Amgen could threaten Novo Nordisk, Eli Lilly weight loss drug dominance

Novo Nordisk and Eli Lilly have lengthy dominated the quickly rising weight reduction drug market, however their duopoly is nearer than ever to dealing with 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 therapies. As the corporate proceeds with the trials wanted to deliver its experimental weight problems injection to the market within the coming years, it might see just a few benefits.

Amgen’s drug, MariTide, is taken much less ceaselessly 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, may also produce medication at scale – an enormous edge over smaller biotech corporations that lack a big manufacturing footprint. 

„There are a selection of others attempting to interrupt into [the market] each small and huge, however once I step again, I do suppose that Amgen has an actual shot at being disruptive and difficult Eli Lilly and Novo,” William Blair & Firm analyst Matt Phipps instructed CNBC. 

Amgen has seen its shares pop 12% since CEO Bob Bradway on Thursday mentioned he was „very inspired” by an ongoing mid-stage examine on MariTide. Nevertheless it 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 therapies. Novo Nordisk and Eli Lilly are additionally engaged on new weight reduction medication.

„I do not know if I am prepared to choose one other clear winner but based mostly on the information now we have,” Phipps mentioned.

The competitors for a slice of the burden 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 spanking 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’ll take years for MariTide to succeed in sufferers. The corporate has not supplied an estimated launch date for its weight problems injection. In a analysis notice printed Thursday, JPMorgan analyst Chris Schott estimated it’ll hit the market in 2028. 

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 drugs, however some have not dominated out testing much less frequent dosing for his or her medication. 

MariTide confirmed sustained weight reduction after a single injection or a number of pictures throughout a part one trial, which allowed for much less frequent doses of the drug, in keeping with the examine authors. They added that the corporate’s drug may also stick round within the physique for for much longer than present therapies.

Phipps mentioned he is assured that sufferers can take MariTide even much less ceaselessly, comparable to as soon as 1 / 4, to take care of the burden loss they noticed after beginning the drug. That might 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 develop manufacturing capability for MariTide, executives mentioned throughout an earnings name on Might 2.

Much less frequent doses of MariTide might also trigger fewer unwanted effects than different weight reduction therapies, Phipps famous. Many sufferers cease taking current medication on account of nausea and vomiting.

MariTide causes a few of those self same unwanted effects, however Phipps mentioned 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 might assist sufferers persist with the therapy and preserve weight reduction.

„Even in the event you do have some nausea for the day, simply as soon as 1 / 4 versus as soon as every week I believe that is big for getting extra sufferers to remain on,” mentioned Phipps. 

Very similar to Wegovy and Zepbound, Amgen’s therapy 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 might also 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 medication stand.

Novo Nordisk and Eli Lilly are creating new medication for weight reduction and diabetes that might enhance on their present therapies and enter the market sooner than MariTide and different experimental medicines.

They embody a weekly injection from Novo Nordisk for diabetes and weight problems referred to as CagriSema. That drug combines semaglutide, the lively ingredient in Wegovy, together with an experimental drug referred to as cagrilintide. 

CagriSema helped diabetes sufferers who have been chubby or overweight lose 15.6% of their weight after 32 weeks in a mid-stage trial. Novo Nordisk is finding out CagriSema in six late-stage scientific trials and will launch information from a 68-week examine in overweight sufferers later this 12 months.

In the meantime, Eli Lilly is finding out an experimental drug referred to as retatrutide in a late-stage trial. That therapy helped sufferers lose as much as 24% of their weight after nearly a 12 months in a mid-stage trial, which set a brand new bar for weight reduction.

Retatrutide mimics three totally 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 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 tablet and retatrutide in 2025. 

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 power expenditure. 

Boehringer Ingelheim in August mentioned it was shifting the drug, referred to as survodutide, right into a late-stage examine. A mid-stage trial discovered sufferers who’re chubby or have weight problems misplaced as much as 19% of their weight after 46 weeks of therapy 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 therapy for weight problems or liver illness in 2027 or 2028, so long as trial information is favorable, in keeping with a Reuters interview.

AstraZeneca can be creating a day by day weight problems tablet, referred to as ECC5004, underneath a partnership it inked with Chinese language biotech firm Eccogene in November. 

AstraZeneca executives have mentioned the tablet is quickly absorbed and would not keep within the abdomen lengthy, which might cut back unwanted effects relative to current therapies. Executives have additionally mentioned that sufferers can take the tablet alone or together with its different oral medication, 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 getting into the market. The corporate has accomplished a part one trial in sufferers with diabetes and plans to current the information at a medical convention later this 12 months, executives mentioned 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 higher weight reduction than with current medication, AstraZeneca CEO Pascal Soriot mentioned in November.

In the meantime, traders are desirous to see new information on Pfizer’s once-daily weight problems tablet across the center of the 12 months, which can decide the corporate’s destiny within the weight reduction drug market. The corporate scrapped the twice-a-day model of that tablet, danuglipron, in December after sufferers had a tough time tolerating it in a trial. 

Pfizer might have one other likelihood 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 12 months.

„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 mentioned throughout an earnings name on Might 1.

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 therapy misplaced as much as 13.1% of their weight in contrast with sufferers who obtained a placebo after 13 weeks. 

Viking will possible conduct one other part two trial that might final between six and 9 months, the corporate’s CEO Brian Lian mentioned throughout an investor name in March. Viking’s therapy possible will not attain the market till 2029 or later, Jefferies analyst Akash Tewari wrote in a notice that very same month.

Additionally in March, Viking mentioned it plans to start out a part two trial on an oral model of its drug after it confirmed constructive ends in a small examine.

Construction Therapeutics can be creating an oral GLP-1 for weight problems and diabetes. Nevertheless it missed Wall Avenue’s expectations for weight reduction in a mid-stage trial in December.

The tablet helped overweight sufferers lose roughly 5% of their weight in contrast with those that obtained a placebo after eight weeks.

Construction mentioned it expects full 12-week outcomes on sufferers with weight problems within the second quarter of this 12 months. The corporate plans to start out a bigger mid-stage examine within the second half of this 12 months 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 exhibiting that its drug precipitated 15.6% weight reduction on common after 48 weeks. The corporate additionally introduced extra information from that examine in March exhibiting that its injection minimized the lack of muscle mass, a damaging aspect impact of current weight reduction injections. 

Altimmune will meet with the Meals and Drug Administration within the second half of the 12 months to chart a path ahead for the injection.

Correction: This text has been up to date to replicate the right spelling of Bob Bradway’s title.