The approval covers use of the device in the delivery of epinephrine for emergency treatment of allergic reactions and was granted after a 10-month review by the US Food and Drug Administration (FDA).
The award is ‘tentative’ because Intelliject is embroiled in a legal battle with King Pharmaceuticals, recently acquired by Pfizer, which alleges that e-cue infringes on a patent held by its subsidiary Meridian Medical Technologies for its EpiPen product.
However, according to Intelliject spokesman Neil Hughes, the firm is confident the dispute will be favourably resolved on the basis that e-cue, previously known as EpiCard, is different from technologies currently available.
Hughes told in-Pharmatechnologist.com that the credit card sized device is designed to be more portable and user friendly than other autoinjectors on the market.
“It [e-cue] also talks to you,” he continued, explaining that the device issues clear audio instructions to ensure it is used correctly.
Sanofi licensed US and Canadian manufacturing and commercialisation rights to the device in 2009 in a deal that could earn Intelliject $230m (€161m) in milestone payments and royalties.
Delivery platform
However while Sanofi holds the rights to e-cue in the emergency epinephrine market, which is worth some $320m a year in the US alone, Intelliject can still develop the device for the delivery of other drugs according to Hughes.
“Our development pipeline for the device includes applications in diabetes, pain and cardiovascular disease,” he explained adding that plan is to either seek partners for the products or develop them in house.