Allergan today disclosed deals that will expand its gastrointestinal (GI) pipeline with four potential treatments focused on the microbiome, as well as broaden its R&D portfolio through an option to buy a drug developer focused on treating Parkinson’s disease.
Allergan will pay Assembly Biosciences $50 million upfront, the companies said, for exclusive, worldwide rights to develop and commercialize Assembly’s preclinical compounds ABI-M201 and ABI-M301, targeting ulcerative colitis (UC) and Crohn's disease (CD), as well as two additional compounds to be identified by Assembly for irritable bowel syndromes (IBS), with diarrhea (IBS-D), with constipation (IBS-C), or mixed (IBS-M).
Through the companies’ research, development, collaboration, and license agreement, Allergan agreed to make payments to Assembly that will be tied to achieving development and commercial milestones, as well as tiered royalties based on net sales.
Allergan and Assembly said they will generally share development costs through proof-of-concept (POC) studies, with Allergan agreeing to assume all post-POC development costs.
Assembly’s microbiome program consists of a fully integrated platform that includes a strain identification and selection process, methods for strain isolation and growth under current GMP, and the patent-pending Gemicel® drug delivery system, designed to allow for targeted oral delivery of live biologic and conventional therapies to the lower GI tract.
“Assembly is well positioned to identify and select unique therapeutic candidates and deliver them to the optimal site in the GI tract through a novel oral delivery system,” C. David Nicholson, Ph.D., Allergan’s chief R&D officer, said in a statement.
Allergan’s collaboration deal with Assembly is expected to close in the first quarter, subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976.
Separately, Allergan announced its purchase of an exclusive option to acquire Lysosomal Therapeutics (LTI) for an undisclosed sum.
LTI focuses on developing new small-molecule treatment options for severe neurological diseases. The company’s lead program LTI-291 is designed to treat Parkinson’s disease by stimulating the activity of glucocerebrosidase (GCase) in the brain. Approximately 5% to 10% of patients with Parkinson's have mutations in the GBA1 gene that have been linked to decreased activity of GCase.
“LTI is paving a new path in the characterization of Parkinson's disease, including the understanding of a patient's glycosphingolipid profile and its relevance to therapeutic response,” Lysosomal Therapeutics CEO Kees Been stated. “We are pleased to work with Allergan to support the acceleration of LTI's leading GCase activators to reach as many Parkinson's patients as soon as possible.”
Allergan said it has acquired an option to acquire LTI following completion of a Phase Ib trial for LTI-291 and has agreed to offer a separate up-front R&D payment whose amount was not disclosed. Allergan and LTI also said they will establish a joint development committee to oversee the development activities for LTI-291.
Allergan said its R&D expansion into Parkinson’s complements the company’s existing focus on diseases of the central nervous system (CNS).
In addition to the CNS and GI diseases, Allergan’s areas of R&D focus include eye care, medical aesthetics and dermatology, women's health, urology, and anti-infective treatments.