Novo Nordisk is about to take on a task that’s so far foiled its peers.
The Danish drugmaker said on Tuesday that it is aiming to expand the global obesity market, both by launching its GLP-1 drug Saxenda in additional countries and by lobbying to get obesity recognized as a chronic disease, a designation that could expand its prescriber base.
And it’s not stopping there. Next up are development plans for its weekly GLP-1 drug semaglutide, up for an FDA approval in diabetes next month. After recording positive phase 2 results for semaglutide in obesity, the company plans to start up a phase 3a clinical trial next year in about 4,500 patients. In addition to that trial, which will run for 68 weeks, Novo also intends to launch a cardiovascular outcomes study with the med in 12,500 obese patients.
Novo certainly doesn’t have to look far to find a cautionary tale when it comes to tackling—or outright creating—the obesity market. It’s got three companies that sought over the past few years to tap a sizable number of patients with their brand-new products.
All three ran into hurdles, and big ones. Sluggish sales forced first-to-market Vivus, which hawks Qsymia, to cut down its sales force—and then cut it down again. Arena chopped its rep army, too, in a shift away from struggling Belviq, which it ultimately handed over to marketing partner Eisai.
And Orexigen saw its own marketing partner, Takeda, walk after disappointing sales and a bungled data disclosure soured the pair’s relationship. Now, the California company is attempting to pursue a sale to make sure it meets its debt obligations, though it’s unclear where the troubled drugmaker will find a buyer.
Novo, though, is no stranger to the obesity space—or the challenges it presents for marketers. It already boasts Saxenda, which shares its active ingredient with diabetes star Victoza, and the company says that drug has been rolled out in more than 20 countries so far. Plus, there’s plenty of overlap between patients suffering from obesity and those suffering from diabetes, an area in which Novo’s specialized for decades.
Looking ahead, the pharma’s hoping to take on surgery with a combination of semaglutide and new biologics. It’s hoping patients can achieve “maybe 25%” weight loss or more, “but we start by setting the bar at 15% or beyond,” SVP of global research Peter Kurtzhals, Ph.D., told investors, as quoted by Reuters.
By Carly Helfand
Source: Fierce Pharma
Novartis will acquire Mariana’s lead candidate MC-339, a radioligand therapy (RLT) designed to target small-cell lung cancer. Last year, Mariana had raised $175m in a Series B round from several funds and pharma giant Eli Lilly.
The company’s aspiration to expand the use of its obesity products to cardiovascular indications has been successful. In March, its blockbuster drug Wegovy was approved by the US Food and Drug Administration (FDA) for reducing the risk of cardiovascular diseases in obese or overweight adults.
Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space.
