Of all that happened in 2023, Medicare price negotiations probably top the list as the biggest U.S. biopharma disruptor. Although Congress cleared the way for the negotiations last year when it passed the partisan Inflation Reduction Act, they weren’t fleshed out until this year when the Centers for Medicare & Medicaid Services issued guidance detailing the rules of the negotiating road. And as usual, the devil is in the details.
If there is one therapeutic area for which numerous biopharma companies and investors have shown increasing amounts of interest in 2023, it is obesity through follow-on glucagon-like peptide-1 receptor agonists, as well as combination and solo efforts with other potential mechanisms. Analysts have suggested the obesity market (which includes overweight individuals) could grow to more than $50 billion by 2030. At least.
Altimmune Inc.’s peptide-based glucagon-like peptide-1/glucagon dual receptor agonist pemvidutide hiccupped in a phase I study earlier this year but has bounced back with top-line results from its phase II study in obesity. Results showed robust reductions in body mass index and serum lipids, along with improvements in blood pressure with no imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate. The data showed liver-fat loss similar to Novo Nordisk A/S’ GLP-1 drug Wegovy (semaglutide).
With drug shortages becoming a fact of life, U.S. President Joe Biden said he plans to issue a presidential determination to broaden the Department of Health and Human Services’ (HHS) authorities under the Defense Production Act to enable investment in the domestic manufacturing of essential medicines, medical countermeasures and other critical inputs that the president deems essential to the national defense.
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
More details of Novo Nordisk A/S’ phase III Select trial indicate that risk reductions in major adverse cardiovascular events were achieved regardless of age, gender, ethnicity and starting body mass index when obese and overweight patients were treated with Wegovy (semaglutide, 2.4 mg). Statistical significance was seen, however, only with the reduction of heart attacks and not other measures that were part of the trial.
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
Fake versions of Novo Nordisk A/S’ 1-mg Ozempic prefilled pens are sounding alarms in Europe amid an ongoing shortage of the company’s semaglutide products resulting from demand in the weight-management space.
Danish obesity and diabetes drugmaker Novo Nordisk A/S is set to acquire the Singapore-based KBP Biosciences Co. Ltd.’s hypertension drug, ocedurenone (KBP-5074), for potentially $1.3 billion, creating a platform to increase its reach in the cardiovascular (CV) landscape beyond a crowding obesity market.
