In-body microchips that deliver medicine in doses either pre-determined or controlled by doctors from outside the body could be the next big thing in drug delivery, and Teva Pharmaceuticals has jumped onto the bandwagon.
The company announced last week a new partnership with US firm Microchips Biotech to deliver Teva-made drugs to patients using the American company’s implanted microchip. It’s the first deal for Microchips Biotech – and the first ever that seeks to commercialize what some consider to be a controversial technology.
To some, an in-body chip that delivers drugs automatically and eliminates the need to measure out meds – or to even to remember to take them – sounds like the height of convenience and safety, perfect for the elderly and others who often miss doses.
Others – including libertarians concerned over a further erosion of privacy by digital devices and technologies, as well as Christians who are opposed in principle to implanted microchips, are likely to be aghast over what the two companies are doing.
Nevertheless, both fans and foes of in-body drug delivery are going to have to get used to the likelihood that at some point in the future, a doctor will suggest that they, too, be implanted with a chip that doses out drugs in pre-determined increments.
According to Michael Hayden, Teva’s president of Global R&D and Chief Scientific Officer, “the microchip-based implant is truly at the intersection of digital technology and medicine and the future of drug delivery for patients who cannot tolerate needles, require regular self-administered injections or where compliance is critical to outcomes.”
Microchips Biotech, the US firm that developed the technology, manufactures a device made up of microchip arrays that can store hundreds of therapeutic doses of drugs. The self-contained hermetically-sealed drug delivery device is easy to implant and remove in a physician’s office, and it can store hundreds of therapeutic doses over months or even years, the company says.
Each array contains a few milligrams of a specific drug, with the correct dosage released automatically based on a pre-programmed schedule or released in real-time, via a wireless app controlled by the patient or the caregiver.
That last point is a matter of major concern to many in the Internet freedom and privacy activist community. Who’s to say, they ask, that hackers won’t be able to tap in the wifi or Bluetooth communication system now inside the body to reprogram the dosage – perhaps as part of a high-tech ransom or extortion scheme?
That’s a pretty unlikely scenario, according to Dr. Robert Farra, the MIT professor who helped develop the medical microchip and is Chief Operating Officer for Microchips Biotech.
“Someone across the room cannot reprogram your implant,” Farra said in a recent interview. “Communication with the implant has to occur at skin contact-level distance. Then we have secure encryption. That prevents someone from trying to interpret or intervene between the communications.”
That argument won’t sway conspiracy theorists who see microchips as a new way for government to control the population – nor will it satisfy Christians who see the chips as an eschatological indication of the “end times,” when a terrible force will be unleashed in the world to enslave humanity in a “tribulation” that must precede the Second Coming of Jesus.
Part of that tribulation entails taking “the Mark of the Beast,” without which participating in society will be impossible. Many fundamentalist Christians believe that this “mark” may take the form of an implanted microchip, which will be used to keep the population under control.
Regardless, Microchips Biotech expects the system is likely to be widely adapted. The implant has been clinically validated in human studies delivering parathyroid hormone in osteoporosis patients, and the system is fully programmable via wireless communications to adjust dosing by physician and/or patient, the company said.
The microchip-based technology was originally developed at MIT by top researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D.
Under the terms of the agreement, Teva will pay the US firm $35 million in the form of an equity investment and technology access fee, in return for which Teva will be able to license the system to deliver drugs to treat a specific disease area. If that pilot works out, Teva will have the option to later expand the program into several additional therapeutic areas and sensing applications, proprietary to Teva.
As programs advance, Microchips Biotech will receive development and commercial milestone payments and royalties on future product sales. Microchips Biotech will also receive funding to develop products for any future additional indications Teva may develop, and Teva will be responsible for Phase II and Phase III clinical development and regulatory filings.
“We are thrilled to be aligned with an organization that sees the potential of our technology to transform the way medications are delivered to patients, providing the potential to increase compliance and significantly improve outcomes,” said Cheryl R. Blanchard, Chief Executive Officer of Microchips Biotech. “This is the first of what we hope to be many partnerships with industry to leverage our technology across a broad array of therapeutic applications and disease states.”