Licensing Deals Struck for Liver Disease and IBD Treatments
Licensing deals are part of the life’s blood of many biotech companies as they seek to expand their therapeutic offerings and bolster pipelines. This morning two companies announced deals that will yield potential benefits to multiple patient populations.
Aerpio and Gossamer – Aerpio Therapeutics and Gossamer Bio forged an agreement worth up to $420 million, to develop and commercialize Aerpio’s HIF-1 alpha stabilizer, AKB-4924, as well as other related compounds. AKB-4924 (which will now be known as GB004) is an investigational hypoxia-inducible factor-1 alpha (HIF-1 alpha) stabilizer. It is being developed for inflammatory bowel disease. GB004, unlike other HIF stabilizers in development, preferentially stabilizes HIF-1 alpha. In animal models of IBD, GB004 has had “profound anti-inflammatory and mucosal wound healing effects”
Based on pre-clinical study results, GB004 has demonstrated several potential advantages over existing therapies for the treatment of IBD, including a possible superior efficacy and safety profile and once-daily oral route of administration, the companies said in their joint announcement. In May 2018, Aerpio initiated a 24-subject, Phase I, multiple ascending dose study to further assess the pharmacokinetics, safety and tolerability of GB004 in healthy volunteers.
Under the terms of the license agreement, Gossamer will pay Aerpio $20 million up front, with a potential $400 million in regulatory and sales milestones. Gossamer will be responsible for the remaining development, regulatory, and commercialization expenses for GB004.
BioTime and Goliver – France-based Goliver Therapeutics struck a licensing deal with California-based BioTime for a pluripotent cell line. Adi Mohanty, Co-CEO of BioTime, said the French company will use the cell line to develop therapies for liver disease, although what the target will be was not disclosed in the announcement.
The potential applications of our pluripotent cell technology are immense. Various cell lines of ours are being used by researchers around the world. We are happy to enable companies, like Goliver, which are advancing therapeutic candidates in areas that are not a core focus of BioTime’s own development efforts,” Mohanty said in a statement.
Not only was the particular therapeutic target hidden from the announcement, the financial terms of the deal were also undisclosed. BioTime did not that the licensing deal included an upfront payment, potential development milestone payments and royalties on sales of commercialized products.
California-based BioTime’s cell/drug delivery programs are based upon its proprietary HyStem cell and drug delivery matrix technology. HyStem was designed, in part, to provide for the transfer, retention and/or engraftment of cellular replacement therapies, the company said.