Johnson & Johnson ($JNJ) has rolled into the crowded field of new SGLT2 inhibitors with what could become the healthcare giant's first diabetes drug, canagliflozin. The company's Janssen unit has offered up some upbeat evidence from a major Phase III program that the therapy has lowered A1C levels, reduced cardiovascular risks, and provided a weight-loss benefit to boot.
The company has filed this year for approvals of the therapy in the U.S. and Europe, most certainly facing serious regulatory scrutiny as reviewers delve into safety data from the program. Data from the group's big CANVAS study showed higher increases in cholesterol levels and hypoglycemia as well as greater rates of urinary tract infections in patients on the drug than those on placebo.
Canagliflozin is the most advanced diabetes therapy in the pipeline at J&J, which has sought partnerships over the past several years to beef up its R&D of diabetes drugs. Yet the company's partnership strategy has had some setbacks. It dissolved its pact with Diamyd Medical after the failure of a late-stage study of the Swedish company's Type 1 diabetes treatment last year, and its Ortho-McNeil-Janssen Pharmaceuticals unit has ended its collaboration with Isis Pharmaceuticals ($ISIS) on antisense drugs against metabolic diseases such as Type 2 diabetes.
Yet J&J has shown no signs of letting up on the partnership front. Its OMJ unit has a deal with the Hayward, CA-based developer Metabolix. And the healthcare giant inked a deal in July with the German biotech Evotec and Harvard University to license small molecules and biologics that are designed to spur regeneration of insulin-producing beta cells.
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Phase: Under FDA review