![]() ![]() Abilify is an anti-psychotic used to treat adults with schizophrenia, manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults. The service captures and integrates adherence data from the Proteus Digital Health feedback system directly into an electronic data capture system.Īnd in mid-September Otsuka Pharmaceutical and Proteus announced that FDA accepted for review its NDA for the combination product of Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. These regulatory approvals are just the latest events demonstrating the industry’s growing interest in medication adherence measurement in clinical trials, as well as healthcare in general.Įarlier this year, Oracle announced that its InForm EDC solution was integrated with the Proteus Digital Health Feedback System to form the InForm Medication Adherence Insights Cloud Service. The FDA granted Proteus a label expansion to allow the product to be used to measure medication adherence in early July. But this application furthers the products use in clinical trials in Europe. The Proteus ingestible event marker is approved in the EU and the United States for use as a medical device. Specifically, Proteus requested the EMA to consider the use of its technology “as a ‘qualified method’ for measuring adherence and associating relevant physiologic and behavioral parameters, such as indications of therapeutic response.” Public consultation began September 15, and ends on October 26. The pharmaceutical giant plans to fold Proteus' technology into its digital medicine program, according to executives in a statement when the acquisition was announced.In early August, the EMA issued a draft qualification opinion on “Ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials.” ![]() Otsuka acquired the company through a “stalking horse” bid through its bankruptcy proceedings.Īs part of the asset purchase agreement, Otsuka will buy Proteus' information technology assets, intellectual property, and equipment, including equipment used to design and manufacture wearable sensors. The company ultimately filed for Chapter 11 bankruptcy in June. Proteus attempted to raise capital and get more financing this year but potential buyers were turned off because Proteus was burning through too much cash-to the tune of $2 million a month-and it wasn't clear when the company would be profitable, according to an investment bank the company hired. The startup, which spent almost two decades working on ingestible sensors, made headlines in 2017 when it gained regulatory approval for the first “smart pill” in the U.S.īut the company struggled to find a market for its product, reportedly failed to close a $100 million funding round in 2019, and then lost a development deal with Otsuka Pharmaceuticals. Proteus developed ingestible sensors and a wearable sensor patch to track medication-taking behavior. The high-flying digital therapeutics startup founded in 2001 had secured big pharmaceutical partnerships and raised close to $500 million. While the price would seem impressive for a digital health deal, it’s but a small fraction of the dethroned unicorn’s previous valuation of $1.5 billion. acquired the technology assets of Proteus Digital Health in August for $15 million through bankruptcy proceedings. Why it matters: The American unit of Otsuka Pharmaceutical Co. ![]()
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