Eli Lilly Archives - Medical Design Sourcing

GLP-1 drugs could open a new frontier in NASH treatment

[Adobe Stock]

This morning, Eli Lilly reported positive phase 2 results for its dual GLP-1 and GIP receptor agonist tirzepatide in patients with nonalcoholic steatohepatitis (NASH). In the SYNERGY-NASH trial, the therapy achieved NASH resolution without worsening fibrosis in 61.3% of patients. That is considerably higher than data for semaglutide.

Picturing tirzepatide’s NASH resolution in a phase 2 study

The bar graph below depicts the proportion of participants showing no worsening of liver fibrosis at 52 weeks with varying doses of tirzepatide compared to a placebo in the SYNERGY-NASH phase 2 study. See page 17 here for the data source.

google.charts.load('current', {packages: ['corechart', 'bar']}); google.charts.setOnLoadCallback(drawChart); function drawChart() { var data = google.visualization.arrayToDataTable([ ['Treatment', 'Perc…

Pharma manufacturing sees wave of investments in Europe

[Adobe Stock]

Over the past three months, the pharma sector has seen a string of investments in manufacturing facilities, especially in Europe. While the European economy lost momentum in 2023 owing to a high cost of living, weak external demand, and monetary tightening, the prospects for growth remain stronger with the EU GDP growth forecast to improve to 1.3% in 2024, according to the European Commission. As economic prospects improve in 2024, major pharma companies are doubling down on investments in European manufacturing infrastructure and jobs to meet strong global demand. While the sector regains momentum, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed concerns about a proposed overhaul of pharma rules from the European Commission, which it worries could harm future investments in the region. For the time being, major pharma companies including Novo Nordisk, Eli Lilly…

Eli Lilly’s Mounjaro sees explosive sales growth, yet demand outpaces supply

Eli Lilly’s diabetes medication Mounjaro (tirzepatide) is seeing explosive sales growth, jumping from $187.3 million in the third quarter of 2022 to $1.4 billion in the same period this year. Conversely, sales of Lilly’s Trulicity, another diabetes drug, have declined, dipping from $1.85 billion in Q3 2022 to $1.67 billion in Q3 2023.

Mounjaro is selling so briskly that Lilly is having trouble making enough of it. The company is aiming to boost supply by recruiting a diverse portfolio of contract manufacturers. It plowed $450 million in its Research Triangle Park facility in North Carolina to support additional drug filling, device assembly, and packaging capacity. It also invested an additional $1.6 billion in new manufacturing sites in its home state of Indiana. Despite the efforts, the company notes that supply problems have led to “intermittent delays” in filling orders and tight supply of the medication throughout most of the third quarter…

Mirikizumab shows continued promise for ulcerative colitis after regulatory hiccup

Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were intolerable.

In April, the company announced that it had received a complete response letter for mirikizumab for UC as a result of issues FDA identified related to the proposed manufacturing of the antibody. The agency noted no concerns about the clinical data package, safety, or label for the therapy.

After revealing the most recent LUCENT-3 data, Lilly plans on filing a marketing application for mirikizumab in Crohn’s disease to FDA. It intends to file paperwork with other regulatory agencies in 2024.

Mirikizumab efficacy in LUCENT-3

The LUCEN…

Eli Lilly’s obesity focus helps propel promising 2023

2023 is shaping up to be a blockbuster year for Eli Lilly. With the company’s stock soaring by almost 54% since the beginning of the year, analysts are largely upbeat about Lilly’s expanded focus on obesity and diabetes treatments. While the company has developed insulin for a century, the company is now broadening its horizons with Mounjaro (tirzapetide), a diabetes treatment used off-label for obesity. An FDA approval for tirzapatide, a dual GLP-1/GIP receptor agonist, in obesity could occur later this year.

While Lilly has seen its stock surge in 2023 thus far, its performance over the past month hasn’t been as robust — declining by close to 6% over the past month.

Momentum

“We continue to be pleased with the strong momentum of Mounjaro as more type 2 diabetes patients benefit from the medicine,” said Dave Ricks, chairman and CEO of Eli Lilly, in the company’s second quarter earnings call. In fact, despite ramping up produ…

Lilly acquires Point Biopharma amid third FDA rejection in 2023

Eli Lilly and Company has recently received its third FDA rejection for the year 2023. The most recent came for lebrikizumab, the company’s investigational treatment for atopic dermatitis. FDA made the decision following an inspection of a third-party contract manufacturing organization. The agency had no complaints concerning the clinical data, safety, or labeling of lebrikizumab, but instead focused on quality control deficits.

Setbacks earlier in the year

Before the lebrikizumab setback, Lilly faced rejections for another antibody, mirikizumab, intended for ulcerative colitis. Donanemab, its Alzheimer’s disease was also affected. The former’s rejection also stemmed from manufacturing-related issues, while the latter faced concerns regarding the limited patient exposure during clinical trials.

Despite the hurdles, Lilly has fared extremely well on the stock market in 2023. Its share price is up more than 40% so far in 2023, trading most recently at $517…

The weight-loss drug market: overhyped or justified?

Photo by John Guccione www.advergroup.com: https://www.pexels.com/photo/100-us-dollar-banknotes-3531895/

The obesity drug market has seen a surge of interest recently, largely thanks to the popularity of glucagon-like peptide-1 (GLP-1) drugs like Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro. The explosion in interest in the drug class has fueled the stock prices of Novo and Lilly, which both have multiple GLP-1 drugs in their portfolios.

Novo’s stock on the New York Stock Exchange is up over one-third so far in 2023 — trading near $92 per share after beginning the year at $68.48. Lilly has seen even steeper gains with its stock closing at $538.29 on October 2, up almost 48% so far this year.

So far this year, the GLP-1 surge has negatively impacted the stocks of some medical device companies focused on diabetes and sleep apnea. Analysts have even speculated that the surge in popularit…

Lilly wraps up acquisition of Versanis, marking the fifth largest pharma deal of 2023

Top 5 biggest M&A deals in the pharmaceutical industry as of August 14, 2023: Pfizer/Seagen ($43B), Biogen/Reata Pharmaceuticals ($7.3B), Astellas Pharma/Iveric Bio ($5.9B), Merck & Co./Prometheus Biosciences ($10.8B), Eli Lilly/Versanis ($1.93B).

Eli Lilly just wrapped up its acquisition of Versanis Bio in a $1.9 billion deal, the pharma giant announced today. The deal marks Lilly’s latest move to build up its pipeline of potential obesity and diabetes treatments, which promises to be a notable growth area for the company. Lilly recently completed its submission of tirzepatide for chronic weight management to the FDA.

The company reported positive Phase 3 results from the SURMOUNT-3 and SURMOUNT-4 studies, showing the highest levels of weight loss observed so far in the SURMOUNT program.

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1…

Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%

According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries.

Another monoclonal antibody, Leqembi (lecanemab) recently won FDA approval for Alzheimer’s disease treatment after showing a statistically significant 27% reduction in decline on the Clinical Dementia Rating Scale in trials.

Donanemab is an investigational plaque-clearing antibody similar to lecanemab and aducanumab, which controversially notched FDA approval in 2021 based on its plaque reduction despite inconsistent clinical efficacy data.

A look at TRAILBLAZER-ALZ 2

The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that donanemab, an investigational drug, significantly slowed cognitive and fun…

Eli Lilly to acquire cardiometabolic disease treatment maker Versanis for $1.925B

Eli Lilly (NYSE:LLY) announced today that it entered into a definitive agreement to acquire Versanis, a private, clinical stage biopharmaceutical company.

Versanis focuses on the development of new medicines for the treatment of cardiometabolic diseases. Its lead asset, bimagumab, is a monoclonal antibody. Bimagumab binds activin type II A and B receptors to block activin and myostatin signaling. The company currently has it under assessment in the BELIEVE Phase 2b study alone and in combination with semaglutide. It aims to treat overweight or obese adults.

According to a news release, combining incretins with bimagrumab could potentially reduce fat mass while preserving muscle mass. It may lead to better outcomes for people with obesity and obesity-related complications.

“Lilly is committed to investigating potential new medicines to fight cardiometabolic diseases, including obesity, a chronic disease that affects over 100 million Americans,”…

The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies were part of some of the biggest stories from the American Diabetes Associations’ 2023 Scientific Sessions. [Images courtesy of Insulet, Medtronic and Senseonics]

As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space.

At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for a number of technologies and innovations. From continuous glucose monitors (CGMs) to insulin pumps to digital platforms and diabetes reversal procedures, ADA 2023 saw it all.

Usual suspects, like Dexcom, Abbott, Medtronic and Insulet shared their updates. Meanwhile, promising data came …

The battle of the bulge: Semaglutide and tirzapatide could be new weight-loss warriors

[Image courtesy of New Africa/Adobe Stock]

A pair of weight-loss drugs — semaglutide and tirzapatide — could reshape the way we view and treat obesity, according to a Moody’s report dated May 18. The ratings firm notes that Novo Nordisk could benefit from a first-mover advantage in the obesity market as it now has two novel weight loss drugs on the market: Saxenda (liraglutide) and Wegovy (semaglutide). Semaglutide has already emerged as an example of a ‘viral’ drug, as Harvard Health Publishing noted earlier this year, owing to its popularity on social media and with celebrities. A YouGov survey found that 60% of Americans had heard about this class of weight loss drugs.

If Lilly’s tirzepatide, the first dual GIP/GLP- coagonist, wins approval for obesity, its developer could also profit handsomely. In April, analysts projected that annual tirzepatide sales could hit $50 billion by 2030.

Tirzapa…