Eli Lilly & Co. Ltd.

LAS VEGAS — FDA Commissioner Robert Califf criticized pharma companies on Monday for charging high prices for weight loss drugs. Califf called the profit margin in the US for the drugs “outrageous.” “They should be ashamed of themselves for what they’re charging Americans,” he said on stage at the HLTH conference in Las Vegas. “It’s not right.” Califf, who’s previously called out high drug prices , said the weight loss and diabetes medication shortages were — to his knowledge — the first time a company was unable to produce enough of a drug sold at a high, profitable price point to meet the demand. Semaglutide is currently in shortage, while the FDA in October took tirzepatide off its shortage list . In the US, list prices for one-month supplies of the popular weight loss medications Wegovy (made by Novo Nordisk) and Zepbound (made by Eli Lilly) are upwards of $1,000 a month . Many patients pay less with insurance rebates and coupons. Lawmakers have scrutinized the price of GLP-1 medications, bringing Novo Nordisk’s CEO in front of a Senate hearing, where he turned the discussion toward pharmacy benefit managers who negotiate based on the list price. (This story is from our Health Tech newsletter. If you’d like to sign up, just click here .)

iStock, ktsimage Roche drops a third Alzheimer’s candidate this year, terminating a partnership with UCB just four years after agreeing to work together on new treatments for the neurological disease. Roche has cut short a partnership with UCB in Alzheimer’s disease, handing rights to a Phase IIa prospect back just over four years after signing the deal. This is the second time this year that Roche has cut an Alzheimer’s partnership, after sending two failed assets back to AC Immune in January. UCB and Roche’s Genentech unit agreed in July 2020 to develop bepranemab, then known as UCB0107, for $120 million upfront and up to $2 billion in potential milestones. The end of the partnership was revealed as UCB announced the acceptance of an abstract for a Phase IIa study of bepranemab at the 2024 Clinical Trials on Alzheimer’s Disease Meeting scheduled for Spain later this month. UCB said that the rights to the drug had been handed back after the termination of the agreement with Roche. No further details were provided. Roche listed bepranemab as headed for a regulatory filing in 2027 or beyond as of its first quarter earnings presentation in April. The therapy was not featured in the company’s second quarter earnings presentation at the half year. Roche has long been in the hunt for the next Alzheimer’s treatment but fell way behind when its late-stage candidate gantenerumab failed a pair of Phase III trials in 2022. Meanwhile, peers Eisai/Biogen and Eli Lilly have charged ahead with their groundbreaking new anti-amyloid antibodies Leqembi and Kisunla , the first new treatment options for Alzheimer’s disease in years. Back to the drawing board, Roche is developing several early-stage assets for the disorder. Until today, bepranemab was among them. That leaves RG6289 and trontinemab, which are both in Phase II. Roche showcased promising Phase Ib/IIa data for trontinemab in March, suggesting the treatment had a “rapid and robust” impact on amyloid plaque reduction. Roche’s announcement about the end of its UCB collaboration comes days after Johnson & Johnson trimmed a candidate for Alzheimer’s disease agitation or aggression.

Genevant LNP technology will provide a vehicle for Editas’ CRISPR/Cas12a gene therapy. Credit: ART-ur / Shutterstock. Editas Medicine and Genevant Sciences will collaborate to develop gene editing therapies, employing their respective CRISPR and LNP technologies under a nonexclusive licencing agreement. Cambridge, Massachusetts-based Editas will combine its CRISPR/Cas12a gene editing system with the lipid nanoparticle (LNP) technology of Genevant, based in Basel, Switzerland. The technological merge is intended to produce in vivo gene editing medicines targeting two undisclosed targets, in line with Editas’ therapeutic strategy of genetic upregulation. The agreement stipulates that Genevant grant Editas a nonexclusive, worldwide licence to the products that come from their collaboration. In return, Genevant is eligible to receive up to $283m in upfront and milestone payments, along with royalties on future sales. Dr. Linda Burkly and Dr. James Heyes, CSOs of Editas and Genevant, respectively, both expressed the complementary fit between their companies’ technologies. The announcement was met with increased trading of Editas stock as over 4.5 million shares swapped hands that day, up from just over 860,000 traded at market close the previous Friday (18 October). The company’s market cap currently stands at $310m. See Also: World Osteoporosis Day calls for urgent action to prevent fragility fractures MangoRx hits back at Eli Lilly’s weight loss drug copycat claims In the last few years, Editas has since entered into licencing deals to balance its finances; in December 2023 it licenced its technology to Vertex for $100m, and in October 2024 traded part of the revenue from this deal to a subsidiary of DRI Healthcare in return for a $57m payment. Amongst the licences traded was one concerning Casgevy (exagamglogene autotemcel), the world’s first CRISPR-based gene therapy . The asset, approved to treat sickle cell disease and beta thalassaemia, is projected by GlobalData to generate an annual $857m for Vertex by 2030. GlobalData is the parent company of Pharmaceutical Technology . Editas’s current lead candidate, renizgamglogene autogedtemcel, is a CRISPR/Cas12a-based therapy in a Phase III trial for sickle cell disease (NCT04853576) and a Phase II trial for beta thalassaemia (NCT05444894). The therapy gained orphan drug designations for both indications from the US Food and Drug Administration (FDA) in 2023. Genevant has also licenced its LNP technology to others. In July 2018 it collaborated with BioNTech to develop rare disease therapies, and in March 2022 agreed a collaboration with Takeda Pharmaceutical to develop gene therapies for liver disease. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy