Protocols

Pfizer’s Ixifi gets approved as third Remicade biosimilar; Novo Nordisk licenses reMYND’s diabetes program in potential €350M deal

→ A third knockoff is coming after J&J’s Remicade as the FDA approved Pfizer’s $PFE monoclonal antibody Ixifi for a list of indications including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Pfizer submitted a BLA in April, following the launch of its first Remicade biosimilar — Inflectra, picked up when the pharma giant acquired Hospira — in October of 2016. Also in April: Samsung Bioepis got the green light for its own copycat Renflexis, which it went on to sell at 65% of J&J’s list price. Given that Pfizer only offered a 15% discount on Inflectra,the pricing of this new drug will likely be closely watched.

Novo Nordisk $NVO has inked a diabetes deal with Belgium’s reMYND, promising up to €350 million in research and milestone payments (as well as unspecified royalties) for rights to the ReS39 program. The program focuses on compounds that boosts the pancreas’ insulin production capacity by restoring beta-cell function and insulin signalling in Type 1 and Type 2 diabetes. That’s something that reMYND’s team has observed in animal models; they believe the program also has potential in NASH and the metabolic syndrome. “Even though symptomatic treatments work well, diabetes patients would greatly benefit from restoring durably their endogenous insulin production and/or increasing insulin sensitivity,” reMYND managing director Koen De Witte said in a statement. “Novo Nordisk’s agility to step-in once they observed the effects of our ReS39 treatment in their own hands makes the road ahead all the more exciting.”

→ The FDA has accepted Bristol-Myers Squibb’s  application for a combination of Opdivo and Yervoy for advanced renal cell carcinoma to the FDA. The agency has already handed out a breakthrough therapy indication for this one, which pairs the company two big checkpoint drugs. Bristol-Myers stopped their late-stage study CheckMate-214 early after tracking positive results.

→ Belgium’s argenx $ARGX has raised $231 million from the sale of stock.


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