Proteus Digital Health and Otsuka Pharmaceutical have expanded their partnership on digital therapeutics.
On Thursday, Proteus announced that it received $88 million from the pharma company, which will go toward the continued development and commercialization of its ingestible sensor pill platform. Additionally, the five-year deal will also support the investigation of a wider digital medicine portfolio, Uneek Mehra, chief financial officer at Proteus Digital Health, told MobiHealthNews.
“The $88 million investment — which includes equity and other payments that Otsuka will be making as part of this collaboration — will really be around developing a portfolio of digital and antipsychotic drugs,” Mehra said. “The first one people are already aware of: Abilify, on the MyCite platform.”
Mehra said that his company and Otsuka will be almost exclusively focusing on digital treatments for mental disorders in the upcoming few years. However, he also noted that Proteus has “five years of evidence” regarding the use of the ingestible sensor platform with cardio, metabolic, and infectious disease treatments, and that such treatments shouldn’t be ruled out in the long term.
“Of course we’ve kept our lines open and are evaluating and exploring other areas outside mental health,” he said. “But we still have enough right now on our plate in terms of our plate in terms of antipsychotics and to deliver that to patients. Our [recently announced] collaboration allows both companies to expand upon our promise.”
What’s the impact
For Proteus and Otsuka, last week’s announcement is a reaffirmation of what both companies describe as very fruitful endeavor.
“It’s been a constructive six-year journey. Not only do we have the device approval, but together with Otsuka we brought the digital Abilify drug approval, where we have sort of established a new battery,” Mehra said. “At this point in time, both companies are very excited for the future.”
On the macro scale, however, this agreement represents another substantial investment by pharma into the up-and-coming field of digital medicines. While it’s certainly good news for Proteus, Mehra felt that it’s also a good omen for any other companies looking to marry therapies with data analysis.
“We are pushing the boundaries of digital health in terms of feedback loop and accurate ingestion data,” he said. “I think the agreement and the deal announcement signifies for the wider community that digital medicine — linking drugs with data across a device platform — has now become a true reality. It is no longer a myth, or a figment of imagination. A sizable company invests a sizable amount of money into this, and I think it opens the door for other companies to think about whether they would want to participate in creating similar value for patients.”
Not to be lost in this is also the increased availability of an alternative mental health therapeutic that this new deal will enable.
“The main value proposition of the treatment is to improved health outcomes to these mental health patients. In other words, this collaboration will try to deliver improved care outcomes to patients, improve their care modalities — and that’s what we’re really excited about,” Mehra said.
What’s the trend
Proteus had its first patch cleared in 2010 and its first pill cleared in 2012. But it made headlines last November when the FDA approved Abilify MyCite, which allowed the digital ingestion tracking system to be combined with a therapeutic. Before, clinicians had to take the pill and add the Proteus chip, whereas this system more closely integrated the sensor and pill.
Since last year’s FDA approval, a handful of systems and health plans have shown interest in the sensor-equipped platform, including Magellan Health, Desert Oasis Healthcare, and most recently Children’s Health.
Shortly following Abilify MyCite’s approval, some prominent voices in digital health noted the potential for privacy breaches or other foul play that are inherent with system that monitors and collects data on users’ behavior.
“I think that this Big Brother concept is a real issue, and people want to function autonomously and they don’t necessarily want anybody looking over their medicine when they take the medicine, if they take the medicine,” Dr. Eric Topol, founder and director of the Scripps Translational Science Institute, told MobiHealthNews. “It is important for treatment of certain conditions — like for example tuberculosis, you can’t get a cure without a very tight adherence. But for many conditions, lack of full adherence might not have a big impact. So privacy and security is a big deal, but there’s this tradeoff here, which is [potentially] counterbalanced by much better results.”
On this topic, Mehra also said that he believed that positive outcomes, healthy behavior changes and other substantial benefits should be the primary focus of those judging the platform.
“We have evidence that if patients take the medicine as prescribed and on time, especially in the chronic disease setting, it leads to a better outcome. It leads to patients being much more in control of their health,” he said. “That constructive engagement has been beneficial — it changes behavior in the patients, even if they adopt this platform for three months, six months. … That’s really what we would like to communicate to people watching from the payer segment, from the provider segment.”
On the record
“We are pleased to continue to focus on opportunities to further integrate digital medicines into healthcare eco-systems to provide value-added outcomes for patients suffering from unmet medical needs in the mental health field,” Kabir Nath, president and CEO of Otsuka America’s Otsuka North America Pharmaceutical Business Division. “Our expanding collaboration with Proteus is a cornerstone of this strategy, and further enables us to serve the mental health community by developing additional innovative technology solutions.”