Injection pens of Novo Nordisk’s weight-loss drug Wegovy are proven on this picture illustration in Oslo, Norway, Nov. 21, 2023.
Victoria Klesty | Reuters
The dominant weight reduction drugmakers, Novo Nordisk and Eli Lilly, have mentioned provide woes possible will not go away anytime quickly, as the recognition of these medicines continues to soar. However each firms are exhibiting encouraging progress of their efforts to extend provide.
“I feel it will take a couple of years for it to resolve itself,” Cantor Fitzgerald analyst Louise Chen advised CNBC of the availability points. “However I feel each firms will slowly begin to meet the demand available in the market.”
Sufferers have flocked to weight reduction medicine reminiscent of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound because the therapies assist them shed vital kilos over time, regardless of the medicine’ hefty price tags, combined insurance coverage and handful of unpleasant side effects.
Goldman Sachs analysts count on 15 million U.S. adults to be on weight problems medicines by 2030. Some Wall Road analysts undertaking that the burden loss drug market might be worth $100 billion by the tip of the last decade.
As demand spikes, many of the medicine have slipped into intermittent shortages. However there may be restricted information accessible on how vital shortages are or how a lot provide firms have.
“I hear on a regular basis about sufferers going to pharmacies that simply do not have it in inventory for them, particularly because the summer season,” mentioned Dr. Jeff Friedman, the director of bariatric surgical procedure on the College of Florida, who additionally prescribes weight problems medicines.
However each Novo Nordisk and Eli Lilly gave updates on positive supply developments to traders over the past week. They rounded out 2023 with a handful of recent investments in increasing manufacturing capability for his or her weight reduction and diabetes medicine.
These efforts goal to reassure anxious traders that they’ll capitalize on the success of the therapies and to reassure sufferers that they’ll entry the therapies. Novo Nordisk and Eli Lilly look to take care of their edge available in the market as different firms reminiscent of Amgen, Pfizer, AstraZeneca, Roche and smaller weight problems drugmakers race to affix the area.
Novo Nordisk final week mentioned it had more than doubled its provide of lower-dose variations of its weight reduction injection Wegovy in January in contrast with earlier months, which can permit extra individuals to begin taking the drug. Shortages have pressured Novo Nordisk to limit the supply of these decrease “starter” doses within the U.S. since Might.
There may be nonetheless “restricted availability” of 0.25, 0.5, 1 and 1.7-milligram doses of Wegovy, in accordance with a Monday replace on the Meals and Drug Administration’s drug scarcity database. Sufferers usually begin on the 0.25-milligram dose and improve the scale over time to mitigate unwanted side effects reminiscent of nausea.
Novo Nordisk plans to step by step improve Wegovy provide the remainder of the yr, executives mentioned on the corporate’s fourth-quarter earnings name final week.
An Eli Lilly and Firm pharmaceutical manufacturing plant is pictured in Branchburg, New Jersey, March 5, 2021.
Mike Segar | Reuters
Sure doses of Eli Lilly’s diabetes drug Mounjaro, which makes use of the identical lively ingredient as Zepbound, even have restricted availability, in accordance with the FDA. Each therapies are incretin medicine, which mimic intestine hormones to suppress urge for food and regulate blood sugar.
Nonetheless, Eli Lilly achieved its purpose of doubling manufacturing capability for such incretin medicine by the tip of 2023, executives mentioned through the firm’s fourth-quarter earnings name Tuesday. They mentioned the corporate will increase manufacturing with “equal urgency” this yr, with essentially the most vital manufacturing will increase occurring within the second half of the yr.
By that time within the yr, the corporate expects its manufacturing of sellable doses of incretin medicine to be no less than 1.5 occasions greater than it was within the second half of 2023, executives mentioned.
Novo Nordisk and its guardian firm, Novo Holdings, unveiled multibillion-dollar offers that might improve Wegovy provide — simply not but.
Novo Holdings on Monday mentioned it should purchase drug producer Catalent in a $16.5 billion deal. Catalent is the primary provider of fill-finish work, which includes filling and packaging syringes and injection pens, for Wegovy.
Novo Nordisk will then purchase three of Catalent’s manufacturing websites from Novo Holdings for $11 billion. Novo Nordisk mentioned that buy will step by step improve the corporate’s manufacturing capability beginning in 2026.
A normal view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. REUTERS/Yves Herman
Yves Herman | Reuters
In a word Tuesday, TD Cowen analyst Michael Nedelcovych wrote the Catalent offers will possible “enhance manufacturing sooner” than constructing totally new vegetation or including extra manufacturing strains to current websites, strikes Novo Nordisk remains to be pursuing. These efforts are extra “costly and time consuming” than the acquisition, he famous.
Eli Lilly CFO Anat Ashkenazi advised traders throughout an earnings name Tuesday that the corporate has concerns about Novo Holdings’ acquisition, particularly since Eli Lilly contracts Catalent to fabricate a few of its medicines.
However Eli Lilly has mentioned it does not have significant manufacturing coming from Catalent, so the acquisition could have little impact on its enterprise, Cantor Fitzgerald’s Chen mentioned.
Novo Nordisk and Eli Lilly have each poured billions into constructing new manufacturing websites that might enhance provide of their weight reduction and diabetes medicine within the coming years.
On Tuesday, Eli Lilly mentioned a brand new plant in Harmony, North Carolina, will begin manufacturing of incretin medicine as early as the tip of the yr, with merchandise accessible to ship in 2025.
In a word Sunday, Morgan Stanley analysts mentioned they count on that facility and one in North Carolina’s Triangle Park, which began manufacturing final yr, to assist the corporate considerably improve its capability for supplying autoinjector types of Mounjaro, Zepbound and Eli Lilly’s different diabetes drug Trulicity. Autoinjectors are the normal supply gadgets of these medicines.
The corporate additionally will construct a handful of different services over the subsequent few years. Eli Lilly in November mentioned it could spend $2.5 billion to open a producing website for injectable merchandise in Germany, with building starting this yr.
The drugmaker has additionally invested greater than $3 billion to build two new manufacturing services in its house state of Indiana.
In the meantime, Novo Nordisk in November mentioned it could make investments $6 billion to increase its manufacturing websites in Denmark, noting it should end building from the tip of 2025 by means of 2029. The corporate additionally mentioned it could spend around $2.3 billion to construct out one other manufacturing facility in France.
Different types of weight reduction medicine may additionally assist alleviate provide constraints sooner or later.
Eli Lilly has restricted capability to make autoinjectors for Mounjaro and Zepbound. So, the corporate plans to launch Mounjaro in a supply machine referred to as KwikPen in sure nations outdoors of the U.S. The tactic requires extra regulatory approvals. The UK recently approved Mounjaro in KwikPen type.
The drugmaker has mentioned launching KwikPen types of its incretin medicine will increase provide. That is as a result of Eli Lilly for years has used that machine for insulin, so the corporate can faucet into current manufacturing sources to make extra of different incretin medicine.
KwikPen is a single four-dose pen that covers a month’s therapy. Sufferers utilizing autoinjectors undergo 4 completely different pens per 30 days.
Wells Fargo analyst Mohit Bansal wrote in a word final month that if Eli Lilly launches its diabetes and weight reduction medicine in KwikPen type within the U.S., it might be a “supply of provide upside” available in the market for 2025.
However each Eli Lilly and analysts have mentioned that oral types of weight reduction and diabetes medicine, that are usually simpler and cheaper to fabricate, shall be key to assembly demand.
Eli Lilly’s tablet helped obese or overweight sufferers lose as much as 14.7% of their physique weight after 36 weeks in a midstage trial. The end result seemed to be per the burden discount attributable to Novo Nordisk’s oral drug, however over a shorter trial interval.
Nonetheless, Eli Lilly could launch late-stage trial information on the tablet in 2025, so it will not be getting into the market any time quickly.