SAN DIEGO, California -- They say the biotechnology revolution is here. But before it can be won, the biotech industry has a tough economic battle ahead.
A recent study by Accenture, a research and consulting firm, found that in order to maintain double-digit growth in earnings, revenue and shareholder value -- which various companies have promised -- companies will have to cut the $500 million to $600 million it takes to bring a drug from research to market by at least half.
Pradeep Banerjee, a partner at Accenture who focuses on biotech research, said it can be done, but it won't be easy.
"The key theme is convergence of science and information technology," Banerjee said Tuesday at the Bio2001 conference in San Diego.
Pharmaceutical companies also need to bring between five or six new drugs to the market every year, instead of only one or two, to meet the financial goals promised by the industry, Banerjee said. And pharmaceutical companies must significantly change the structure of their internal operations to reach drug delivery goals.
One company presenting its technology at the conference said it has a unique way to cut costs. Instead of building expensive manufacturing plants, Epicyte's plan is to engineer corn crops that can manufacture antibodies against human diseases into the seeds. As the plants grow, they will produce the antibodies.
Unlike other companies creating hardier seeds with genetic engineering, the corn that Epicyte grows will be ground up and then distilled from the kernels to go into topical treatments.
Mitch Hein, Epicyte's founder and president, said the company holds three patents on their "Plantibodies" technology. If all goes well the first treatment, a herpes vaccine, will enter clinical trial by the end of 2002.
With about 200 acres of corn, the technology could produce the same amount of an antibody as a $400 million production plant.
But first the corn must grow, and the FDA must test the drug. Hein said he doesn't expect any big problems with the approval process even though the plant-produced medicines could present unique characteristics. The FDA has already tested "humanized antibodies" made partly from animals such as the mouse, he said.
The company is working on four other antibody products to treat infectious and sexually transmitted diseases, including a contraceptive gel that Hein said could be used in conjunction with condoms.
Prodigene is another company growing medicines in plants, a field that's become known as "biopharming."
Prodigene is one of the few companies at the conference with a product already on the market: a plant that produces proteins used in industrial research.
Anthony Laos, president and CEO of Prodigene, said a plant-manufactured protein called "Protenin," the company plans to enter clinical trials with one product in about six months. The drug would be a therapy for wound-healing and heart transplants.
The company is also working to develop edible vaccines in plants.
Although they face criticism from opponents of genetically engineered food, their products could be a savior for underdeveloped countries that don't have the facilities to refrigerate vaccines.
Prodigene has developed its own containment system for their genetically modified corn crops, called the "Identity Containment System," on which they've filed for a patent.
"We don't want our products to be mixed with the food supply," Laos said.
Protests against genetically modified foods have been fewer than expected at Bio2001, but present nonetheless. Most protesters cite corporate greed as a big complaint.
Most previous genetic engineering in plants has been to find a cheaper way to make crops more resistant to blights and insects. Opponents say the unknown risk to human health and ecology aren't worth it.
The companies hope that viable products that benefit human health could help the industry gain some ground in what seems to be a losing public relations battle.
So far, the tactic hasn't worked for Syngenta, the company developing Golden Rice, which is genetically engineered to contain vitamin A.
Vitamin A deficiency is common in the Third World. It affects up to 200 million children and causes up to 1 million deaths and 1 million cases of blindness every year.
But opponents say that Golden Rice is compounding a problem that groups such as the World Trade Organization caused in the first place.
According to Sam Prentice, a graduate of the University of California at Davis program in international agricultural development and soil science, because the WTO encouraged farmers in Southeast Asia to grow more rice so they could export it for a profit, eventually farmers were producing only rice and none of the green leafy vegetables that also contain vitamin A, Prentice said.
Still, the biotech industry hopes that biopharming will not only be cost-saving but also an image-saving step for agricultural biotechnology.
