By Steve Sternberg

Special To BioWorld Today

Some people mine the earth for gold. Some biotech pioneers are seeking it in a more prosaic place. Theirs is a different sort of gold. Nonetheless, it may prove quite valuable.

This gold is human urine. Each day, millions of tons are flushed away worldwide. Yet if a fledgling firm called OriGene Technologies Inc., in Rockville, Md., and Shanghai, China, can master the alchemy needed to transform this gold into new therapeutic substances, many people besides the company’s stockholders may someday reap the benefits.

“We’re purifying a protein that has antitumor activity, and we’re interested in a protein that can control appetite,“ Wei-Wu He, the company’s CEO, told BioWorld Today. “We may just go ahead and clone every protein in human urine.“

Odd as it may sound, OriGene’s strategy is based on a basic, if inelegant, fact of human biology. As a company profile boldly states: “urine is a rich source of pharmaceutical products.“

Take, for instance, the biotech drug erythropoietin, or EPO. This substance, which bolsters the erythrocyte content of human blood, was originally identified in — and purified from — human urine. Worldwide sales of EPO exceeded $1.5 billion in 1995 alone. The same year, sales of human menopausal gonadotrophin (hMG), which is extracted from the urine of postmenopausal women and used to remedy infertility, reaped $500 million.

OriGene plans to bolster its cash flow by building a business based on some of these existing products. Wei-Wu He — who was one of the first researchers at Human Genome Sciences Inc., of Rockville, Md. — said OriGene now is negotiating a multimillion dollar deal with Serono Laboratories Inc., of Norwell, Mass., and Rome, Italy. Under the terms of the agreement, he said, OriGene would provide Serono with 200 million units of crudely purified urine. Serono would further refine the urine into quantities of hMG at an Italian manufacturing facility. The company’s hMG sales total $300 million a year.

“Right now, there’s a worldwide shortage of hMG because they’re running out of urine,“ he said. “This would help the whole in vitro fertilization field.“

OriGene will also be producing human chorionic gonadotropin — a hormone used to stimulate ovulation and fertilization — valued at $150 million in the U.S. “We’re basically doing the dirty work for them,“ Wei-Wu He said.

A Limitless Supply

And the supply of raw material is virtually limitless. The challenge is logistics: getting the urine and transporting it to a processing plant. OriGene’s Chinese subsidiary, Benifitu, can collect 40 tons of human urine a day, OriGene officials estimate. Such quantities are essential, because it takes 50 tons of urine from postmenopausal women to generate a million units of hMG. (An average postmenopausal woman excretes just 500 milliliters, or a pound of urine a day.)

Wei-Wu He said Benifitu — which is owned by OriGene, some individual investors and the Chinese government — will contract with local waste collection units to hire women who will be supplied with a tank and collect urine door-to-door. The women will then empty their tanks into cisterns, where it will be collected and taken to a factory in Shanghai for processing.

One of OriGene’s founders, Dexu Zhu, a former dean of the Nanjing School of Life Sciences, has more than 20 years of experience in the industrial purification of urinary proteins, according to the corporate profile.

The company also plans to develop its own products — one of which is also derived from womens’ urine. “We believe hormones regulate appetite,“ Wei-Wu He said. “When women get pregnant they are driven to eat by a hormone. We believe that a pregnant woman’s urine has this hormone. We are actually injecting pregnant women’s urine into mice to see if it changes their diet.“ If OriGene can identify such hormones, company scientists will sequence their peptides and clone their genes. “Any one could become a billion dollar product,“ Wei-Wu He said.

Next Up: Traditional Herbal Remedies

OriGene also hopes to tap into a wealth of herbal remedies used in traditional Chinese medicine. Just as many Chinese doctors willingly acknowledge the successes of Western medicine, many Western physicians say the Chinese have proven adept at treating a range of illnesses — though they have yet to produce the randomized, double-blind studies that Western cultures demand as proof of efficacy.

Nevertheless, Chinese remedies “will no doubt provide Western scientists with new pharmacologically active agents,“ wrote David Eisenberg, a Harvard University-trained physician, in “Encounters with Qi,“ a book about his medical studies in China. “We’re trying to Westernize traditional Chinese medicine,“ Wei-Wu He said.

OriGene has begun to study snake and scorpion venoms in an effort to purify the proteins and clone the genes that produce them. “In China, scorpion venom is used to treat epilepsy,“ he said. “It’s a calcium channel blocker. We are trying to clone the gene.“

The firm has also made arrangements with the Chinese government to obtain 10,000 of the herbs used in traditional medicines. OriGene plans to extract their components using organic solvents and establish a battery of potential medicinals for further research. “We want to identify leads that put us into a position to be an early stage drug company,“ Wei-Wu He said. “Our strategy is to farm out these leads to larger pharmaceutical companies.“