Enlicitide chloride

Dive Brief:Novo is investing in oral biologics, signing a deal with fellow Danish company Orbis Medicines to discover multiple macrocyclesthat have the potential to replace injectable medicines, Orbis said Thursday.Orbis could receive as much as $1.4 billion in up front and downstream payouts, as well as sales royalties, in the deal. The companies didnt specify the number of drugs on which they would collaborate, nor specific diseases, only mentioning that theyll pursue unnamed cardiometabolic targets.The use of macrocycles is one way Novo could overcome some of the limitations of standard oral peptide medicines, such as poor digestive absorption. The highest dose of Novos Wegovy pill contains 20 times the highest injectable dose because most of the drugs active ingredient is chewed up before reaching the bloodstream.Dive Insight:Biologic drugs such as peptides and antibodies are primarily delivered through infusions or injections, with subcutaneous pens being the most patient-friendly options. But drugmakers have long searched for ways to pack a biologic into a pill, hoping to help further improve convenience and medication adherence.Macrocyclic peptides, a newer twist on a well-known drug class, are one option. Merck & Co. brought such a treatment to market earlier this year when it won approval of the cholesterol lowering medication Lipfendra. A group of startups are working on other ways to advance the technology, among them Orbis,Unnatural Productsand Dayra Therapeutics. All three have now signed deals with larger drugmakers.Novo, meanwhile, is in the midst of a reboot that follows its loss of leadership in obesity and diabetes medicines to Eli Lilly. Over the last year or so, the company has swapped CEOs, laid off staffand reshuffled its board.Earlier this week, the company also announced a corporate rebranding that will see it drop Nordisk from its name in day-to-day use. Its invested heavily in AI tools, too, most recently through an alliance with Anthropic.Orbis incorporates AI into drug research as well. The company uses a platform it calls nGen to model and design molecules that are both orally bioavailable and capable of modulating challenging intra- and extracellular targets, the company said.Orbis launched with $93 million in January 2025.Editors note: This story has been updated to clarify the name of Orbis platform. '

A new analysis of Amgen's Phase III VESALIUS-CV trial has found that its cholesterol-lowering drug Repatha (evolocumab) nominally reduced the risk of death by 20% in high-risk patients who had not previously experienced a heart attack or stroke.According to Amgen, that makes Repatha the first PCSK9 inhibitor shown to lower overall mortality risk, including risk for heart-related death, in a Phase III trial of primary prevention patients. Findings from the pre-specified secondary analysis of VESALIUS-CV were presented at the European Society of Cardiology (ESC) congress, and published simultaneously in Circulation on Monday."For people at high risk of a heart attack or stroke, lowering LDL-C or 'bad' cholesterol with Repatha may do more than help prevent these events; it may also reduce the risk of dying from heart disease and its serious consequences," said Jay Bradner, EVP, R&D, AI and data at Amgen.Case for earlier treatmentVESALIUS-CV enrolled more than 12,000 adults at high cardiovascular (CV) risk — either those with known atherosclerotic disease or high-risk diabetes — but who had no history of heart attack or stroke. Participants also had elevated cholesterol markers and were treated with the highest tolerated dose of statin and/or ezetimibe.Over a median 4.6 years of follow-up, nearly 8% of patients died; 36% were from CV causes, 51% from non-CV causes, and the rest from causes that couldn't be determined. Patients taking Repatha were significantly less likely to die from any cause than those on placebo (7.9% vs. 9.7% over the follow-up period; HR 0.80, p=0.0005). The mortality benefit emerged after about 1.5 years of treatment and continued through follow-up.The mortality findings build on the main VESALIUS-CV results, which were published in NEJM last year. In that analysis, Repatha reduced the risk of a composite of coronary heart disease death, heart attack or ischaemic stroke by 25%, while a broader composite including ischaemia-driven revascularisation fell 19% (see – Spotlight On: Amgen's Repatha posts big primary prevention win – but big enough?).Amgen said additional analyses presented at ESC showed reductions in first, subsequent and total CV events, with a reduction in first heart attacks being seen as early as six months after treatment with Repatha started. The risk reduction was mainly due to fewer heart attacks caused by ruptured atherosclerotic plaques, and fewer larger infarctions."The totality of these data is practice-changing and reinforces the importance of identifying high-risk patients early and lowering LDL-C aggressively and consistently with Repatha," Bradner said.Push into primary preventionMonday's findings could bolster Amgen's push to move intensive lowering of LDL-C earlier in the CV disease pathway, as the company looks to extend the commercial runway of a drug that was first approved more than a decade ago.That strategy likely matters even more now with the recent FDA approval of Merck & Co.'s Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor, which offers patients a pill-based alternative to injectable therapies (see – Spotlight On: Updated Physician Views poll data shows particularly strong support for Merck & Co.'s Lipfendra from US cardiologists and Physician Views Results: Novartis' Leqvio well positioned, but oral PCSK9 threat is real).Repatha, which generated about $3 billion in sales last year, had its label expanded in 2017 to include secondary prevention.