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Pharmaceutical companies AbbVie and Eli Lilly have withdrawn from Britain's voluntary medicines pricing agreement, an industry body said on Monday. Companies are increasingly arguing that it is no longer possible to justify the UK's "voluntary scheme" to global boardrooms and investors as repayment rates in 2023 have surged to 26.5 per cent of revenue, the Association of the British Pharmaceutical Industry (ABPI) said in a statement. "The current scheme has harmed innovation, with costs spiralling out of control, and the UK falling behind other major countries to be left as a global outlier," said Laura Steele, president and general manager for Eli Lilly's Northern Europe division. ABPI said it was seeking early talks with the government to set out a new future settlement. In December, the industry body had said the government raised the amount manufacturers of branded medicines within the voluntary scheme will be required to return to almost £3.3 billion in sales revenue from an earlier amount of £1.8 billion.

An experimental Alzheimer's drug developed by Eli Lilly and Co slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. Lilly's drug, donanemab, met all goals of the trial, the company said. It slowed progression of Alzheimer's by 35% compared to a placebo in 1,182 people with early-stage disease whose brains had deposits of two key Alzheimer's proteins, beta amyloid as well as intermediate levels of tau, a protein linked with disease progression and brain cell death. The study also evaluated the drug in 552 patients with high levels of tau and found that when both groups were combined, donanemab slowed progression by 29% based on a commonly used scale of dementia progression known as the Clinical Dementia Rating Scale (CDR-SB). Using that scale, experts said Lilly's findings were roughly on par with Eisai Co Ltd and Biogen Inc's lecanemab, sold under the brand name Leqembi, which reduced cognitive decline by 27% in patients with early Alzheimer's in a study published last year. The results drove Lilly's shares to a record high, up more than 6% at $429.85. Dr. Ronald Petersen, an Alzheimer's researcher at Mayo Clinic, said Lilly's trial is the third to show removing amyloid from the brain slows progression of the disease, which could put to rest some lingering doubts about the benefits of drugs in the class and the amyloid-lowering theory. "It's modest, but I think it's real," he said of the benefit, "and I think it's clinically meaningful." Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the efficacy looks as good or better than lecanemab.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

PBR Staff Writer Published 22 April 2014 Swiss pharmaceutical firm Novartis has entered into a definitive agreement to acquire the oncology unit of Britain's GlaxoSmithKline (GSK) for about $14.5bn and up to $1.5bn contingent on a development milestone. As part of the deal, Novartis would have opt-in rights to GSK's current and future oncology R&D pipeline.

The Association of the British Pharmaceutical Industry (ABPI) on Thursday (February 2) called for the government to scrap its plans to raise the repayment rates for drugmakers, to avoid possible setbacks in the sector. Drugmakers that are part of the government's voluntary scheme agreement, which makes branded medicines affordable for people, are required to pay a part of their drug revenue to the government. The Department of Health and Social Care plans to raise the revenue clawback rate to 27.5 per cent from 24.5 per cent. The country's ongoing attempt to raise rates is likely to send the "worst possible signal" to global investors and boardrooms, said the ABPI. "Hiking these clawbacks to such uncompetitive levels risks undermining the UK's offer to global life sciences companies," Richard Torbett, chief executive of the ABPI, said in a statement. Pharmaceuticals giants AbbVie and Eli Lilly withdrew from the UK's voluntary drug pricing agreement in January after the repayment rates surged to 26.5 per cent.

Diabetes drugs that also promote weight loss such as Novo Nordisk's Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer's disease. Diabetes regimens, from Ozempic to old mainstays like insulin and metformin, appear to address several different aspects of the metabolic system implicated in Alzheimer's disease, including a protein called amyloid and inflammation, researchers say. The hope is that improving glucose utilisation and tamping down inflammation in the entire body - including the brain - could slow progression of debilitating diseases like Alzheimer's and Parkinson's. Several scientists interviewed by Reuters news agency pointed to mounting research supporting testing diabetes drugs against neurodegenerative diseases. Results are years away and success uncertain. But interest has been buoyed by recent positive data on Alzheimer's drugs developed by Eisai with partner Biogen and by Eli Lilly demonstrating that removing sticky amyloid plaques accumulated in the brain can slow cognition decline caused by the fatal mind-wasting disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs.

Denmark's Zealand Pharma and Boehringer Ingelheim said their experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial, lining up a potential contestant in the booming obesity drug market. In a statement on Wednesday (May 10), the partners said that the Phase II dose-finding trial met its primary endpoint of weight loss after 46 weeks. Paola Casarosa, head of therapeutic areas at Germany's Boehringer Ingelheim told Reuters the partners are in discussion with regulators about the design of a planned follow-up trial in the third and last phase of testing. The enormous demand for weight-loss treatments such as Novo Nordisk's Wegovy, or potentially Eli Lilly's Mounjaro, could support as many as 10 competing products with annual sales reaching up to $100 billion within a decade, mostly in the United States, industry executives and analysts said. Lilly said about a year ago that Mounjaro was shown to reduce up to 22.5% in weight after 72 weeks of treatment in a much larger late-stage trial.

National Institute of Health and Care Excellence (NICE) has not recommended 'Tirzepatide', also known as Mounjaro, developed by Eli Lilly, in its draft guidance issued on Tuesday (27 June) for treating type 2 diabetes in adults alongside diet and exercise. The independent NICE committee recognised the importance of new treatment options given that fewer than two-thirds of the adults with type 2 diabetes have adequate glucose control when using current treatment options. Evidence submitted to the committee from clinical trials showed the use of tirzepatide at any dose resulted in better glucose control and lower weight compared with semaglutide or insulin therapy. The weight reduction was more pronounced with higher doses of tirzepatide, while the effect on glucose levels seemed less dose-dependent. Similar effects were observed against all GLP-1 receptor agonists in company's network meta-analysis, but this was uncertain. The committee have asked the company to provide more data to address the uncertainties in the clinical evidence, when compared to all relevant alternative treatments.

New data on weight loss drugs that could compete with Novo Nordisk's Wegovy are raising expectations there will soon be more options, and possibly lower prices, in an estimated $100 billion marketplace, doctors and pharmaceutical executives say. Drugmakers are ratcheting up their research and aiming for new formulations that can be taken as pills, options to deliver higher weight loss or drugs that reduce fat while maintaining muscle. "It has really been an explosion of innovation," said Dr. Robert Gabbay, chief science officer at the American Diabetes Association (ADA), which receives funding from both Novo and Eli Lilly and Co and just concluded its annual meeting in San Diego, California. "If there are multiple (treatments) in the market, that will lead to some level of competition and greater access."

The National Institute for Health and Care Excellence (NICE) has recommended abemaciclib also called Verzenios, made by Eli Lilly, for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery to remove their tumour. The clinical trial result showed that people having abemaciclib with hormone therapy had a more than 30 per cent better chance of their cancer not coming back following surgery compared with people having hormone therapy alone. Helen Knight, interim director of medicines evaluation at NICE, said: "Today's positive draft recommendation, which comes less than a month after abemaciclib received its licence, is fantastic news. The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible. "Until now there have been no targeted treatments for people with this type of breast cancer. Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease."