Allergan Signs Deals for GI and Neurological Diseases
Allergan has entered two deals, one for gastrointestinal (GI) drug development and another for development of drugs to treat neurological diseases. The company formed the GI collaboration with Assembly Biosciences, a clinical-stage public biotechnology company headquartered in Carmel, Indiana, and the neurological disease drug collaboration with Lysosomal Therapeutics (LTI), a Cambridge, Massachusetts company focused on small-molecule research for neurodegeneration therapies.
Under the GI collaboration, Allergan gets worldwide rights to Assembly’s microbiome GI development programs, including worldwide rights to preclinical compounds ABI-M201 and ABI-M301, targeting ulcerative colitis (UC) and Crohn’s disease (CD), respectively, as well as two additional compounds to be identified by Assembly for irritable bowel syndromes (IBS) with diarrhea, with constipation, or with mixed diarrhea and constipation.
Allergan will make an upfront payment to Assembly of $50 million for the exclusive, worldwide rights to develop and commercialize the UC, CD, and IBS compounds. Additionally, Assembly will be entitled to receive success-based development and commercial milestone payments. Assembly is also eligible to receive tiered royalties based on net sales. Allergan and Assembly will generally share development costs through proof-of-concept (POC) studies, and Allergan will assume all post-POC development costs.
The Assembly microbiome program consists of an integrated platform that includes strain identification and a selection process, methods for strain isolation and growth under cGMP, and a patent-pending delivery system, Gemicel, which allows for targeted oral delivery of live biologic and conventional therapies to the lower GI tract.
This transaction is expected to close in the first quarter of 2017, 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.
The deal with LTI includes the purchase by Allergan of an exclusive option right to acquire LTI. LTI’s lead program, LTI-291, aims to stimulate the activity of glucocerebrosidase (GCase) in the brain, which is reduced in several lysosomal storage diseases due to genetic mutations in the GBA1 gene. A percentage of Parkinson’s disease patients have mutations of the GBA1 gene, according to LTI. The company is studying the impact of activation of GCase by LTI-291 in the progression of Parkinson’s disease in these patients with the gene mutation.
Under the option agreement, Allergan purchased an option right directly from LTI shareholders to acquire LTI following completion of a Phase 1Ib trial for LTI-291. In addition, Allergan will provide a separate upfront research and development payment. Allergan and LTI will establish a joint development committee to oversee the development activities for LTI-291. Additional terms were not disclosed.