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Top GLP-1 Legal & Regulatory Concerns for Investors

June 13, 2024
By Miranda Schmalfuhs
Commentary
Video

In this part of his Pharmaceutical Executive video interview, Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses the top legal and regulatory concerns for investors considering when financing companies developing or marketing GLP-1 drugs.

Given the rising popularity of GLP-1 drugs for weight loss, what are the top legal and regulatory concerns that investors should consider when financing companies developing or marketing these drugs?

So, when you're talking about invest from the investor point of view, you have to look at it's a crowded marketplace. And what that typically means when you have a lot of drugs in a class, the route to approval becomes more difficult, the hurdles get a little harder. Because although technically, you have to just show a drug is safe and effective. You don't have to show superiority to existing drugs on the market. In practice, that becomes a question of let's say you have a slightly higher incidence of an adverse effect that could make it more difficult for the product to get approved.

From an investing point of view, we'll look we know there's something like 110 or 20 compounds in development right now, for weight loss in the GLP, one and GLP one plus class, not all of those are going to come to market. So, I think you have to look very carefully as an investor at what's likely to happen. Who's going to get to market how much room is there really. When you have products from very established companies that are quite successful, you know, Lilly and Novo Nordisk have franchises and they will be able to defend them. They can take steps plus just the power of name recognition in the marketplace. People know Zepbound, Mounjaro, Ozempic, Wegovy. And, you know, some of these drugs will break through with the statin class, you had some good examples. There were earlier ones. And then Lipitor came along and blew everyone out of the water. But there were a whole lot of companies at that time developing other statins that were not commercial successes are never saw the light of day.

So, from an investor point of view, looking to invest in these drugs. I think just pick and choose carefully. You might talk a little bit about the legal concern, or you know, is there going to be liability product liability associated with these products? That's always a possibility. You have things like some gas class action lawsuits sits on gastroparesis. On the other hand, you know, when I was at Novo Nordisk, I think clinical trials started around 2002 or 2003. You've now had people on taking these products for 20 something years, and we have not seen a gigantic flood of unexpected adverse reactions. So, I think there will be product liability suits, but I don't think they're going to be a significant problem for companies.

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