New wearable large volume delivery device can extend patent life – begin 5 years ahead

Nearly 60 percent of pharmaceutical combination product experts say the device constituent is being introduced into the drug or biologic program too late, causing issues and compromises, according to a recent EdgeOne Medical survey.

Many of these issues could be mitigated by incorporating a newly available, disruptive, wearable large volume delivery device (LVIs) early on, helping not only to de-risk biologic drug development but also to bring many marketable benefits to the administration of biologics.

The most advanced LVIs enable patient self-injection that is safe, easy, comfortable and convenient – yet cost effective for the pharmaceutical industry, payers and the healthcare system.

New wearable large volume delivery technology, first developed at Cincinnati Children’s Hospital to provide pain- and stress-free injections to improve compliance, is expected to do just that–for any age.

Additional benefits and features for patients and pharmaceutical companies including these:

• Subcutaneous self-injection of even the largest doses–10 mL to 50 mL – replace IVs and significantly lower healthcare system costs
• Product differentiation in a competitive market
• Pressure-sensing technology adjusts flow rate, reducing or eliminating injection pain, stress
• Simpler, faster product preparation for development teams
• Faster time to market
• Fills using standard vials or syringes, eliminating need for new container closure stability studies
• Automatically warms the drug as device fills – in seconds –removing the typical 30 minute waiting time for refrigerated vials to reach room temperature
• Automates mixing and reconstitution of lyophilized drugs, removing any patient variability from the mixing process
• Uses smallest possible needle size possible while still delivering even the most viscous biologics with little or no discomfort
• Low profile wearable about the size of an Oreo cookie – treatment can be administered at home, at work or on the go with complete freedom and mobility
• Data capture to aid in monitoring patient adherence to prescribed therapy
• Green technology – no batteries

Patent extension that can also win patient loyalty

For the 11 established biologic products – representing 48% of total biologic sales – that are slated to lose patent protection by 2022,  now is the time to consider patent extension with a combination biologic/device product that takes advantage of the many benefits of the new wearable LVI technology.

At the same time, these combination products, specifically designed to vastly improve the patient experience, can quickly create patient preference and buzz.

First movers have the opportunity to also differentiate their young commercial products, as well as those whose patent expires in the next five years or beyond.

Biologics no longer as hard to make, hard for patients to take

Never has there been a greater need for innovation to enhance the patient experience and compliance than with the large volume, viscous biologics that now comprise more than 50% of products in pharmaceutical development.

For biologics, issues of viscosity, solubility and protein aggregation are major obstacles, especially with the small-gauge needles patients prefer. Now those issues have been resolved, to the delight of patient panels who have tried the new LVIs.

Well balanced pharmaceutical portfolios now include combination devices

In its 2016 Pharmaceutical Industry Report, Deloitte exhorts pharmaceutical companies to embrace innovation.

The consulting firm postulates that as integration of pharmaceuticals and technology gains traction and accelerates, drugs will remain important but will represent a diminishing share of what comes together to deliver an overall outcome.

Disruptive innovation that can positively impact outcomes, create patient preference and lower drug development/health system costs has arrived – the wearable large volume subcutaneous injection technology. Pharmaceutical companies that embrace the technology –and their patients—have everything to gain.