AbbVie has entered a global strategic agreement to access Unilife’s drug delivery systems across its full portfolio and has also paid a $5m (€4.3m) holding fee for the rights to enter a development and supply deal to use a combination of two systems - Unilife’s Unifill pre-filled syringe and the Lisa auto-injector – in the treatment of auto-immune diseases.
In the past year and a half, Unilife has struck “unprecedented” supply deals for its injectables with the likes of Sanofi and AstraZeneca’s MedImmune, and according to CEO Alan Shortall this latest agreement shows pharma is looking to enhance the value of its biologics offering through delivery device.
“This deal with AbbVie is really the future of biotech,” he told in-Pharmatechnologist.com. “With over 3,000 biologics coming through the global R&D pipeline, the biotech market over the next 10-15 years is going to be very competitive.”
“These are all high-value [drugs], so the real differentiator going forward to bring value to drive payer support, selection preference and patient preference, is really only in the delivery system.”
Shortall added AbbVie was willing to pay a $5m retainer because these delivery platforms are so sought after by pharmaceutical companies looking to protect their biologic revenues, especially in light of growing biosimilar competition.
While firms have used “block and tackle” techniques to address generic competition – pay for delay, and license generics for example – combining a drug with the exclusive use of a drug delivery system “adds real value to actually compete successfully against biosimilars and other biologics,” he said.
Shortall could not say which target therapies and conditions the Unifill Finesse/Lisa system would be used for, and AbbVie when contacted would not divulge any further information.
Humira (Adalimumab) is one AbbVie drug set for biosimilar competition. The product clocked in sales of over $10bn worldwide in 2013, accounting for more than half of the firm’s total revenue. The US patent is set to expire in 2016, and there are a number of firms developing biosimilar of the rheumatoid arthritis drugs, including Zydus which launched the first version last month in India.
Patient Self-Administration
Unilife’s Lisa system uses Bluetooth and Wi-Fi to remind patients via smartphone apps when it is time to take medication, with the ability to send data directly to a cloud, doctor’s office and also the pharmaceutical company, all of which will support patient compliance.
“It is access to the type of data which actually shows adherence which will drive value and drive market share and revenues,” Shortall said.
“Many pharma companies lose actual revenues when patients don’t adhere to drug regime” he continued, adding Unilife’s systems make it easy, safe and convenient for patients to self-administer – generating outcomes which will be supported by payers.
Sanofi and Wearables
In November, Sanofi signed an exclusive 15-year deal to use Unilife’s wearable injectable platforms across its pipeline – excluding insulins – in what some commentators worked out could equate to $1bn of revenue for Unilife annually.
Such a platform can be worn under clothes and automatically delivers large molecule drugs through the subcutaneous fatty tissue in the abdomen over time, and crucially, without the need of a physician.
“Sanofi has done extensive due diligence and our technical abilities provided them the confidence to sign a 15 year exclusive supply agreement to commit to our company for a complete category of our device,” Shortall said.
“Our delivery systems form part of the label thus it’s a critical element for the pharmaceutical company because they can’t simply change to another supplier or another device.”
While there is no wearable injector delivering biologic commercially in the market at the moment, Shortall predicted within ten years the market could be worth $8.5bn annually for the device alone.