Five days ago, on August 3, Medgadget ran a post about a tentative FDA approval of e-cue, an innovative portable epinephrine autoinjector from a Richmond, Virginia firm Intelliject. To follow up on this report, we have asked the company’s President and CEO Spencer Williamson to answer our questions…
1) We understand that the idea for this device came from the personal experiences of your founder(s). Could you tell that story?
Our founders, twins Eric and Evan Edwards, were diagnosed, as young children, with life-threatening allergies to a wide range of items, including peanuts, tree nuts, seafood and eggs. Eric and Evan were supposed to have a dose of potentially life-saving epinephrine close at all times. Over time, however, they became increasingly frustrated that the epinephrine delivery systems available were not designed with users like them in mind. In the twins’ opinion, the devices were awkward to carry and difficult to use.
In their late teens, Eric and Evan decided to develop a better solution for millions of people like themselves. They conceived of a new epinephrine delivery system that was truly “developed by patients, for patients®.” They shaped their education to provide the skills needed, and together with their family and some initial financial supporters, they formed a company to make this a reality; and so Intelliject was born.
2) Why did you feel that a new auto-injector was needed? What advantages does this device offer over the current generation of auto-injectors? How is you technology different?
We believe that patient engagement is critical in successful healthcare administration. Our vision is to empower patients to gain freedom from their medical conditions. Our strategy is to provide drug/device combination products that are demonstrably superior for patients, providers, payers.
Intelliject’s approach has two distinct characteristics. First, we configure our proprietary technology using a high and ongoing level of patient input to develop a customized, tailored solution for a particular population. “developed by patients, for patients®.”
Secondly, each Intelliject product combines an established drug, an innovative delivery platform and a supporting data dossier intended to show superiority, patient preference and/or cost effectiveness data.
In head-to-head studies, users were more likely to successfully inject epinephrine using Intelliject’s epinephrine auto-injector than the current standard of care. Users also expressed a high preference for the prototype device product versus currently available options.
3) The device seems quite compact- just how portable is it? Can it be carried in a standard man’s wallet or a pants pocket?
It is the height and width of a credit card and the thickness of a small cell phone and has been designed with portability, ease of use and safety in mind. It is designed to fit easily in a pants pocket or shirt pocket.
4) Your website touts the e-cue as being safer than existing technologies. Tell us about the safety profile.
We are careful not to make any claims about e-cue™ at this stage, including on on our website.
Each Intelliject product combines an established drug with an innovative delivery platform with the goal of achieving superiority, patient preference and cost effectiveness.
The FDA has tentatively approved the e-cue™ for emergency treatment of allergic reactions including anaphylaxis. Tentative approval means that the product review is complete and the submission met the FDA’s requirements to be approved. The FDA reserves final approval of the product, however, until all exclusivity or patent challenges have been resolved, specifically the current patent litigation brought against Intelliject by King Pharmaceuticals, Inc. (King) and Meridian Medical Technologies, Inc. (Meridian). Pfizer Inc., the world’s largest pharmaceutical company, according to published data, owns King and Meridian. Final FDA approval is required before a product can be marketed in the United States.
The e-cue™ has multiple safety features including a retractable needle, safety tab on the same end as the injection needle and verbal instructions to guide the patient through drug administration.
5) Are there plans to use this technology to deliver other medications, such as insulin or dextrose?
We are actively developing other combination products that deploy the Intelliject platform – there are 4 late stage products in our pipeline across multiple therapy areas.
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