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Novo Nordisk to boost GLP-1 capacity with €2.1 billion investment in France

Novo Nordisk announced last week that it plans to invest approximately 16 billion Danish kroner €2.1 billion in GLP-1 drug production.

The company plans to expand its Chartres, France, production site for its current and future product portfolio within serious chronic diseases. This investment significantly increases the capacity of the manufacturing site. It adds aseptic production and finished production processes and extends its current quality control laboratory.

Denmark-based Novo Nordisk’s investment doubles the footprint of the existing plant. It began construction projects and expects finalization between 2026 and 2028, with more than 500 new jobs set to come along with it.

The company said its investment ups the capacity for GLP-1 products and will help it meet future demands for innovative medicine.

GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and weight loss. This therapeutic class, a glucagon-lik…

Novo Nordisk stops once-weekly semaglutide kidney outcomes trial early following interim analysis

Novo Nordisk will halt the phase 3b FLOW trial, which investigated the effects of once-weekly injectable semaglutide on kidney outcomes in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD).

The company reached the decision following the recommendation of the independent Data Monitoring Committee (DMC), following an interim analysis that met pre-specified criteria for stopping the trial early for efficacy. The company noted that it would maintain the integrity of the trial data, blinding to the results until the trial’s completion. It plans on announcing results in the first half of 2024.

Semaglutide Sales: 2022 vs H1 2023 google.charts.load('current', {'packages':['corechart']}); google.charts.setOnLoadCallback(drawChart); function drawChart() { var data = google.visualization.arrayToDataTable([ ['Drug Name with Brand', '2022 Sales', 'H1 2023 Sales'], …

An overview of the GLP-1 landscape in obesity therapeutics

[Feng Yu/Adobe Stock]

The GLP-1 drug market continues to boom lately thanks to highly effective new medications like Novo Nordisk’s Wegovy and continued demand for the drug class in diabetes. The runaway success of Wegovy and Ozempic (both formulations of semaglutide) has caused Novo Nordisk’s share price to skyrocket in 2023, briefly making the Danish pharmaceutical company the most valuable in Europe by market capitalization. Novo Nordisk’s growth has even exceeded Denmark’s entire economic output.

Far-ranging GLP-1 landscape projections

Given the massive potential of the obesity drug market, with projections ranging from Goldman Sachs’ $44 billion to Barclays’ $100 billion by 2030, Big Pharmas such as Novo Nordisk and Lilly are engaging in billion-dollar acquisitions of smaller biotechs with promising obesity pipelines.

At present, Novo Nordisk is having troubling ke…

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…

White House targets blockbusters in Medicare’s price negotiation strategy

Photo by Tabrez Syed on Unsplash

The Biden-Harris Administration has nominated 10 drugs for price negotiations directly with pharmaceutical giants after capping monthly insulin costs at $35.

Americans have historically paid more for prescription drugs than most other major economies. In a fact sheet, the White House highlighted that seniors paid $3.4 billion in out-of-pocket costs for these drugs just last year. Biden, like Trump before him, aim to bring prices more in line with those of other advanced nations.

This move is not isolated. The Biden Administration has implemented other cost-saving measures, such as reining in the cost of insulin and making some vaccines free for Medicare beneficiaries.

All of the 10 drugs on the list were blockbusters. Eight of the 10 were among the bestselling drugs of 2022. The remaining two are insulin formulations from Novo Nordisk: Fiasp and NovoLog.

…

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…

California partners with manufacturer to make affordable generic insulin

[Insulin molecular model image Dr_Microbe/Adobe Stock]

The state of California has established a $50 million collaboration over a decade with the generic drug manufacturer Civica. The goal of the collaboration is to create affordable state-branded generic insulin.

Qualified individuals may obtain a 10-mL vial of generic insulin for $30 or less. California plans to provide a pack containing five prefilled 3 mL pens for $55 or less.

Governor Gavin Newsom hopes California’s emergence as an insulin-maker will lead insulin prices to collapse.

Echoing these efforts, President Biden has made it clear that his administration is dedicated to bringing down health care expenses. In that vein, Biden has urged pharmaceutical giants to rein in insulin prices.

Major insulin makers respond to pressure for lower prices

In recent weeks, Eli Lilly (NYSE:LLY), Novo Nordisk (NYSE:NVO) and Sanofi (Nasdaq:SNY) …

Sanofi joins Lilly and Novo Nordisk in drastic insulin price reductions

[Image courtesy of ayo888 via iStock Photo]

Paris-based Sanofi (Nasdaq:SNY) is the fastest company to reduce insulin prices. The pharmaceutical behemoth said it would cut the list price of Lantus (insulin glargine injection) by 78%. Lantus is its most commonly prescribed insulin in the U.S. Moreover, Sanofi will implement a $35 cap on out-of-pocket expenses for users of the insulin.

Sanofi has also pledged to slash the list price of its short-acting Apidra (insulin glulisine injection) 100 units/mL by a 70%.

The company has a 40% share of the U.S. market.

Lilly and Novo Nordisk have similar initiatives

This follows recent announcements from other companies striving to decrease insulin costs. For example, Eli Lilly (NYSE:LLY) committed to capping out-of-pocket expenses for insulin at $35 monthly. Lilly also said it would drop the price of its non-branded insulin to $25 per vial, resulting in cos…

Roche shares upbeat Phase 3 data for Hemlibra in hemophilia

Facing potential competition from Novo Nordisk’s (NYSE:NVO) investigational blood coagulation factor stimulants Mim8, Roche (SIX:RO, ROG; OTCQX:RHHBY) released positive new data from the Phase 3 HAVEN 6 study focused on the use of Hemlibra (emicizumab) in patients with mild or moderate hemophilia A.

Hemlibra won FDA approval in 2018 for hemophilia A without factor VIII inhibitors.

The drug raked in almost $2.8 billion in sales in 2021.

In the open-label, single-arm HAVEN 6 study, two-thirds of Hemlibra recipients with mild or moderate hemophilia A had no treated bleeds at 55.6 weeks median follow-up.

Basel, Switzerland–based Roche said the drug continued to have a favorable safety profile in patients without factor VIII inhibitors.

The company plans on presenting the data at the International Society on Thrombosis and Haemostasis (ISTH) Annual Congress on July 11, 2022 in London.

Roche intends to ask the European Medicines Agency to …

Semaglutide supply shortfall fuels demand for alternatives

Novo Nordisk (NYSE:NVO) continues to face supply shortages for its Wegovy (semaglutide) pens, which are FDA approved for weight management.

Against that backdrop, a growing number of companies have begun selling compounded versions of the drug.

Drug compounding involves “combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” according to the FDA. The regulatory agency does not approve compounded drugs, nor does it validate their safety, effectiveness or quality.

Novo Nordisk notes on its website that it has “become aware of an increasing trend in compounding pharmacies purporting to have availability of Wegovy or semaglutide.” The company adds that it “does not sell Wegovy (or its active ingredient, semaglutide) for the purposes of compounding with other products.” Novo Nordisk is the only company with FDA approval related to Wegovy, which is offered as a pr…

Novo Nordisk wins FDA approval for higher-dose Ozempic for adults with type 2 diabetes

FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes.

To win the new indication, the Bagsværd, Denmark–based company provided data showing the 2 mg dose led to an average 2.1% blood glucose reduction and weight loss in adults with type 2 diabetes.

In the SUSTAIN Phase 3 clinical trial, a 1 mg dose of Ozempic helped up to 73% of people with type 2 diabetes reach the American Diabetes Association target of <7%.

Ozempic image courtesy of Novo Nordisk

The 2 mg dose could help individuals who need additional glycemic control.

“With its proven safety and efficacy, Ozempic helps deliver on blood glucose control…