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Univera's Scientific Advantage
by Stephen Cherniske, M.S.
Chief Scientific Officer
Univera USA

An Honest View
For too long, nutrition was the stepchild of the biological sciences. When I began my research in the early 1970s, it was part of Home Economics, ridiculed as the Betty Crocker school of Nutrition. Then, in the 1980s, a growing body of research began to change the tone of that discussion, focusing on the critical role that diet and nutrition played in immunity, cardiovascular health, diabetes, cancer, and aging.

As the trickle of research grew to a torrent, I was sure that nutrition would take its rightful place as equal in importance to pharmacology. After all, drugs had an important role to play in health care, but it was clear to everyone that the keys to prevention were to be found in the natural products arena.

And yet, as we entered the 1990s, the nutrition "revolution" was stalling. There were three important reasons for this:

1. Lack of funding. In a profit-oriented system, success is tied to patents. It is easy to obtain patents on synthetic molecules because they are by definition, unique. Thus, as the pharmaceutical companies amassed thousands of patents, the natural products arena was left behind. From 1985 to 1995, more than 10,000 patents were awarded to the nine largest drug companies, creating the most profitable business in the world.

2. Money buys power and influence. By 1996, according to an ABC News report, "The pharmaceutical industry had more registered lobbyists than the number of senators and congressmen combined."

3. Lack of scientific integrity. If the natural products industry has been under attack by government and the media, much of the criticism is self-inflicted. I know of no other industry (not even used cars) that is plagued by more exaggeration, hype, and outright lies. In my academic career at two southern California universities, I was at odds with both sides of the health care spectrum. I would plead with the biomedical departments to look at the wisdom inherent in centuries of medicinal plant use. And at the same time, I would challenge natural product advocates to support their claims with reliable science.

The Problem: Reliable science is expensive.
We must remember that, in addition to record profits, the pharmaceutical industry has enjoyed another source of funding. The National Institutes of Health (NIH) spends more than $20 billion annually on research. A 1995 report by that agency looked at the five top-selling drugs, and found that "NIH-funded research played a critical role" in developing each one.

Without massive profits or taxpayer dollars, the natural products industry would need a philanthropist. Enter Bill Lee, a South Korean business leader who had purchased a Texas Aloe plantation in 1988. From 1988 to 1995, the Lee family funded more than $4 million in university research on Aloe vera alone. In 1996, he started his own laboratory (known as Unigen) and poured another $20 million into medicinal plant research. When I met Bill Lee in 1997, he explained his business plan: to set the bar for the natural products industry by utilizing advanced technologies then available only to pharmaceutical companies and large universities. To my amazement, all this would unfold in less than a decade.

Milestones:

1997:
- Began medicinal plant collection and analysis with 500 species from China and India
- Unigen awarded U.S. patent for the use of Polymerase Chain Reaction (PCR) analysis of Aloe vera

1998:
- LCMS and GCMS technologies added to Unigen's biological and biochemical capabilities
- Univera incorporated to distribute products developed by Unigen research
- Lee purchases an option on more than 140,000 acres in southern Siberia, including a 100,000-acre botanical preserve
- Unigen develops MaxCell, a botanical extract to enhance nutrient bioavailability. In vivo data shows 300 percent increase in CoQ10 bioavailability (U.S. patent #6,395,311)

1999:
- Phytologix research platform developed, with high throughput analysis of more than 1,000 medicinal plants
- Unigen researchers publish detailed in vivo analysis of Aloe metabolism (Yagi)
- Univera launches MetaBerry, the first high-potency antioxidant beverage, combining concentrates of blueberry, cranberry, black cherry, and concord grape in an Aloe delivery system. ORAC score: 2,000 per fl oz.
- Univera launches Prime, combining DHEA, 7-Keto, DIM, alpha lipoic acid, acetyl-L-carnitine, N-acetylcysteine, goji concentrate, B2. B6 and methylcobalamin

2000:
- Unigen and Univera scientists present research foundation for the metabolic model of aging (Jia, 2000)
- Unigen scientists identify immunomodulatory "sweet spot" among thousands of Aloe polysaccharides (Qiu)
- Phytologix library expanded to include 2,000 plants from four climate zones

2001:
- Unigen adds genomics technology with 96-well plate capabilities, becoming the first natural product R&D facility utilizing full-scale genomics
- Unigen scientists document age-related decline in tissue repair, measured by urinary metabolites (Jia 2001) Patent issued (U.S. Patent #6,326,209)
- Univera adds alpha-lipoic acid to MetaBerry, increases ORAC score to 3,000 per fl oz.

2002:
- Phytologix plant library expands to 3,000 plants and 20,000 fractions
- First U.S. Patent filed for a defined combination of Scutellaria baicalensis and Acacia catechu #10/091,362
- Unigen creates Protectin, a standardized extract of Scutellaria baicalensis and Acacia catechu.
- Univera launches Ageless capsules, combining ornithine alpha-ketoglutarate, B6, Panax ginseng, Eleuthero, rhodiola, green tea, Protectin, and MaxCell

2003:
- The Metabolic Plan published by Random House, finalizing the Metabolic Model of Aging and coordinating Unigen research with Univera product development
- First paper confirming in vivo anti-cancer activity of orally-administered Scutellaria baicalensis (Zhang)
- Univera combines Ageless capsules and MetaBerry to create AgelessXtra. Achieves antioxidant potency of 4,500 ORAC per fl oz.
- Univera launches RegeniCARE, combining Protectin, glucosamine, chondroitin, MSM, and CMO

2004:
- ECONET incorporated to coordinate operations of all Lee entities, including agriculture, research, manufacturing, and distribution
- Unigen genomics program expanded to include microarray capability, allowing for the screening of up to 1,500 genes at once
- Bill Lee becomes the world's leading supplier of Scutellaria, planting more than 2,000 acres
- ECONET files record number of patents (42) in eight areas of natural products research

2005:
- Lee purchases 1,200 acres on Hainan Island, China, for Aloe plantation, including five miles of beachfront on the South China Sea for a holistic health spa
- U.S. patent issued for antioxidant activity in Aloe chromones (US Patent #6,884,783)
- U.S. patent issued for the use of Acacia catechu to reduce COX/LOX- mediated tissue damage (US Patent # 7,108,863)

2006:
- Phytologix library expands to 6,000 plants and 100,000 fractions
- Univera launches Essentials, a comprehensive meal replacement utilizing unprecedented food science:

A. Nanotechnology to create water soluble essential fatty acids (from cranberry seeds)
B. Ultrafiltration and enzyme hydrolysis to reduce protein to di- and tri-peptides
C. Non-gelling soluble fiber
D. Minerals from whole food concentrates

2007:
- Publication of pivotal efficacy paper for Protectin in the Journal of Medicinal Food (Burnett)
- Publication of Protectin safety study in the Journal of Food Biochemistry (Burnett 2007)
- Patent awarded for the activity of free-B-ring flavonoids to support joint repair (US Patent # 7,192,611)
- Univera launches RegeniFREE, combining Protectin and a standardized high potency extract of curcumin

2008:
- Unigen installs Proton Nuclear Magnetic Resonance (PNMR) laboratory
- 90,000 sq ft Hainan Aloe processing plant goes on line
- Unigen conducts comprehensive gene array studies of Protectin and Aloe vera; Identifies important new health-promoting factors

Conclusion:
Today, ECONET comprises one of the largest and best-equipped natural products R&D operations in the world, coordinating research activities with:

- Georgetown University
- Baylor University
- University of California, Irvine
- University of California, Davis
- University of Illinois
- University of Wisconsin

- ECONET laboratories now total more than 100,000 sq. ft., including full-scale genomics, proteomics, biological, biochemical, organic synthesis, quality control, and PNMR facilities.

- 50 Full-time scientists, including 20 PhDs, with expertise in biochemistry, botany, analytical chemistry, cell biology, molecular biology (plant and animal), human nutrition, pre-clinical and clinical research, organic synthesis, and process development.

- More than 7,000 acres under cultivation, with farms and fields in the U.S., Mexico, Russia, China, and South Korea. Agricultural operations in every climate zone, including a 100,000 acre botanical preserve.

- Over 160 patents awarded or pending.

- Phytologix library now contains 9,000 plants and 250,000 fractions, with 1,000 plants being added every year.

- ECONET agricultural division now produces more than 30 percent of the world's raw material Aloe.

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