Novartis closer to filing EU application for ‘smart pill’

Published: 16-Nov-2010
Drug Delivery Research & Development Analysis Pharmaceutical

Novartis hopes to seek regulatory approval within 18 months for a pioneering microchip pill

Novartis plans to seek regulatory approval within 18 months for a pioneering tablet containing a microchip, it announced at the recent 2010 Heath Summit in New York.

Novartis is working with California-based Proteus Biomedical on the so-called ‘smart pill’ concept for a drug used in transplant medicine. The Redwood City company’s ingestible technology paves the way for microsensor-enabled medications that provide patients with valuable information to customise therapy.

Called ingestible event markers (IEMs), the tiny digestible sensors are made from food ingredients and are activated by stomach fluids after swallowing. Once activated, the IEM creates an ultra-low-power, private digital signal detected by a microelectronic recorder configured as either a small bandage style skin-patch or a tiny device inserted under the skin. The detector date- and time-stamps, decodes and records information such as type of drug, dose and place of manufacture, and also measures and reports physiologic parameters such as heart rate, activity and respiratory rate. This data can be combined at server-level with other telemetered parameters such as blood pressure, weight and blood glucose.

IEMs are extremely economical to produce, costing a few cents per sensor in large quantities. The device is at the heart of Proteus’s Raisin System, which is currently in clinical development for individualised care and health management incorporating patient-selectable sharing of information with health providers and caregivers.

Trevor Mundel, global head of development, Novartis, told the Reuters Health Summit in New York: ‘We are taking forward this transplant drug with a chip and we hope within the next 18 months to have something that we will be able to submit to the regulators, at least in Europe’.
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