Quercegen Pharmaceuticals LLC Obtains FDA GRAS Notified Status for Its QU995™ Quercetin with Purity Greater Than 99.5%

Launching patented health formula in Q-Force™ performance soft chews

SUDBURY, Mass.--()--Quercegen Pharmaceuticals LLC, producer of plant-based nutrients for the pharmaceutical and nutraceutical industries and creator of Q-Force™, was notified that its QU995™, The World’s Purest Quercetin™, received GRAS (“Generally Recognized As Safe”) notified status on November 22, 2010 under U.S. Food and Drug Administration GRAS Inventory Number GRN 341. A copy of the comprehensive safety dossier submitted to the FDA by Quercegen can be found on the Agency’s website. www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm235935.htm

Quercetin is a natural polyphenolic antioxidant flavonoid found in many plants. It plays an important role in the inhibition of enzymes involved in free radical production and can potentially be used for the prevention and alleviation of conditions that cause oxidative stress. Quercetin is being studied for a wide range of health and performance benefits across the globe and is now serving as a functional ingredient to foods, beverages and dietary supplements.

“Achieving GRAS Status represents a major milestone for Quercegen Pharmaceuticals,” said Quercegen CEO Gordon Brooks. “After many years of hard work and significant investment we are delighted to be able to offer products with our highly purified, food-grade Quercetin at levels of up to 500 milligrams per serving. We are grateful to our relentless science team as well as our commercial partners who helped us to achieve this.”

Evolving from self-affirmed GRAS to gaining GRAS notified status from the FDA expands opportunities for QU995™ Quercetin to no longer be limited to dietary supplements, but can be used by food manufacturers worldwide. To be accepted in the mass food industry, a new food ingredient needs to be shown to be Generally Regarded As Safe (GRAS). In addition, the FDA will not consider an ingredient for a health claim (substantiated or qualified) if the ingredient has not been demonstrated to be GRAS.

After years of research and work in collaboration with Merck Natural Products, commercial partners and various United States government agencies, Quercegen is introducing its first branded product, Q-Force™ (www.qforce.com) to the U.S. and European markets. Together with DARPA (the U.S. Defense Advanced Research Projects Agency) and Nutravail Technologies, the Company developed Q-Force™ soft chews, which have been sold mainly to military personnel since 2007 and are now scheduled for a broader consumer rollout in 2011. Q-Force™ will be promoted towards active consumers seeking enhanced performance and overall health.

“DARPA researchers have identified a very safe, natural antioxidant – called Quercetin – and developed it into a new form that is now available to the military and the general public. Among Quercetin’s many potential benefits is illness prevention. In a randomized, placebo-controlled study, Quercetin helped prevent viral illnesses, like colds and flu, after physical exertion. Following a strenuous 3-day exercise routine, 50 percent of the control group became ill with colds and flu, whereas only five percent of the Quercetin supplemented group did. This important immune protective effect will help keep our warfighters healthy during training and deployment. Quercetin has been commercialized as RealFX Q-Plus™* soft chews, which are now available through several commercial vendors, as well as to all military personnel at a 50 percent discount.”
--Dr. Tony Tether, Director, Defense Advanced Research Projects Agency
Testimony Submitted to the Subcommittee on Terrorism, Unconventional Threats and Capabilities, House Armed Services Committee, United States House of Representatives, March 13, 2008.
(*RealFX Q-Plus™ was rebranded as Q-Force™ in 2010)

Quercetin has been the subject of over 7,000 research studies and the Company’s QU995™ has been used in U.S. Department of Defense funded clinical trials in animals and humans since 2006.

“Quercetin exerts strong anti-oxidative, anti-inflammatory, anti-pathogenic, and immune regulatory effects in vitro and in animal-based studies. Epidemiological data indicates reduced rates of cardiovascular disease and various types of cancer in groups self-selecting diets high in Quercetin. Several recent supplementation studies in athletes have focused on Quercetin’s potential influences as a countermeasure to post-exercise inflammation, oxidative stress, and immune dysfunction, in improving endurance performance, and in reducing illness rates following periods of physiological stress.”
--David C. Nieman, DrPH, FACSM
Director, Human Performance Lab, North Carolina Research Campus
Professor, Appalachian State University

About Quercegen Pharmaceuticals

Quercegen Pharmaceuticals and its affiliates research, develop, manufacture, and market proprietary plant-derived pharmaceutical ingredients and nutraceutical products in the U.S and abroad. One of the Company’s affiliates, Quercegen Agronegocios, is the world’s largest producer of Quercetin and operates a 3,600 hectare farm in northern Brazil. It processes plant materials into crude Rutin and Quercetin for purification at its plant in Sao Luiz and the resulting purified products are shipped around the world for inclusion in pharmaceuticals, dietary supplements and foodstuffs.

Quercegen together with Merck S.A. developed QU995™, the World’s Purest Quercetin™, through a patented extraction and purification process. The Company has improved the bioavailability of the flavonoid Quercetin, through its patented QB3C™ formulation, which adds Vitamins B3 and C to its 99.5% pure Quercetin. This stabilizes Quercetin in water and boosts the natural bioavailability of Quercetin in circulating plasma, thereby significantly enhancing its therapeutic benefits.

Quercegen’s QB3C™ formula is contained in its first product on the market, Q-Force™, which has been tested by soldiers serving in the U.S. Military. Q-Force soft chews are currently sold online at www.qforce.com.

More information can be found on the Company’s web site www.quercegen.com

Contacts

Quercegen Pharmaceuticals LLC
Sean Scanlon, 781-728-3144
F: 978-451-0812
sean.scanlon@quercegen.com

Release Summary

Quercegen Pharmaceuticals is announcing FDA GRAS notified status for its QU995(tm) Quercetin and is launching a patented health formula through Q-Force performance soft chews

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Contacts

Quercegen Pharmaceuticals LLC
Sean Scanlon, 781-728-3144
F: 978-451-0812
sean.scanlon@quercegen.com