Allergan’s wholly owned subsidiary, Allergan Pharmaceuticals International Limited, and Heptares Therapeutics, a wholly owned subsidiary of Sosei Group Corporation, a biopharmaceutical company, have agreed to a pact under which Allergan will license exclusive global rights to a broad portfolio of subtype-selective muscarinic receptor agonists in development for the treatment of major neurological disorders, including Alzheimer’s disease, in a deal valued up to $3.3 billion.

Under the terms of the agreement, Heptares will receive an upfront payment of $125 million and is eligible to receive contingent milestone payments of up to approximately $665 million associated with the successful Phase I, II, and III clinical development and launch of the first three licensed compounds for multiple indications and up to approximately $2.5 billion associated with achieving certain annual sales thresholds during the several years following launch. In addition, Heptares is eligible to receive up to double-digit tiered royalties on net sales of all products resulting from the partnership. Allergan is also committing up to $50 million to a research and development program to be conducted jointly by Allergan and Heptares aimed at advancing multiple candidates through Phase II clinical studies. Allergan will be responsible for the development of licensed compounds upon initiation of Phase IIb studies and for subsequent manufacturing and commercialization of the products.

The agreement covers selective small-molecule agonists targeting muscarinic M1 and M4 receptors in the brain, discovered using Heptares’ proprietary StaR technology platform. Allergan will receive exclusive rights to a broad clinical and preclinical portfolio of M1, M4 and dual M1/M4 agonists, including HTL9936 and HTL18318, selective M1 agonists currently in Phase I clinical development.

M1 selective compounds are in development for the potential treatment of symptomatic cognitive deficits in Alzheimer’s patients, with the potential upside of better tolerability and a more pronounced effect compared with available treatments. M4 selective compounds may provide a novel approach to treat the neurobehavioral symptoms (psychoses) associated with Alzheimer’s disease and related neurological disorders, through a different mechanism of action than available antipsychotics. Combined, dual M1/M4 agonists may be able to treat both cognitive impairment and neurobehavioral symptoms.

This transaction is subject to customary clearances under the Hart-Scott-Rodino Antitrust Improvements Act.

Heptares is a clinical-stage company developing medicines targeting G protein-coupled receptors (GPCRs), a superfamily of 375 receptors linked to a wide range of human diseases. Heptares’ proprietary StaR technology and structure-based drug design (SBDD) capabilities are used to engineer and develop drugs for validated, yet historically undruggable or challenging GPCRs.

Source: Allergan