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dual-track strategy. One track called for advancing Lovidia as a nutritional supplement (with ingredients generally recognized as safe) that would help people lose weight by increasing the production of natural hormones in the gut that increase the feeling of satiety. After spinning NaZura out in late 2013, the team intended to begin online sales of Lovidia capsules in mid-2014, with retail distribution planned for this year.
The spinout had the added benefit of narrowing the business focus at Elcelyx, which would make a buyout of Elcelyx more straightforward. Of course, selling NaZura simplified things even more.
The other track at Elcelyx involved the development of a “delayed-release” version of metformin—intended for use by patients with type 2 diabetes who literally cannot stomach existing formulations of metformin.
According to Baron, about 40 percent of the patients with type 2 diabetes cannot take metformin, either because of adverse side effects that include severe nausea, vomiting, and diarrhea, or because the patients’ impaired kidney function leads to a condition known as metformin-associated lactic acidosis.
The Elcelyx CEO estimates that some 8 million Americans have one problem or the other. The 3.6 million who have impaired renal function are also subject to an FDA “contraindication” notice, which usually precludes doctors from prescribing metformin. Baron said much of the company’s talks with FDA regulators last year was focused on the type of studies and data that would be needed to ease the regulatory restriction.
The problem, Baron explained, is that existing formulations of metformin dissolve in the stomach, where the drug is absorbed into the bloodstream and acts systemically. In contrast, the delayed-release formulation of metformin passes through the stomach, and is designed to stay in the intestines, where the drug mostly acts locally, Baron said.
As a result, Baron said the dosage required for delayed-release metformin is about half the dose of conventional metformin—and the amount of metformin in the bloodstream is reduced by 75 percent.
“It’s an old drug that’s been completely reinvented to meet an unmet need,” Baron said. And if everything proceeds according to plan, he said, the new formulation of metformin could be approved for use in the United States in less than five years.
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