Swiss-headquartered pharmaceutical company Novartis AG says it is looking to get regulatory approval to market medicine, in tablet form, that comes with an embedded microchip. Martyn Warwick wonders if it will also come with an indigestion remedy.
Novartis says that its new "smart pill" will feature one of its established and already-licensed drugs used to prevent organ rejection in transplant patients as well as a tiny microchip, activated by stomach acid, that will send data to an adhesive patch worn on a patient's skin. In turn, the patch will wirelessly transmit health information from the individual either to a smartphone or over a web connection to a physician.
The pharmaceutical company says regulatory approval should be secured within the next year and a half. Trevor Mundel, the global head of development at Novartis says, "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, but I see the promise as going much beyond that."
The announcement come close to a year after Novartis paid US$24 million to get its hands on "chip-in-a-pill" technology that was being developed privately by Proteus Biomedical of California in the US.
Trevor Mundel says that at first the project was all about ensuring that patients took the right drugs, in the right dosage, at the right time. Such a regime is both necessary and highly desirable in transplant cases because drug intake and efficacy can vary greatly as treatment progresses.
Now though, Novartis' ambitions are expanding and the acquisition of the Proteus Biomedical technology has allowed the company to steal a march on its competitors - many other pharma companies are also researching smart pills but it looks as though Novartis could well be first to market.
What's more because the microprocessors (and the emphasis here is very much on the "micro") are embedded in a proven drug that is already licensed, the company expects that it will not have to undergo lengthy and costly new clinical trials before introducing the new smart pills to the health care market.
So rather than full-scale new trials Novartis hopes it will be allowed to re-prove the drug's efficacy, after a microprocessor is added to the ingredient mix, via a mechanism known as "bio-equivalence" whereby the drug in question will be demonstrated to be exactly the same as the original.
And that's only the start. The Proteus chip can collect a wide range of biometric data from heart rate information, through to body temperature, body movement, the monitoring of parts of the human nervous system and so on and Novartis intends to expand its range of smart pills to treat other illnesses and medical conditions.
The only fly in the ointment (if you'll pardon the pun), is that Novartis may have to design safeguards to prevent the information being sent from inside and on a patient ending up somewhere other than it should be destined.
As Trevor Mundel says, "The regulators all like the concept and have been very encouraging. But they do want to understand how we are going to solve the data privacy issues."
And it's an odds on bet that such issues will be sorted out, not least because the smart pills will sell for a lot more than the common or garden variety of dumb drugs and profit is a mighty motivator.
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