Nature's Little Pills

Forget everything you've heard about ancient sorcerers toiling to turn lead into gold. While a few glittery nuggets wouldn't have been unwelcome, many scholars say that the real goal behind alchemists' ultimately unsuccessful experiments was to extend life by defying age and disease, to find a formula that would combine base ingredients into the ultimate elixir of life.

From a quiet office in a corporate center off Old U.S. 41 in north Naples, and in satellite facilities around the globe, a company called HerbalScience is giving a 21st century spin to that medieval dream. Beginning in January HerbalScience is expected to introduce its group of herbal supplements to relieve a host of ailments, from anxiety to headaches to fatigue, with names like NuHerbal Pacifica, NuHerbal Abate and NuHerbal Gusto. Beginning with common herbs that have been used medicinally for centuries, company chairman Robert T. Gow and his team have used cutting-edge biochemistry research and manufacturing techniques to create and patent altered chemical profiles of these beneficial botanicals. With the ultimate goal of achieving FDA approval for its products, the company is determined to distinguish itself in a crowded but lucrative field that generated $4.4 billion in consumer sales in the United States in 2003.

The business of nutraceuticals, as herbal supplements are called, is starkly different from real estate investment and banking, Gow's fields before retirement. But he made

his first fortunes by moving on opportunities quickly, and that's what he intends to do with HerbalScience. The company is placing its products with distributors who supply the supplement market..

Gow has traveled often to China, where he worked with business and government interests as they looked for ways to expand free-market principles (Neapolitans might remember that Robert and Kay Gow's collection of Chinese art was one of the first exhibits at the Naples Museum of Art.) In China, Gow saw the huge market for traditional Chinese medicine, which uses medicinal herbs for the cure and prevention of disease. If known and tested herbs, with their long history, could meet the Western ideal of standardization, and if any questions about whether the herbs were toxic or harmful were addressed, these centuries-old therapies would benefit health-care consumers-and enrich those who brought the resulting products to market.

"This business venture has a great reward-providing new and inexpensive medicines with no side effects," says Gow. "The financial gamble to provide that solution is also large, but controllable."

Gow began the company in Naples in 2001. Besides Gow, principals include brothers John and Brian Pierce, both with doctoral degrees in chemistry and a long history of working with botanicals. (Brian Pierce, who holds 13 patents unrelated to HerbalScience, also holds a high-profile day job as technical director for an aerospace firm.) Longtime Fort Myers neurosurgeon George Sypert heads the firm's intellectual property division; and Gow's friend and fellow Chinese art aficionado, consultant Mechlin Moore, stepped in to create the company's initial marketing campaign.

In a storefront across the road from the company's headquarters, research and development head Dan Lin works at a small desk facing a wall, the dimly lit first floor of the office bare except for a couple of framed Broadway show posters. The visitor might be reminded of a Scooby-Doo cartoon when a door in the middle of the wall swings open to reveal an old-fashioned laboratory, complete with test tubes and Bunsen burners. With equipment that was ordered from around the world and assembled under a cloak of secrecy, Lin and her team developed the process. They take bins full of raw herbs, which are shelved in the back of the lab, and then extract, analyze and re-create their chemical profiles.

Lin, who received her doctoral degree from the University of China in Bejing, is the author of more than two dozen papers about the "supercritical CO2 extraction process," a method that uses compressed carbon dioxide to yield super-concentrated herbal extracts without chemical solvents. Other research has been conducted by scientists working for the company in China, Argentina (where the company also grows herbs) and Lehigh, Penn. Although research and development will be consolidated mostly in Naples, Gow expects to move most of the company's manufacturing to its Singapore facility.

The initial secrecy was necessary, Gow says, because the company's approach is very different from other supplement makers. According to a 2004 study conducted by the consumer research group Mintel, more than 900 companies sell homeopathic and herbal medicines in the United States. HerbalScience intends to sell its products in both the United States and Asia, where just the Chinese consumer market for herbal remedies is at least $10 billion annually.

Worldwide, gow says, further market growth has been hampered by the lack of standardization in dosages from supplement to supplement or even from capsule to capsule. "This variation is the weakness in herbal medicine," says Gow, who has taken supplements himself for decades. "The dose-to-dose dependability isn't there." Many supplements are merely repackaged herbs; and although the Food and Drug Administration cracks down on companies who make false claims, random analysis in various studies has shown that not all of these contain the herbs they say they contain. Even when the ingredients are pure, the effectiveness of the herb depends on the conditions under which it was grown-the health of the soil, the amount of sunlight and other factors.

The same natural variations that lend a fresh tomato its unique flavor or bring character to a cabernet are unacceptable in medicine. If you take a random capsule of an herbal supplement, "The odds are substantially in favor of you not getting a good one," Gow says. "And even then, if you do, [the dose] is not concentrated." There are also questions of toxicity related to taking certain herbs over a long period of time or in large doses. Kava, for example, was touted as an anti-anxiety wonder drug until 2002, when the FDA issued warnings about liver problems associated with its use.

There is also less potential for profit in simply repackaging herbs. Because herbs and plants can't be patented, there are no revenues associated with intellectual property. HerbalScience says it solves these industry problems-standardization and toxicity-with a process that also makes business sense for the company.

Lin and her team do this by beginning with a traditionally used herb, like kava (Piper methysticum), that has already been the subject of intense testing and academic research. "The chemicals have been identified, the efficacy is known," says Gow.

This profile also shows the chemicals that contribute to toxicity or that appear to be extraneous. In beneficial botanicals, Gow explains, the evolutionary process has often produced additional chemicals that are used as defenses against disease or insects. Often they can't be removed completely without also affecting the herb's medicinal properties. After using the supercritical extraction process to produce highly concen-trated herbal extracts, HerbalScience's researchers experiment with different levels of the chemicals in the herb until they arrive at a chemical profile that is as close to their ideal as possible. This altered chemical profile can then be patented.

In 2002, HerbalScience paid RT International, a North Carolina-based firm that offers pharmaceutical testing and other research for the National Cancer Institute as well as private companies, to analyze its kava-based NuHerbal Pacifica. RTI found that HerbalScience's product had significantly reduced amounts of the chemicals thought to be associated with liver toxicity. RTI also found that because the product is designed to melt rapidly in the mouth (a technique HerbalScience calls Herbalvescent delivery), there is less absorption by the liver and the chemicals hit the bloodstream right away. Herbal- Science has since been granted a patent for its method of cultivating the kava plant and has many patents pending, including one for its altered kava profile and one for oral delivery of a botanical.

Having the company's patents honored, Gow says, means "getting the scientific community to agree that we had made the breakthroughs we thought we had." In a field whose history goes back snake oil salesmen and mail-order tonics, basing his business on science, not folklore, was essential. "Credibility was a major issue," Gow says, "because it sounds too good to be true. There are so many charlatans in the business, people who make wild claims."

Further credibility, he says, comes from the presence of investors and working partners, including a relationship with one of Asia's largest chemical companies. HerbalScience has also been working with China's two largest drug-makers, including Tasly, a company that has been aggressive in its efforts to modernize traditional Chi-nese medicine and standardize products and practices.

HerbalScience is following FDA-approved manufacturing processes for its products, with the ultimate goal of having them approved as pharmaceuticals. Although it can take up to 15 years and hundreds of millions of dollars for a drug to move from research to approval, Gow says HerbalScience has an advantage, in that the medicinal value of the original herb is already known and the cost of the ingredients is relatively low. For now, the company will sell its products as nutraceuticals while beginning the extensive approval process. Gow says they will also supply other drug companies with their superconcentrated extracts.

The company is also eyeing a new location as part of FGCU's biotechnology center. It's a visible profile for a company ready to launch its products on the world, very different from its secretive beginnings. "People in Naples and the rest of the world did not know what we were doing here," Gow says. He knows other companies are racing to catch up. "There's an advantage to being first in this space. Although we will certainly have competitors, our technology is well-protected, and our chemical profiles are well-protected."