Allurion launches compounded GLP-1 program as FDA aims to end access

Yahoo Finance
2024-11-26

Allurion (ALUR) launched a new program to provide patients access to compounded weight-loss drugs Monday after months of pitching its own weight-loss solution — an ingestible balloon — as an alternative for patients who may not want to use the popular injectable GLP-1 drugs. 

Allurion CEO Shantanu Gaur told Yahoo Finance that, like others, the company continues to see a spillover effect from the unprecedented interest in GLP-1 drugs like Novo Nordisk's (NVO) Wegovy and Eli Lilly's (LLY) Zepbound. It's why the company is now offering copycat products at a fraction of the cost.

Allurion's new program uses artificial intelligence guidance to help patients adhere to a well-rounded diet and exercise routine in addition to using GLP-1s. The AI coach launched in May, and access to compounded semaglutide, the key ingredient in Novo's Wegovy drug, begins Monday. 

Gaur said the company also has plans to launch tirzepatide, the key ingredient in Lilly's Zepbound. The FDA recently declared an end to the shortage of tirzepatide, which put compounding manufacturers in a 60-day window to end production. The FDA allows copycat drugs to be produced if the branded makers are unable to meet demand — which Gaur and others say is still the case despite the FDA's declaration.

Allurion's gastric balloon

Some compounders filed suit against the FDA to allow continued production. The FDA recently delayed its decision on the matter until Dec. 19, keeping access to compounded versions intact for now. Semaglutide, meanwhile, is separately under review by the FDA for its place on the agency's drug shortage list. Novo Nordisk notified the agency it was able to meet demand, and the FDA will make its decision after it reviews the company's data.

Allurion's decision to join in the GLP-1 space at this juncture speaks to the ongoing demand for the drugs, despite its an ingestable balloon having similar results to the weight-loss drugs. The device helps regulate a person's food intake, resulting in patients losing up to 15% of their body weight after four months on average. 

The balloon is not yet available in the US but is approved in other countries. Patients who have tried and failed to lose weight with the GLP-1s or are trying to look for alternatives have become interested in the balloon, Gaur said.

"Last year, 25% of our balloon patients had previously tried a GLP-1," he said. "This year, that number has grown to 33%." 

Still, the lack of US approval and the ongoing demand for GLP-1s has pressured the company's stock — which is down 96% to less than $0.50 per share since it de-SPACed and went public in April 2021. The company has been notified it meets the requirements for delisting from the New York Stock Exchange, but Gaur said the company is working on building back.

When asked if the decision to join in on the GLP-1 frenzy, was an indication of that, Gaur said, "We have a plan to address the delisting. The news may help, but the plan is independent of it."

The company's stock fell on the news of the announcement Monday, trading down nearly 3% to $0.41 per share.

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Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee on most social media platforms @AnjKhem.

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