Allergan plc and Assembly Biosciences, Inc. announced that Allergan has entered into a research, development, collaboration and license agreement for the worldwide rights to Assembly's microbiome gastrointestinal (GI) development programmes.
The agreement provides Allergan with worldwide rights to 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 Diarrhoea (IBS-D), with Constipation (IBS-C) or Mixed (IBS-M).
Under the terms of the agreement, 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 programme consists of a fully integrated platform that includes a robust strain identification and selection process, methods for strain isolation and growth under current Good Manufacturing Practices and a patent-pending delivery system, Gemicel, which allows for targeted oral delivery of live biologic and conventional therapies to the lower gastrointestinal tract.
"The Microbiome -- the microbial populations that colonize the human body -- is rapidly gaining prominence in numerous fields of research relevant to Allergan's key areas of focus, including GI disorders," said David Nicholson, chief R&D officer, Allergan. "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."
This collaboration reinforces Allergan's commitment to building a robust portfolio through Open Science. As with most of our agreements, we enter into partnerships which, through creative structures, leverage the expertise of our partners to potentially deliver innovative treatments for improved patient care.
"Our fully-integrated microbiome platform reflects Assembly's commitment as one of the leaders in the exciting new field of microbiome therapeutics, which has the potential to address a range of diseases in entirely new ways," said Derek Small, chief executive officer of Assembly. "We are delighted to enter into this collaboration with Allergan, an innovator in GI, as we work together to realize the potential of microbiome therapies and provide treatments to patients with serious GI disorders."
"Inflammatory diseases of the GI tract, including Crohn's disease and ulcerative colitis, are debilitating conditions that remain poorly treated for many patients," said Martin J. Blaser, MD, Director of the New York University Human Microbiome Program. "Therapies leveraging the microbiome may be able to address these disorders in fundamentally new ways. I am encouraged that microbiome innovators such as Assembly and Allergan are working to convert their promising new approaches into clinically useful products to help these patients."
The 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.
Allergan plc, headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma.
Assembly Biosciences, Inc. is a clinical-stage public biotechnology company developing two innovative platform programmes: an HBV programme advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and a microbiome program developing novel oral biotherapeutics designed to address diseases associated with the microbiome.