Promising early data details on Amgen weight-loss drug published

 Animal and early-stage human trial data for Amgen's experimental obesity drug published in a medical journal showed that it promoted significant weight loss with an acceptable safety profile, the company said on Monday.

The dataset published in Nature Metabolism details outcomes and adverse events for the 49 patients in the Phase 1 trial of the drug, maridebart cafraglutide. Trial participants received different doses of the drug ranging from 21 milligrams to 840 mg. Patients in the study were obese, but did not have other underlying health conditions such as diabetes.

The most common treatment related side effects were nausea and vomiting. One patient given a single 140 mg dose of the drug experienced elevated levels of pancreatic enzymes, as did another patient treated with 140 mg in the multiple dose group.

Amgen said the injected drug, also known as MariTide, links a compound designed to activate the GLP-1 hormone associated with a feeling of fullness to an antibody that blocks activity of a different gut hormone, GIP, that has been linked to fat storage and metabolic regulation.

The company first announced in late 2022 that the Phase 1 clinical trial showed that at the highest monthly dose tested, given for 12 weeks, the drug led to mean loss of 14.5% of body weight and that patients maintained that for 70 days.

Those findings are especially noteworthy given data that has since emerged showing that patients on current popular treatments like Eli Lilly's Zepbound and Novo Nordisk's Wegovy quickly gain weight back after stopping treatment, said Narimon Honarpour, Amgen's head of global clinical development.

"Our data has not changed, but the context probably has," he said.

Four out of eight participants in the 420 mg segment of the multiple-dose cohort dropped out of the study after their first dose. Amgen said it appeared those patients did not want to continue participating in a clinical trial, and that there was no indication they had experienced adverse events beyond those seen with other participants.

Levels of HbA1c, a measure of blood sugar, were in the non-diabetic range at the beginning of the trial, decreased in all dose groups by day 85, but trended back toward baseline during the safety follow-up period at day 207, the researchers reported.

Amgen is currently conducting a Phase 2 trial of MariTide with results expected late this year.

https://finance.yahoo.com/news/promising-early-data-details-amgen-100000315.html

Novo Nordisk acquiring Catalent to expand, meet GLP-1 demand

 Novo Nordisk A/S agreed to buy three manufacturing plants for $11 billion to help it meet surging demand for the obesity drug Wegovy and diabetes shot Ozempic.

Novo is paying its main shareholder, Novo Holdings A/S, in cash for the fill-finish sites. Novo Holdings on Monday agreed to buy the owner of the assets, Catalent Inc., in a deal with an enterprise value of $16.5 billion. The transactions are the largest ever for both Danish companies.

Catalent shares rose as much as 9.8% in New York. Novo shares, which have been soaring alongside demand for its drugs, gained as much as 3.8% on the news, touching a record. The drugmaker is Europe’s most valuable company with a market capitalization of more than $520 billion.

Novo Nordisk is under pressure to increase its supply of Wegovy as it faces competition from Eli Lilly & Co.’s recently approved Zepbound shot, which is predicted to become the best-selling drug in history. In patient trials, Lilly’s drug led to more weight loss than anything Novo has put out to date.

Read More: Eli Lilly’s $600 Billion Weight-Loss Empire Was Late, But Lucky

The acquisition of factories in Italy, Belgium and Indiana isn’t an immediate fix for Novo’s production problems. It will gradually increase manufacturing capacity from 2026 and onward, according to a spokeswoman. Production has been a thorn in the Danish drugmaker’s side even as it profits from the new class of obesity drugs it helped pioneer.

There are “clear business reasons for Novo Nordisk to acquire these three manufacturing plants in order to speed up supply of key products - not least Wegovy,” Brian Borsting, a credit analyst with Danske Bank A/S, said in a note to clients.

The deal for Catalent has the backing of Elliott Investment Management, the activist investor, which has a stake in the US company. The agreement is worth $63.50 per share in cash, a 17% premium to Catalent’s Friday close, according to a statement.

Catalent had drawn takeover interest from other market players as well. Last year life sciences company Danaher Corp. expressed interest. Based in Somerset, New Jersey, the contract manufacturer gained prominence during the Covid-19 pandemic as a producer of vaccines and treatments.

https://finance.yahoo.com/news/novo-buys-three-plants-11-122310173.html

BridgeBio: NDA OKd for Acoramidis for Treatment of Transthyretin Amyloid Cardiomyopathy

 Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application

- Marketing Authorization Application accepted by the European Medicines Agency (EMA) with additional global regulatory submissions planned

- In ATTRibute-CM, acoramidis treatment demonstrated an 81% absolute survival rate and a 0.29 observed mean annual cardiovascular-related hospitalization (CVH) frequency, as well as improvements for a large proportion of patients on laboratory and functional measures

- ATTRibute-CM results also demonstrated rapid clinical benefit on the composite endpoint of all-cause mortality (ACM) and CVH in patients treated with acoramidis, with time-to-first event Kaplan-Meier curves separating at month 3 and continuing to diverge steadily through Month 30

https://www.globenewswire.com/news-release/2024/02/05/2823433/0/en/BridgeBio-Pharma-Announces-U-S-Food-and-Drug-Administration-FDA-Acceptance-of-New-Drug-Application-NDA-for-Acoramidis-for-the-Treatment-of-Patients-with-Transthyretin-Amyloid-Cardi.html