Proteus Digital Health Inc. won FDA approval July 30 for technology that helps patients stay on track with their medicines by building sensors into the pills they swallow, but the medical device is bound for pharma as part of an integrated solution to one of health care’s knottiest problems: compliance.

The ingestible sensor will help the pharma industry bridge the “efficacy-effectiveness gap,” George Savage, Proteus co-founder and chief medical officer, said in an interview. Many wonderful drugs have been proven efficacious, but they are not effective because patients, who by and large want to be compliant, get busy or aren’t sure of what they’re doing after they leave the doctor’s office, he said. With the feedback system, caregivers, health professionals and the patient have data they can use to make intelligent medical decisions and educational suggestions, he said.

This technology is for patients who want to take their medicine and get better but just need help and for physicians who are trying to figure out these patients and whether they might need a different dose or a different drug, Savage explained. It is not for patients who have no interest in complying.

Many wonderful drugs have been proven efficacious, but they are not effective because patients aren’t taking them correctly, Proteus CMO Savage said.

The Approval Path For Digitized Pills

Proteus has been working with FDA since 2008 to find a pathway for approval of the feedback system, Savage explained. “The regulators worked interactively with us,” and the company is grateful for the collaborative way in which they approached the project, he said. The technology, a transmitter roughly the size of a grain of sand, was approved under the de novo process for low-risk devices that have no predicate on the market ([A#01120806010]).

The ingestible sensor was tested in a placebo pill, and labeling allows for consumption of 30 a day, Savage said. “They’re very safe.” The approval is for signaling an event by ingestion. FDA is agnostic in labeling as to what the event might be, he explained.

On the drug side, the company “had many great meetings with [the Center for Drug Evaluation and Research] last year, and now this year it’s about specifics,” he said. Proteus will be going to FDA with partners for individual drug filings.

Still, the company already has worked out an agreement with regulators in the U.S. and in Europe, where the device won CE Mark approval in August 2010, under which ”they’ve agreed to accelerated approval of drugs containing our technology,” Savage said. Though drug makers will have to go through the kinds of quality control testing they would have to do anytime they’ve changed a tablet, “we don’t need to reprove the safety and effectiveness … of a drug that we’re not changing by adding this technology to create a combination product,” he said.

“We’re working with regulators to agree on exactly what they need in their package to approve specific drugs with this digital technology embedded inside,” Savage said.

Proteus intends to go through the process first with partners and then on its own, as it develops products that incorporate the ingestible sensor into generic medicines to be made by a contracted manufacturer. “We’re not a drug manufacturer at this point, though it’s possible that may change over time,” Savage said.

Ingestible Sensors: There’s An App For That

The feedback system comprises the ingestible sensor, a skin patch with a receiver/transmitter in it and a digital receiver, likely a cell phone.

The ingestible sensors are roughly the size of a grain of sand, with a magnesium layer on one side and a copper layer on the other. Both are conductive materials found commonly in food, and in this situation, they become the power source for the sensor’s signal. The conductors remain separate and inert until the medicine enters the stomach and starts to break down. When the sensor contacts stomach fluids and the two materials interact, the reaction creates a brief power source for sending a unique signal marking the exact time the medication was taken as well as its identity.

Proteus' feedback system consists of the embedded ingestible sensor, a Bluetooth-enabled skin patch and a secure mobile app to receive the signal.

Proteus Digital Health Inc.

The signal is received by a skin patch that also collects such context information as heart rate, body position and activity at the time and broadcasts the encrypted data to a computerized device, say a mobile phone with the appropriate application. “There will be an app that will relay the information on to the Internet and different kinds of apps can look at the core medical device, the CMD app, on the phone,” Savage explained. “Different use cases have different visualizations for the patient, depending on the specific therapeutic aim.”

The signal is managed by the patient, who designates the recipient. The disposable adhesive patch contains a battery and a Bluetooth radio. “You wear it for a week and throw it away, then apply a new one to a different area of skin,” Savage said. FDA approved the monitor in April 2010.

Preparing For A Launch In The U.K.

Privately held Proteus Digital Health, in Redwood City, Calif., recently changed its name from Proteus Digital Health Inc. to quash misconceptions that it was a biotech, Savage said, quipping that “Digital Health at least has the advantage of making people say ‘what do you mean by that?’” instead of “What is your lead candidate?” Proteus has publicly disclosed three commercial partnering deals for its technology.

The first, a 2010 deal with Novartis AG, gave the big pharma rights to develop and market organ transplant drugs that incorporate Proteus’ sensor-based technologies in exchange for an upfront cash payment and an equity investment that together totaled $24 million, plus royalties [See Deal].

In addition, the deal gave Novartis option rights in cardiovascular and oncology applications as well as the right to use the technologies in drug development. Prior to the deal, Novartis and Proteus conducted a study monitoring 20 patients taking the blood pressure medicine Diovan (valsartan) and found compliance increased from 30% to 80% ([A#00720030008]).

More recently, Proteus inked a deal with Japanese drug maker Otsuka Pharmaceutical Co. Ltd. July 5 to develop and commercialize pharmaceutical products in two undisclosed areas of unmet medical need. Otsuka also has a non-exclusive license to use the technology in clinical research and development. Financial terms were not disclosed, but Otsuka is listed among the firm’s investors.

The third partnership, with U.K. community pharmacy chain Lloydspharmacy Ltd., will be Proteus’ first commercial venture. “We’ve been at this for about a decade now, and it’s great to be at this point where we’re hitting the market in commercial form,” said Savage. The launch is set for the fall.

The project involves adding Proteus’ ingestible sensors to adherence packaging currently already sold by Lloydspharmacy for patients taking several medications at a time, several times a day in prepackaged blister packs. An ingestible sensor will be added to each of the wells to signal that the patient has taken his or her pills, Savage said. The system is being targeted as an aid to family members who don’t live with a loved one who must take several medications several times a day.

With the U.S. approval, Proteus has begun talks with a U.S. equivalent of Lloydspharmacy to do the same thing, Savage said.

An Experiment In Wirelessly Observed Therapy

In April of this year, Proteus received a grant from the Bill & Melinda Gates Foundation to research, design, implement and validate an enhanced TB treatment monitoring strategy called Wirelessly Observed Therapy for use in high TB burden countries, starting with China.

The study will launch at the end of the year, Savage said. Directly Observed Therapy is the standard today, but it’s difficult to implement because it is labor intensive and invasive for patients. The pilot will determine whether WOT can allow patients to go back to work and not have to be seen in the clinic, yet provide better treatment and better allocation of resources.

“To be viable it has to be incredibly inexpensive, and it will be,” Savage said. The ingestible sensor is a particle size silicone chip that can be produced with the same volume economics of semiconductors, he explained. “The more units I can make, the lower the price gets, just like computer chips.”

“The technology should be very inexpensive and very affordable and help leverage scarce professional resources by leveraging the mobile phone everybody has in their pocket and the Internet to reach more people in the world who have very limited access to health care,” Savage said.

Proteus Digital Health’s Ingestible Sensor Reports When Granny Takes Her Meds

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