Boston’s struggle with obesity
With an effective obesity drug already available and more in the pipeline, what hope do devices have?
There are currently only six medical technologies approved by the FDA to help obese people lose weight, and, having bid $615m for Apollo Endosurgery last week, Boston Scientific will soon own two of them. However, last year saw the market entry of a powerful weight loss drug, Novo Nordisk’s Wegovy, and approval of another, Lilly’s Mounjaro, is in the offing.
Then there are the promising, though early, data on Amgen’s AMG 133, toplined last week and presented more fully on Saturday. Perhaps one day this too could become a competitor in this space, but Wegovy and Mounjaro are the threats Boston must face in the immediate term.
The products are intended for different populations, with devices being reserved for patients with more severe, or drug-resistant, disease – so the pharmaceuticals will seize a much larger market than the devices. But Boston has at least bought probably the most effective of these devices, and the acquisition of these obesity products could still turn out to be a successful, if niche, play.
The first device specifically approved for weight loss in obese patients was the Lap-Band gastric band. This has changed hands repeatedly over the years, having been developed by Inamed’s Bioenterics subsidiary, which saw it approved in 2001. Inamed was bought by Allergan for $3.1bn in 2006, and Apollo bought Allergan’s obesity portfolio, including Lap-Band, in 2014 for $90m. Apollo then sold its surgical products, again including Lap-Band, four years later to Reshape Medical for just $10m up front.
Apollo is one of four companies offering a gastric balloon. These are either placed in the stomach endoscopically or swallowed, and are then inflated either with nitrogen gas or saline. These can only be used temporarily, usually for around six months.
But Apollo's newest device, used to create a “gastric sleeve” in a procedure in which the stomach is folded and stitched to reduce both its volume and the speed of its emptying, seems to be more effective than all the other devices. Apollo ESG allowed sham-adjusted total weight loss of 13.1% in its pivotal trial, and excess weight loss of 46.8% – better than Lap-Band.
But Apollo ESG was only approved a few months ago, and as yet has no reimbursement. Stifel analysts say it could bring in around $64m a year from out-of-pocket payments.
The pharmaceutical approach
This is peanuts compared with the forecast sales of the new wave of obesity drugs. Wegovy, which allowed slightly greater weight loss than Apollo ESG if their respective pivotal trials are compared, is forecast to sell $867m next year, rising to $7.8bn in 2028, Evaluate Pharma’s sellside consensus shows. And that forecast might be higher were it not for the trouble Novo is having meeting the vast demand for the GLP-1 agonist.
Mounjaro, Lilly’s GIP/GLP-1 co-agonist that is not yet approved for obesity, had even more spectacular results, at least with the higher two doses used in its pivotal obesity trial. With safety, too, looking better than Wegovy’s, expectations for Mounjaro are colossal. It is forecast to sell $5.3bn in obesity in 2028, according to Evaluate Pharma consensus.
There are also high hopes for Amgen’s AMG 133, which has a different mechanism again, being a GLP-1 agonist but a GIP receptor inhibitor. It will be some years before robust, late-stage data emerge on this project, however.
Devices are second fiddle to drug therapy already, and will fall further down the pecking order should Mounjaro reach patients. But demand for obesity therapies is so great that medical technologies will find a market, albeit a rather smaller one than the pharmaceutical interventions. It is now up to Boston to make the most of what opportunity it can find.
|Obesity in the US: devices vs drugs|
|Company||Device/drug||FDA approval date||Patient population||Weight loss in pivotal trial|
|Reshape Medical||Lap-Band (gastric band)||Jun 5, 2001||BMI of 40+ or 35-40 with comorbidities||Mean excess weight loss of 36%*|
|Apollo Endosurgery||Orbera (balloon)||Aug 5, 2015||BMI of 30-40||IB-005 trial: sham-adj total weight loss of 6.9%|
|Reshape Medical||Obalon (balloon)||Sep 8, 2016||BMI of 30-40||Smart trial: sham-adj total weight loss of 3.2%|
|Baronova||TransPyloric Shuttle (balloon)||Apr 16, 2019||BMI of 40+ or 35-40 with comorbidities||Endobesity II trial: sham-adj total weight loss of 6.7%|
|Spatz Medical||Spatz3 (balloon)||Oct 15, 2021||BMI of 40+ or 35-40 with comorbidities||Sabo trial: sham-adj total weight loss of 11.7%|
|Apollo Endosurgery||Apollo ESG
(creates gastric sleeve)
|Jul 12, 2022||BMI of 30-50||Merit trial: sham-adj total weight loss of 13.1%|
|The new obesity drugs|
|Novo Nordisk||Wegovy (GLP-1 agonist)||Jun 4, 2021||BMI of 30+ or 27-30 with comorbidities||Step-1 and -3 trials: pbo-adj total weight loss of 12.4% & 10.3%|
|Lilly||Mounjaro (GLP-1/GIP agonist)||Filing expected 2022||?||Surmount-1 trial: pbo-adj total weight loss of 17.8%|
|Selected old obesity drugs|
|Novo Nordisk||Saxenda (GLP-1 agonist)||Dec 23, 2014||BMI of 30+ or 27-30 with comorbidities||Scale trial: pbo-adj total weight loss of 5.4%|
|Vivus||Qsymia (adrenoceptor agonist )||Jul 17, 2012||BMI of 30+ or 27-30 with comorbidities||Conquer and Equip trials: Pbo-adj total weight loss of 8.6-9.4%|
|*No sham group, and no total weight loss figures available. For drugs, only data for the highest dose approved, or used in the pivotal trial, is included.|