Novo Nordisk, Eli Lilly are tackling supply issues

The insatiable demand for weight reduction drugs is trouncing supply, leaving many patients struggling to search out the injectable treatments. 

The dominant weight reduction drugmakers, Novo Nordisk and Eli Lilly, have said supply woes likely won’t go away anytime soon, as the recognition of those medicines continues to soar. But each firms are showing encouraging progress of their efforts to extend supply. 

“I feel it should take just a few years for it to resolve itself,” Cantor Fitzgerald analyst Louise Chen told CNBC of the availability issues. “But I feel each firms will slowly start to fulfill the demand out there.” 

Patients have flocked to weight reduction drugs comparable to Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound because the treatments help them shed significant kilos over time, despite the drugs’ hefty price tags, mixed insurance coverage and handful of unpleasant unwanted side effects.

Goldman Sachs analysts expect 15 million U.S. adults to be on obesity medications by 2030. Some Wall Street analysts project that the burden loss drug market may very well be price $100 billion by the tip of the last decade.

As demand spikes, many of the drugs have slipped into intermittent shortages. But there is restricted data available on how significant shortages are or how much supply firms have.

“I hear on a regular basis about patients going to pharmacies that just haven’t got it in stock for them, especially because the summer,” said Dr. Jeff Friedman, the director of bariatric surgery on the University of Florida, who also prescribes obesity medications.

But each Novo Nordisk and Eli Lilly gave updates on positive supply developments to investors during the last week. They rounded out 2023 with a handful of recent investments in expanding production capability for his or her weight reduction and diabetes drugs.

Those efforts aim to reassure anxious investors that they’ll capitalize on the success of the treatments and to reassure patients that they’ll access the treatments. Novo Nordisk and Eli Lilly look to keep up their edge out there as other firms comparable to Amgen, Pfizer, AstraZeneca, Roche and smaller obesity drugmakers race to hitch the space. 

Novo Nordisk last week said it had greater than doubled its supply of lower-dose versions of its weight reduction injection Wegovy in January compared with previous months, which is able to allow more people to begin taking the drug. Shortages have forced Novo Nordisk to limit the supply of those lower “starter” doses within the U.S. since May. 

There remains to be “limited availability” of 0.25, 0.5, 1 and 1.7-milligram doses of Wegovy, in response to a Monday update on the Food and Drug Administration’s drug shortage database. Patients typically start on the 0.25-milligram dose and increase the dimensions over time to mitigate unwanted side effects comparable to nausea. 

Novo Nordisk plans to steadily increase Wegovy supply the remainder of the yr, executives said on the corporate’s fourth-quarter earnings call last week.

Certain doses of Eli Lilly’s diabetes drug Mounjaro, which uses the identical energetic ingredient as Zepbound, even have limited availability, in response to the FDA. Each treatments are incretin drugs, which mimic gut hormones to suppress appetite and regulate blood sugar.

Still, Eli Lilly achieved its goal of doubling production capability for such incretin drugs by the tip of 2023, executives said in the course of the company’s fourth-quarter earnings call Tuesday. They said the corporate will expand production with “equal urgency” this yr, with essentially the most significant production increases occurring within the second half of the yr. 

By that time within the yr, the corporate expects its production of sellable doses of incretin drugs to be no less than 1.5 times higher than it was within the second half of 2023, executives said.

Novo Nordisk and its parent company, Novo Holdings, unveiled multibillion-dollar deals that might increase Wegovy supply — just not yet.

Novo Holdings on Monday said it can acquire drug manufacturer Catalent in a $16.5 billion deal. Catalent is the foremost supplier of fill-finish work, which involves filling and packaging syringes and injection pens, for Wegovy. 

Eli Lilly CFO Anat Ashkenazi told investors during an earnings call Tuesday that the corporate has concerns about Novo Holdings’ acquisition, especially since Eli Lilly contracts Catalent to fabricate a few of its medications. 

But Eli Lilly has said it doesn’t have meaningful production coming from Catalent, so the acquisition can have little effect on its business, Cantor Fitzgerald’s Chen said.

The corporate also will construct a handful of other facilities over the subsequent few years. Eli Lilly in November said it could spend $2.5 billion to open a producing site for injectable products in Germany, with construction starting this yr.

The drugmaker has also invested greater than $3 billion to construct two latest production facilities in its home state of Indiana. 

Meanwhile, Novo Nordisk in November said it could invest $6 billion to expand its manufacturing sites in Denmark, noting it can finish construction from the tip of 2025 through 2029. The corporate also said it could spend around $2.3 billion to construct out one other production facility in France. 

Eli Lilly has limited capability to make autoinjectors for Mounjaro and Zepbound. So, the corporate plans to launch Mounjaro in a delivery device called KwikPen in certain countries outside of the U.S. The strategy requires additional regulatory approvals. The UK recently approved Mounjaro in KwikPen form. 

The drugmaker has said launching KwikPen types of its incretin drugs will expand supply. That is because Eli Lilly for years has used that device for insulin, so the corporate can tap into existing manufacturing resources to make more of other incretin drugs. 

KwikPen is a single four-dose pen that covers a month’s treatment. Patients using autoinjectors undergo 4 different pens per thirty days.

Wells Fargo analyst Mohit Bansal wrote in a note last month that if Eli Lilly launches its diabetes and weight reduction drugs in KwikPen form within the U.S., it may very well be a “source of supply upside” out there for 2025.

But each Eli Lilly and analysts have said that oral types of weight reduction and diabetes drugs, that are typically easier and cheaper to fabricate, might be key to meeting demand.

Eli Lilly is developing an oral drug called orforglipron, which can have an edge over experimental weight reduction pills from Novo Nordisk and Pfizer. 

Eli Lilly’s pill helped obese or obese patients lose as much as 14.7% of their body weight after 36 weeks in a midstage trial. The result seemed to be consistent with the burden reduction brought on by Novo Nordisk’s oral drug, but over a shorter trial period. 

Still, Eli Lilly may release late-stage trial data on the pill in 2025, so it won’t be entering the market any time soon.