The injectable weight-loss remedy Wegovy is offered at New Metropolis Halstead Pharmacy on April 24, 2024 in Chicago, Illinois.
Scott Olson | Getty Pictures
Novo Nordisk and Eli Lilly have lengthy dominated the quickly rising weight reduction drug market, however their duopoly is nearer than ever to going through a menace from a brand new rival.
Amgen is among the many leaders of a pack of drugmakers racing to hitch the market with their very own weight reduction remedies. As the corporate proceeds with the trials wanted to convey its experimental weight problems injection to the market within the coming years, it may see just a few benefits.
Amgen’s drug, MariTide, is taken much less continuously than Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, and will trigger longer-lasting weight reduction than the market leaders’ injections. Amgen, one of many nation’s greatest pharmaceutical corporations, also can produce medicine at scale – an enormous edge over smaller biotech corporations that lack a big manufacturing footprint.
“There are a selection of others making an attempt to interrupt into [the market] each small and huge, however after I step again, I do assume that Amgen has an actual shot at being disruptive and difficult Eli Lilly and Novo,” William Blair & Firm analyst Matt Phipps advised CNBC.
Amgen has seen its shares pop 12% since CEO Bob Bradway on Thursday stated he was “very inspired” by an ongoing mid-stage examine on MariTide. But it surely is not the one firm with an opportunity to upend the market.
Different corporations — like Viking Therapeutics, Altimmune, Construction Therapeutics, AstraZeneca and companions Boehringer Ingelheim and Zealand Pharma — are amongst these which might be making progress on their very own remedies. Novo Nordisk and Eli Lilly are additionally engaged on new weight reduction medicine.
“I do not know if I am prepared to choose one other clear winner but primarily based on the information now we have,” Phipps stated.
The competitors for a slice of the load loss market has solely grown extra fierce in latest months. Nonetheless, regardless of intermittent provide shortages and restricted insurance coverage protection, demand for Wegovy and Zepbound is not anticipated to decelerate anytime quickly. That leaves room for brand new entrants in a phase anticipated to develop to $100 billion by the tip of the last decade.
Whereas Amgen is in a powerful place, it’s going to take years for MariTide to succeed in sufferers. The corporate has not offered an estimated launch date for its weight problems injection. In a analysis be aware printed Thursday, JPMorgan analyst Chris Schott estimated it’s going to hit the market in 2028.
Amgen seems to have a aggressive edge
Amgen is testing out a once-a-month and even much less frequent foundation for its drug, which might be extra handy than the weekly medicines available on the market. A number of drugmakers are creating weekly injections or day by day capsules, however some have not dominated out testing much less frequent dosing for his or her medicine.
MariTide confirmed sustained weight reduction after a single injection or a number of photographs throughout a section one trial, which allowed for much less frequent doses of the drug, in accordance with the examine authors. They added that the corporate’s drug also can stick round within the physique for for much longer than present therapies.
The Amgen brand is displayed outdoors Amgen headquarters in Thousand Oaks, California, on Might 17, 2023.
Mario Tama | Getty Pictures
Phipps stated he is assured that sufferers can take MariTide even much less continuously, resembling as soon as 1 / 4, to keep up the load loss they noticed after beginning the drug. That would make it simpler for Amgen to fabricate sufficient provide – and keep away from a problem that has been plaguing Novo Nordisk and Eli Lilly.
Amgen is already beginning to increase manufacturing capability for MariTide, executives stated throughout an earnings name on Might 2.
Much less frequent doses of MariTide may additionally trigger fewer uncomfortable side effects than different weight reduction remedies, Phipps famous. Many sufferers cease taking current medicine as a result of nausea and vomiting.
MariTide causes a few of those self same uncomfortable side effects, however Phipps stated a month-to-month or quarterly injection of the drug would result in fewer days of feeling sick in contrast with a weekly dose. He added that fewer doses may assist sufferers stick with the remedy and preserve weight reduction.
“Even if you happen to do have some nausea for the day, simply as soon as 1 / 4 versus as soon as every week I believe that is enormous for getting extra sufferers to remain on,” stated Phipps.
Very like Wegovy and Zepbound, Amgen’s remedy prompts a intestine hormone receptor referred to as GLP-1 to assist regulate an individual’s urge for food.
However whereas Zepbound prompts a second appetite-suppressing hormone receptor referred to as GIP, Amgen’s drug blocks it. Wegovy doesn’t goal GIP, which as a receptor may additionally enhance how the physique breaks down sugar and fats.
Whereas Amgen’s progress has excited Wall Avenue and despatched its inventory climbing, different corporations are additionally shifting towards placing a product available on the market. Right here is the place these different medicine stand.
Newer Novo Nordisk, Eli Lilly medicine on the best way
Novo Nordisk and Eli Lilly are creating new medicine for weight reduction and diabetes that might enhance on their present remedies and enter the market sooner than MariTide and different experimental medicines.
They embrace a weekly injection from Novo Nordisk for diabetes and weight problems referred to as CagriSema. That drug combines semaglutide, the energetic ingredient in Wegovy, together with an experimental drug referred to as cagrilintide.
CagriSema helped diabetes sufferers who have been obese or overweight lose 15.6% of their weight after 32 weeks in a mid-stage trial. Novo Nordisk is learning CagriSema in six late-stage medical trials and will launch information from a 68-week examine in overweight sufferers later this yr.
An injection pen of Zepbound, Eli Lilly’s weight reduction drug, is displayed in New York Metropolis, U.S., December 11, 2023.
Brendan McDermid | Reuters
In the meantime, Eli Lilly is learning an experimental drug referred to as retatrutide in a late-stage trial. That remedy helped sufferers lose as much as 24% of their weight after virtually a yr in a mid-stage trial, which set a brand new bar for weight reduction.
Retatrutide mimics three completely different hunger-regulating hormones: GLP-1, GIP and glucagon. That mixture seems to be much more efficient at curbing an individual’s urge for food.
Eli Lilly can also be creating an oral drug referred to as orforglipron, which targets GLP-1. The corporate is slated to launch late-stage trial information on the capsule and retatrutide in 2025.
Boehringer Ingelheim, Zealand Pharma injection
Amongst different potential entrants, Boehringer Ingelheim and Danish biotech agency Zealand Pharma are creating a weekly weight reduction injection. The experimental drug targets GLP-1 to suppress urge for food and glucagon to extend vitality expenditure.
Boehringer Ingelheim in August stated it was shifting the drug, referred to as survodutide, right into a late-stage examine. A mid-stage trial discovered sufferers who’re obese or have weight problems misplaced as much as 19% of their weight after 46 weeks of remedy with the drug.
In February, the businesses additionally posted constructive mid-stage trial information on survodutide in sufferers with a extreme type of liver illness.
Boehringer Ingelheim hopes survodutide will launch as a remedy for weight problems or liver illness in 2027 or 2028, so long as trial information is favorable, in accordance with a Reuters interview.
AstraZeneca and Pfizer capsules
AstraZeneca can also be creating a day by day weight problems capsule, referred to as ECC5004, below a partnership it inked with Chinese language biotech firm Eccogene in November.
AstraZeneca executives have stated the capsule is quickly absorbed and does not keep within the abdomen lengthy, which may cut back uncomfortable side effects relative to current remedies. Executives have additionally stated that sufferers can take the capsule alone or together with its different oral medicine, such because the diabetes drug Farxiga, to deal with weight problems and associated well being points.
However the drug, which targets GLP-1, is years away from coming into the market. The corporate has accomplished a section one trial in sufferers with diabetes and plans to current the information at a medical convention later this yr, executives stated throughout an earnings name in April.
Additionally in an early-stage trial is AstraZeneca’s experimental weight problems drug AZD6234, which targets one other intestine hormone referred to as amylin. The corporate hopes it might mix AZD6234 with its oral GLP-1 to assist sufferers obtain better weight reduction than with current medicine, AstraZeneca CEO Pascal Soriot stated in November.
Outdoors the Macclesfield manufacturing unit of AstraZeneca.
Christopher Furlong | Getty Pictures Information | Getty Pictures
In the meantime, traders are desirous to see new information on Pfizer’s once-daily weight problems capsule across the center of the yr, which can decide the corporate’s destiny within the weight reduction drug market. The corporate scrapped the twice-a-day model of that capsule, danuglipron, in December after sufferers had a troublesome time tolerating it in a trial.
Pfizer may have one other probability to enter the market if it acquires a smaller weight problems drugmaker. However for now, a deal seems unlikely as the corporate works to rebound from the decline of its Covid enterprise final yr.
“Because it pertains to bolt-on acquisitions, within the close to time period you wouldn’t anticipate us to do a lot there,” Pfizer Chief Monetary Officer David Denton stated throughout an earnings name on Might 1.
Smaller biotechs present promise
Past these main pharmaceutical corporations, Viking Therapeutics, Altimmune and Construction Therapeutics have drawn immense consideration to their respective weight reduction drug pipelines. The trio has far fewer assets and fewer manufacturing capability than Amgen or Pfizer, however that might change in the event that they get scooped up by a big drugmaker.
Viking Therapeutics in March launched preliminary information from a mid-stage trial on its experimental injection, which targets GLP-1 and GIP. Those that obtained weekly doses of the remedy misplaced as much as 13.1% of their weight in contrast with sufferers who obtained a placebo after 13 weeks.
Viking will seemingly conduct one other section two trial that might final between six and 9 months, the corporate’s CEO Brian Lian stated throughout an investor name in March. Viking’s remedy seemingly will not attain the market till 2029 or later, Jefferies analyst Akash Tewari wrote in a be aware that very same month.
Additionally in March, Viking stated it plans to begin a section two trial on an oral model of its drug after it confirmed constructive leads to a small examine.
Construction Therapeutics can also be creating an oral GLP-1 for weight problems and diabetes. But it surely missed Wall Avenue’s expectations for weight reduction in a mid-stage trial in December.
The capsule helped overweight sufferers lose roughly 5% of their weight in contrast with those that obtained a placebo after eight weeks.
Construction stated it expects full 12-week outcomes on sufferers with weight problems within the second quarter of this yr. The corporate plans to begin a bigger mid-stage examine within the second half of this yr and a late-stage trial in 2026.
Altimmune is creating a weekly weight problems injection referred to as pemvidutide, which targets GLP-1 and glucagon.
In November, Altimmune launched mid-stage trial information displaying that its drug prompted 15.6% weight reduction on common after 48 weeks. The corporate additionally introduced further information from that examine in March displaying that its injection minimized the lack of muscle mass, a unfavourable facet impact of current weight reduction injections.
Altimmune will meet with the Meals and Drug Administration within the second half of the yr to chart a path ahead for the injection.
Correction: This text has been up to date to mirror the right spelling of Bob Bradway’s title.