Otsuka and Proteus sign 5-year, $88M digital pill partnership

Otsuka Pharmaceutical and Proteus Digital Health have re-upped their global smart-tablet partnership for another five years, aiming to develop a new generation of ingestible sensors.

To kick off the expanded collaboration, Otsuka has handed Proteus $88 million in a mix of equity and other payments to help fund a portfolio of new digital medicines focused on mental health, including continuing commercial work for the sensor-laden Abilify MyCite pill approved by the FDA late last year.

Broadening its work with Proteus forms a cornerstone of Otsuka’s strategy to integrate value-added products, such as digital pills that log adherence, into the larger healthcare system, said Kabir Nath, president and CEO of Otsuka’s North American pharmaceuticals business.

“We are confident that being able to track drug ingestion in patients with serious mental illness will provide compelling insights for patients and their healthcare provider teams,” Nath said in a statement last month announcing the company's contract with Magellan Health to bring Abilify to the U.S. market.

A team of Otsuka and Proteus employees will be dedicated to commercial development and market coordination for Abilify MyCite, which was approved for treating schizophrenia and manic and mixed episodes in bipolar I disorder as well as an add-on treatment for depression in adults.

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The unit will coordinate software, manufacturing and supply chain integration along with the joint development of new digital medicines, including atypical antipsychotics for serious mental illnesses.

“This commitment to a broad, inter-operable platform is the core reason for us to expand our collaboration with Otsuka in mental health,” said Andrew Thompson, president and CEO of Proteus Digital Health, a former Fierce 15 winner.

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The Abilify MyCite aripiprazole tablet’s embedded sensor is about size of a 1 mm grain of sand, made up of ingredients found in food. It activates in stomach acid and sends an electronic signal to a wearable sensor patch within 30 minutes to 2 hours, recording adherence before being eliminated from the body.

Otsuka and Proteus’ initial application had been sent back by the FDA in 2016, which asked for more data on performance in specific real-world conditions and human-factors evaluations of the product’s risks, before refiling and winning approval in November 2017.