Amgen, newer rivals may threaten Novo Nordisk and Eli Lilly's weight reduction drug dominance 

Novo Nordisk and Eli Lilly have lengthy dominated the quickly rising weight loss 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 affix the market with their very own weight reduction therapies. As the corporate proceeds with the trials wanted to carry its experimental weight problems injection to the market within the coming years, it may see a few advantages.

Amgen’s drug, MariTide, is taken much less often 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 attempting to interrupt into [the market] each small and enormous, however once 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 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 research on MariTide. But it surely is not the one firm with an opportunity to upend the market.

Different corporations — like Viking Therapeutics, Altimmune, Structure 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 loss drugs.

“I do not know if I am prepared to select one other clear winner but primarily based on the info we’ve got,” Phipps mentioned.

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 spanking new entrants in a phase anticipated to develop to $100 billion by the top of the last decade.

Whereas Amgen is in a robust place, it’ll take years for MariTide to achieve sufferers. The corporate has not offered an estimated launch date for its weight problems injection. In a analysis observe printed Thursday, JPMorgan analyst Chris Schott estimated it’ll hit the market in 2028. 

MariTide confirmed sustained weight loss after a single injection or a number of photographs throughout a part one trial, which allowed for much less frequent doses of the drug, in line with the research authors. They added that the corporate’s drug also can 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 often, akin to as soon as 1 / 4, to keep up the load loss they noticed after beginning the drug. That might make it simpler for Amgen to fabricate sufficient provide – and keep away from a difficulty that has been plaguing Novo Nordisk and Eli Lilly.

Amgen is already beginning to increase manufacturing capability for MariTide, executives mentioned throughout an earnings name on Might 2.

Much less frequent doses of MariTide may trigger fewer unintended effects than different weight reduction therapies, Phipps famous. Many sufferers cease taking present medicine as a consequence of nausea and vomiting.

MariTide causes a few of those self same unintended 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 may assist sufferers follow the remedy and keep weight reduction.

“Even should you do have some nausea for the day, simply as soon as 1 / 4 versus as soon as per week I feel that is large for getting extra sufferers to remain on,” mentioned Phipps. 

Very similar to 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 enhance how the physique breaks down sugar and fats.

Whereas Amgen’s progress has excited Wall Road 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.

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 clinical trials and will launch knowledge from a 68-week study in overweight sufferers later this yr.

In the meantime, Eli Lilly is finding out 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 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 growing an oral drug referred to as orforglipron, which targets GLP-1. The corporate is slated to launch late-stage trial knowledge on the capsule and retatrutide in 2025. 

Amongst different potential entrants, Boehringer Ingelheim and Danish biotech agency Zealand Pharma are growing a weekly weight loss injection. The experimental drug targets GLP-1 to suppress urge for food and glucagon to extend vitality expenditure. 

Boehringer Ingelheim in August mentioned it was shifting the drug, referred to as survodutide, right into a late-stage study. 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 remedy with the drug.

In February, the businesses additionally posted constructive mid-stage trial knowledge 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 knowledge is favorable, in line with a Reuters interview.

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

AstraZeneca executives have mentioned the capsule is rapidly absorbed and does not keep within the abdomen lengthy, which may scale back unintended effects relative to present therapies. Executives have additionally mentioned 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 part one trial in sufferers with diabetes and plans to current the info at a medical convention later this yr, 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 can combine AZD6234 with its oral GLP-1 to assist sufferers obtain higher weight reduction than with present medicine, AstraZeneca CEO Pascal Soriot mentioned in November.

In the meantime, traders are wanting to see new knowledge on Pfizer’s once-daily weight problems capsule across the center of the yr, which is able to 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 tough time tolerating it in a trial. 

Pfizer may 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 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 mentioned throughout an earnings name on Might 1.

Viking Therapeutics in March launched initial data 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 part two trial that would final between six and 9 months, the corporate’s CEO Brian Lian mentioned 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 observe that very same month.

Additionally in March, Viking mentioned it plans to begin a part two trial on an oral model of its drug after it confirmed positive results in a small research.

Construction Therapeutics can be growing an oral GLP-1 for weight problems and diabetes. But it surely missed Wall Road’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 mentioned 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 research within the second half of this yr and a late-stage trial in 2026. 

Altimmune is growing a weekly weight problems injection referred to as pemvidutide, which targets GLP-1 and glucagon.

In November, Altimmune launched mid-stage trial knowledge exhibiting that its drug prompted 15.6% weight reduction on common after 48 weeks. The corporate additionally introduced further knowledge from that research in March exhibiting that its injection minimized the loss of muscle mass, a adverse facet impact of present 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 proper spelling of Bob Bradway’s title.