see our device maturity when Amgen signed with West being an issue for us. Moving forward? I still tend to think the actual differences in devices will make them suitable for different situations
West received 20million for exclusivity in mid 2013 and by mid 2016 it appears Repatha will be approved. So lets see if Amgen can get a UNS drug to market in less than 3 years.
Thats a whole load of hangover posting for a Sat morning...but i think if people delve into such thinking they wil get a far better understanding of the landscape. FFS why are Ultrasafe Needle Guards everywhere and Unifill still sitting in UNS warehouse
