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Remepy, Merck KGaA collaborate on hybrid drugs combined with AI-personalized digital therapeutics

Remepy, a New York-based digital health startup, has entered a hybrid drugs collaboration with Merck KGaA (FRA: MRK.DE; OTC: MKKGY), Darmstadt, Germany, to develop combination drug-plus-digital therapeutic products across multiple disease areas. The agreement will initially target rare tumor programs in the US, with a stated intent to extend the framework across Merck KGaA's broader portfolio. Financial terms were not disclosed.

The collaboration pairs Remepy's Hybrid Drug platform — described by the company as a novel therapeutic category combining a conventional pharmaceutical agent with an AI-personalized digital protocol delivered via mobile application — with Merck KGaA's existing drug assets. Remepy, founded around 2021–2022 and operating with a dual US–Israel presence, positions the platform as a regulatory and commercial construct distinct from standalone digital therapeutics or conventional drug-companion app pairings.

Deal context

The Hybrid Drug platform integrates two components into a single prescription product: a pharmaceutical agent and a software-based intervention encompassing motor, cognitive, and behavioral protocols. The digital component uses AI to personalize and adapt the protocol to individual patients, though the specific AI methodology is not disclosed in company materials. Remepy describes the combined construct as generating outcomes that neither component achieves independently, citing published literature on multidisciplinary care models and adjunct digital interventions in conditions including ADHD and oncology-related pain.

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The regulatory environment underpinning the deal has shifted in recent years. The US FDA's Prescription Drug Use-Related Software guidance and evolving Software as a Medical Device-Drug combination pathways now provide clearer routes for integrating software directly into a drug's label and reimbursement profile. Remepy frames these developments as enabling the platform to operate within established pharmaceutical development, validation, and reimbursement economics rather than the separate and historically fragmented digital health market.


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