Allergan and Heptares enter global R&D licensing agreement potentially worth US$3.35bn

Allergan Pharmaceuticals, a division of Dublin-based Allergan, has entered into a licensing agreement with Heptares Therapeutics under which Allergan will gain exclusive global rights to a portfolio of novel subtype-selective muscarinic receptor agonists in development for the treatment of neurological disorders, including Alzheimer’s disease.

Under the terms of the agreement, Heptares will receive an upfront payment of US$125m and potential milestone payments of up to $665m associated with clinical development and the launch of the first three licensed compounds for multiple indications.

The Welwyn Garden City, UK-based firm could also receive up to $2.5bn, dependent on achieving some annual sales thresholds during 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 $50m to a research and development programme to be conducted jointly by the two firms.

Allergan will be responsible for the development of licensed compounds upon initiation of Phase 2b studies and for subsequent manufacturing and commercialisation 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.

The Heptares M1 compounds have shown promising results in early development

'Cognitive impairment and psychosis are progressive and debilitating symptoms associated with many CNS diseases, including Alzheimer’s disease, with few approved therapies available,' said David Nicholson, Executive Vice President and President, Global Brands Research and Development at Allergan.

'The Heptares M1 compounds have shown promising results in early development in their ability to selectively target the M1 receptor without also activating the M2 or M3 receptors, which are associated with undesirable side effects.'

He added: 'We look forward to advancing these compounds into the next stages of development, and potentially adding new approaches to helping physicians treat patients suffering from the effects of Alzheimer’s disease, an area of medicine where Allergan remains committed to continued innovation.'

Malcolm Weir, Chief Executive of Heptares, added: 'We are delighted that the quality of our muscarinic agonist candidates, discovered and developed wholly in-house, and our translational capabilities have been recognised by Allergan.

'We have a highly committed and experienced partner in Allergan and look forward to working together towards the development of multiple new breakthrough medicines over the coming years.'