Alan Shortall, founder and CEO of Unilife Corp., senses a shift in healthcare. “About 50% of all healthcare will be administered outside of healthcare facilities and outside the home within ten years,” he says, quoting an E&Y report. “Healthcare will increasingly be self-injected by patients while they are on the go, such as at work or even the gym.”
To support drug delivery in this patient-centric environment, Shortall says that “physicians will be writing prescriptions for the most portable, simplest and most convenient drug products. As with insulin today, market-leading devices will become the key point of differentiation for injectable therapies across a range of disease states. This emerging need to develop the right device to deliver the right drug to the right patient is shifting our industry away from commodity devices to customized platforms that can address specific needs. Those drugs that are supplied in market-leading devices will typically be preferred for use by patients. Pharmaceutical companies can leverage that patient-preference to build or protect market share from the competition.”
Helping to improve clinical adherence to a patient’s therapy regimen by improving the safety and simplicity of drug delivery can not only improve quality of life, but significantly reduce healthcare costs, he adds.
Unilife develops a range of injectable drug-delivery systems including prefilled syringes with integrated needlestick safety features, auto-injectors, and wearable pumps for long duration subcutaneous injections. “We don’t produce commodity devices for high-volume, me-too products. These are now becoming largely redundant as healthcare shifts to the third-place. We offer companies the opportunity to leverage the differentiation of our devices to build or protect market share in competitive therapeutic markets.”
Shortall said Unilife’s focus on customizable, differentiated devices is resonating strongly with pharmaceutical and biotech companies seeking to enable and enhance the approval and commercial success of their injectable drugs.
The standard drug-delivery approach for injectable drugs has often been the prefilled syringe or handheld self-injection devices such as auto-injectors, Unilife reported to PMP News. However, the complexity of biotech drugs that would be too viscous for injection in a prefilled syringe is now driving development of wearable, disposable devices known as bolus injectors.
These compact, ergonomically designed and easy to use devices are customized to deliver a dose of 1 mL or larger in volume to the patient over a designated duration period such as minutes or hours, Unilife reported to PMP News.
Outside of the use of these devices for many late-stage pipeline drugs, many opportunities also exist to enhance the convenience of many approved therapies such as some that currently require IV infusion in healthcare facilities, Unilife reported.
Shortall suggests bolus therapy as an alternative. “Biologics could be diluted for self-injection into subcutaneous tissue, not veins, and delivered via a bolus injection pump to dramatically improve the quality of life for patients and significantly reduce healthcare costs.”
Shortall believes that about 25% of all emerging biotech drugs could utilize bolus injection or infusion therapy. “In many ways, this is a new class of products, but in a few years, it will be predominant for the treatment of many acute and chronic diseases,” he says.
Patients can wear the pump while working, exercising, or participating in other activities. When dosing is complete, they simply peel off the device for convenient disposal. The device can be customized in terms of shape, dose, duration, or other features.
Unilife has also developed other drug delivery devices targeting specific organs, which in some cases could serve as alternatives to surgery. One project entails delivering microliter doses to the eye. “The eye is an enclosed organ system, and eye pressure is critical,” he says. “You need accurate, precise delivery systems to optimize the clinical efficacy of some of these specialized injectable therapies. Whereas current device technologies may only achieve a delivery accuracy for microliter doses of +/- 30%, our Ocu-Ject device can bring this down to +/- 2%.”