Merck & Co. Inc., building on a year-old deal with Aligos Therapeutics Inc., has moved to in-license an early stage nonalcoholic steatohepatitis (NASH) oligonucleotide program Aligos had previously advanced independently. The amended deal also gives Merck the right to add a new NASH target to the partnership, in addition to those already part of the agreement. With Aligos eligible to receive up to $460 million in development and commercialization milestones as well as tiered royalties on net sales per target, its rewards could reach $1.38 billion.
The deals continued to flow during day two of the J.P. Morgan Healthcare Conference. Privately held Arrakis Inc., which specializes in aiming at small-molecule RNA targets, primarily cancers, has signed onto a collaboration with Amgen Inc. that could bring in billions in future payments should it hit all the milestones and program options are exercised. Dren Bio Inc., meanwhile, will collaborate with Pfizer Inc. to develop bispecific antibodies for oncology targets. Dren could receive more than $1 billion in the deal that includes a $25 million in cash up-front payment from Pfizer.
Digital health innovation was front and center at this year’s Consumer Electronic Show (CES) in Las Vegas. The four-day event included a major product announcement from Abbott Laboratories and a keynote presentation delivered by CEO Robert Ford. This marked the first time a health care company has been invited to take the main stage.
A raft of potentially high-value drug development collaborations, most for gene and RNA therapies, led the first day of the 40th Annual J.P. Morgan Healthcare Conference Monday. Pfizer Inc. enlisted Beam Therapeutic Inc. to advance in vivo base editing programs for up to $1.35 billion, while Bayer AG tapped Mammoth Biosciences Inc.’s in vivo CRISPR systems expertise in a potential $1 billion-plus deal. Selecta Biosciences Inc. inked a new $1.1 billion partnership with Ginkgo Bioworks Inc. to develop next-generation gene therapy capsids, while Acadia Pharmaceuticals Inc. agreed to pay Stoke Therapeutics Inc. as much as $967 million to develop RNA-based medicines. Work on new mRNA vaccines and therapies is also proceeding, with both Pfizer and Biontech SE announcing new collaborations in the space.
The Verifying Accurate Leading-edge IVCT Development (VALID) Act seems poised for passage in 2022, a bit of welcome relief for those stuck in the regulatory twilight world of the lab-developed test (LDT). However, Carly McWilliams, director of regulatory policy for North America for Roche Inc., said recently at the recent Food and Drug Law Institute enforcement meeting that the VALID Act is likely to leave the question of a user fee schedule for a future Congress, given that the associated rulemaking, guidance development and compliance activities are likely to consume the better part of, if not the entirety of, the next five years.
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