Novo to Develop Obesity Drug Injected Every 1-3 Months; Acadia Alzheimer’s Drug Stumbles

Novo Nordisk is moving to develop a long-acting obesity treatment administered once every 1-3 months.

According to BioPharma Dive on the 24th (local time), Novo Nordisk secured rights to manufacturing technology for long-acting injectable drugs by agreeing to pay Swedish biotech company Nanexa up to about 1.165 billion euros (about 1.5611 trillion won).

Novo Nordisk plans to use the “PharmaShell” technology in up to five development programs for obesity, type 2 diabetes and other cardiometabolic diseases.

The companies will study formulations with different dosing intervals, aiming to develop drugs that can be administered just once a month or once a quarter. Nanexa will receive 615 million euros in upfront and future milestone payments. Nanexa also signed a similar agreement with Moderna last year.

Acadia Pharmaceuticals has decided to continue developing its experimental Alzheimer’s disease treatment. According to the company, the drug “remlifanserin” “narrowly missed” statistical significance in a Phase 2 trial evaluating its use to treat hallucinations and delusions in patients with Alzheimer’s disease psychosis.

Based on the narrow miss, other efficacy findings and a “favorable safety profile,” Acadia decided to continue enrollment in two ongoing Phase 3 trials.

Stifel analyst Paul Matteis wrote, “The debate will be whether the drug still has a chance of succeeding in these studies,” adding, “In our view, it still does.” However, he noted that the midstage trial was “highly powered” and that the efficacy results “look fairly modest.” Acadia shares fell by double digits that day.

Nektar Therapeutics prevailed in a legal dispute with its development partner, Eli Lilly. Nektar filed suit in 2023, alleging that Lilly had hindered a jointly developed autoimmune drug candidate after acquiring a competing treatment.

A federal jury in California ruled in Nektar’s favor on the 24th, but set damages at $90 million (about 120.6 billion won), far below the roughly $1 billion Nektar had sought. Nektar said in a regulatory filing that the verdict is subject to post-trial proceedings.

The U.S. Food and Drug Administration (FDA) approved a once-weekly insulin developed by Lilly on the 24th. The drug, to be marketed as “OnceWik,” was approved for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes.

In clinical trials, OnceWik was equivalent to commonly used daily injections in maintaining blood glucose levels. The approval follows the FDA’s approval in March of Novo Nordisk’s competing once-weekly insulin, “Awiqli.”

The FDA also expanded the approved use of Merck’s kidney cancer drug “Welireg” that day. Welireg, acquired in 2019, generated $470 million in sales in the first half of the year.

The latest approval covers use in patients whose kidney cancer has recurred after treatment with Keytruda. It comes two months after the FDA approved Welireg in the adjuvant setting after surgery.