Orexo exits depression DTx alliance with GAIA

Four years after buying exclusive US rights to GAIA's digital therapeutic to help people with depression, Swedish drugmaker Orexo has terminated the deal.

Deprexis is an online cognitive behavioural therapy (CBT) consisting of 10 modules available in nine languages that is considered to be one of the most widely studied digital therapies in the world and is reimbursable in markets including the UK and Germany.

The decision means Germany's GAIA will regain rights to the DTx, called Deprexis, in the US, and comes as the American market for digital health technologies continues to be hampered by an uncertain reimbursement environment.

"A prerequisite for Orexo to succeed with a sophisticated digital health product like Deprexis is a tight collaboration with healthcare providers and access to viable reimbursement routes, compensating for both the product and the healthcare provider's time," commented Orexo's chief executive, Nikolaj Sorensen.

He added that the company welcomed the recent policy announcement from the Centers for Medicare and Medicaid Services (CMS) enabling reimbursement of digital health programmes.

However, "additional investments are needed in Deprexis to meet the requirements from CMS from both technical and regulatory perspectives" that are hard to justify given the "market opportunity" for the DTx in the US, according to Sorensen.

Orexo's decision comes just a few months after Servier also handed back rights to the programme, bringing an end to a partnership that started in Germany in 2015 and was extended to include additional markets two years later.

The situation in that case is somewhat different, however. Deprexis has been approved in Germany since 2021 and is recommended in treatment guidelines there as an option for people with unipolar depression.

GAIA said the Servier collaboration has had "considerable success," but it made sense for it to regain rights to the DTx that will be sold alongside its other psychiatry-focused products - Priovi for borderline personality disorder and Velibra for panic disorder, generalised anxiety disorder, and social phobia - which are being used by thousands of patients in Germany.

Orexo said in a statement that the decision would have a "positive impact on profitability" in 2025, but would be reflected in an impairment charge in its fourth-quarter results. It added that the value of Deprexis on its balance sheet at the end of November was SEK 71 million (around $6.5 million).

The Swedish company continues to have rights to two other DTx licensed from GAIA, namely Modia for opioid use disorder (OUD) and Vorvida for alcohol use disorder.