Glaxo Shifts Rx Resveratrol Focus But Nutritional Interest Still Strong
This article was originally published in The Tan Sheet
Executive Summary
GlaxoSmithKline's decision to abandon its pharmaceutical research program on resveratrol leaves the red wine extract exclusively to the nutritionals industry.
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GlaxoSmithKline's decision to abandon its pharmaceutical research program on resveratrol leaves the red wine extract exclusively to the nutritionals industry. Dietary supplement firms marketing resveratrol-containing products also face the challenge of clearly demonstrating the substance's benefits. GSK subsidiary Sirtris Pharmaceuticals no longer is studying its SRT501 formulation of resveratrol, which some believe offers anti-aging benefits by activating a protein called SIRT1. Instead, "we are focusing our efforts now on more selective SIRT1 activator compounds that have no chemical relationship to SRT501 and more favorable drug-like properties," said Melinda Stubbee, director of GSK's research & development communications. Stubbee said in an e-mail that Sirtris is conducting phase II trials on the effects of SRT2104 in patients with type 2 diabetes and patients with psoriasis. She added that a phase I safety trial on SRT2379 also is complete. By abandoning pure resveratrol as the basis for a drug candidate – as The New York Times reported this month – Glaxo further separates itself from the world of dietary supplements and foods containing resveratrol. In 2010, the firm disciplined a pair of Sirtris executives who were moonlighting on the board of the Healthy Lifespan Institute, a nonprofit selling resveratrol supplements online ("Glaxo finds execs selling resveratrol supplements," "The Tan Sheet" Aug. 16, 2010, In Brief). Product Proliferation Resveratrol occupies a narrow but growing niche of the food and supplement industries. According to market research firm SPINS Inc., U.S. sales of products containing the antioxidant ingredient grew 22% to $8.4 million in the 52 weeks ended Dec. 25. SPINS data come from natural supermarkets, excluding Whole Foods, and conventional food, drug and mass merchandise stores, excluding Walmart. In 2010, Enzymatic Therapy, Twinlab, Lifeway Foods and Schiff Nutrition introduced supplements or foods featuring resveratrol. DSM Nutritional Products markets its resVida ingredient for supplements and fortified foods, including ResVez Inc.'s Winetime chocolate nutrition bar ( (Also see "New Products In Brief" - Pink Sheet, 21 Dec, 2009.), New Products In Brief). DSM has a patented manufacturing process for resVida and has self-affirmed that its resveratrol is generally recognized as safe.
Additionally, the ingredient supplier has filed with FDA structure/function claims it makes for resveratrol, including that it "may protect the cardiovascular system," "may maintain neurocognitive function" and "may improve balance, sensory-motor coordination and endurance." Reto Rieder, a senior marketing manager with DSM, said resVida is differentiated by its safety profile and ongoing human clinical study program. However, some other sources of resveratrol may base their marketing on unsupported claims. "Huge media interest" in the ingredient – including from CBS' "60 Minutes," Oprah Winfrey and Barbara Walters – "unfortunately also leads to proliferation of questionable products by questionable companies," Rieder said in an e-mail. The National Advertising Division of the Council of Better Business Bureaus recently announced Collagen Nutraceuticals appropriately discontinued Alzheimer's disease and cancer risk-reduction claims for its Reversitall supplement with resveratrol ( (Also see "National Advertising Division In Brief" - Pink Sheet, 24 Jan, 2011.), National Advertising Division In Brief). Grape Expectations Glaxo's exit from the resveratrol business reportedly was linked to the extract's unpredictability and instability, aspects hardly conducive to pharmaceutical formulations. Still, researchers and supplement industry stakeholders hope that the antioxidant ingredient extracted from grape skins will demonstrate cardiovascular, anti-inflammatory and anti-cancer benefits in humans. DSM notes that the first human clinical study using resVida showed a 30 mg dose was associated with "a significant increase of flow mediated dilation," an indicator of cardiovascular health. Results from subsequent human studies are pending. In December 2010, Boston University completed a trial testing resVida's effects on endothelial function – preventing blood clot formation – in patients with diabetes mellitus. Another clinical wrapped up data collection in December and will compare resVida to a calorie-restricted diet by observing cholesterol levels, insulin function and other markers of metabolic and cardiovascular health. A forthcoming publication on "Resveratrol and Health" from the Annals of the New York Academy of Sciences notes that most resveratrol benefits observed thus far are limited to mouse and rat studies, and "the effects of resveratrol on the lifespan of many model organisms remain controversial." By Dan Schiff |