AbbVie Says Goodbye to Sosei’s Neurological-Focused Muscarinic Agonist Programs

AbbVie_Smith Collection/Gado/Getty Images

Smith Collection/Gado/Getty Images

Sosei Group Corporation has announced it is regaining the worldwide rights to its muscarinic agonist programs after AbbVie said it is backing away from the program. Allergan, which was recently absorbed by AbbVie, previously penned the licensing pack with Sosei’s muscarinic agonist programs back in 2016.

The partnership with Allergan also came after the company walked away from another $160 million merger, instead agreeing to a $3.3 billion licensing deal for worldwide rights to a neurological disorders drug portfolio from Sosei subsidiary Heptares. Allergen agreed to give Heptares an uprfront payment of $125 as well as $665 million in milestone payments and up to $2.5 billion in milestones related to sales of the developed products.

Muscarinic agonists have been developed to treat various cognitive challenges associated with dementia and neurobehavioral issues. In 2018, Allergan and Sosei voluntarily halted a clinical trial of one of its selective small molecule muscarinic M1 receptor agonist, HTL0018318, which was being developed for Alzheimer’s disease (AD) and other dementias. The trial was suspended because of safety concerns observed in a non-human primates. At the time, the drug had been investigated in a total of 310 human participants across the U.S. and Europe, including health people and patients with mild-to-moderate AD. In 2019, Sosei made the decision to stop development of the compound.

"We are delighted to regain rights to this portfolio of novel subtype-selective muscarinic receptor agonists (M4, M1 and dual M1/M4 agonists), including several clinical and preclinical candidates with substantial data associated,” said Shinichi Tamura, Chairman, President and CEO of Sosei Heptares. “We enjoyed a productive relationship with Allergan over the course of our muscarinic agonist collaboration and continue to work positively with AbbVie on a new program in inflammatory diseases that we announced in June last year.”

Tamura added that the “considerable progress” made between the Sosei/Allergan partnership has reinforced Sosei’s “view in the potential of this approach to create important new products that treat severe and debilitating symptoms of Alzheimer's disease, schizophrenia and other neurological diseases.”

"In addition, the R&D collaboration has generated a diverse pipeline of next-generation, selective muscarinic agonists with novel chemistry that have benefitted from insights gained in clinical trials and from advanced drug design technologies,” Tamura said. “These new and differentiated candidates exhibit highly attractive properties for further development.”

Tamura noted that Sosei is currently developing and looking for a new partner for the program. The news coincides with the company’s announcement of its full-year results, which is planned for some time in February 2021. According to Sosei, the retainment of the worldwide rights to its muscarinic agonist programs will have “no immediate impact on the consolidated financial results of the accounting period ending December 2021.”

Back in June, Sosei Haptares and AbbVie announced a discovery collaboration and licensing partnership, which is seeking to develop and commercialize novel treatments modulating G protein-coupled receptor targets for inflammatory and autoimmune diseases. AbbVie agreed to pay Sosei an upfront and near-term milestone payments of $32 million. Possible milestones of up to $377 million and tiered royalties on global commercial sales were also inked into the deal. The partnership allows AbbVie to expand the collaboration to up to four targets.

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