Eli Lilly and Co. is paying $13.5 million to bow out of a class action lawsuit that claimed the list price of several insulin analogue products was fraudulent. Lilly also committed to capping the monthly patient out-of-pocket cost at $35 for its insulin products for at least four years, bringing the total value of the settlement, announced May 26, to more than $500 million, according to the attorneys who filed the class action on behalf of patients in 2017.
Scribe Therapeutics Inc. is selling exclusive rights to its CRISPR-based technology to Prevail Therapeutics Inc. for a figure that could top $1.6 billion as the firms team up to develop genetic therapies for serious neurological and neuromuscular diseases.
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
In January, a Wall Street analyst predicted the U.S. FDA’s rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, would be a “mere footnote” in the drug’s development, a forecast confirmed in the wake of positive top-line phase III data showing donanemab significantly slowed cognitive and functional decline in people with early symptomatic disease.
Positive phase III results from Surmount-2 of Eli Lilly and Co.’s Mounjaro (tirzepatide) showed overweight and obese type 2 diabetes patients receiving the highest dose lost up to 34.4 pounds, with the majority achieving at least a 5% decrease in overall body weight. The results will help the Indianapolis-based company complete its rolling supplemental NDA with the U.S. FDA targeting an approval for obese and overweight adults with weight-related co-morbidities.
Eli Lilly and Co. is selling worldwide rights to its hypoglycemia nasal treatment Baqsimi to Amphastar Pharmaceuticals Inc. in a deal potentially worth over $1 billion. Under the agreement, Amphastar, of Rancho Cucamonga, Calif., will foot a $500 million cash payment on closing, and will pay Indianapolis-based Lilly an additional $125 million on the one year anniversary of closing. Lilly is also eligible to receive milestone payments of up to $450 million, based on annual sales of $175 million and $200 million, and on total net sales over five years of $950 million.
Manufacturing deficiencies stand in the way of two BLAs as complete response letters (CRLs) were issued to Eli Lilly and Co. and to Alvotech Holdings SA. The U.S. FDA issued the CRL to Lilly regarding the BLA for mirikizumab, a humanized IgG4 monoclonal antibody to treat ulcerative colitis, specifically citing manufacturing concerns. There’s a similar problem with Alvotech’s biosimilar candidate for Abbvie Inc.’s Humira (adalimumab). The FDA issued a CRL for AVT-02’s BLA, citing problems needing resolution at its Reykjavik, Iceland, manufacturing facility before it could approve the application.
Eli Lilly and Co. has described aryl hydrocarbon receptor (AhR) agonists reported to be useful for the treatment of psoriasis, ulcerative colitis, Crohn’s disease, graft-vs.-host disease and multiple sclerosis.
