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What a way to start the spring. First Peter Johnson's Agouron Pharmaceuticals on North Torrey Pines Road wins FDA approval to begin marketing its anti-AIDS drug Viracept, then his neighbor Art Benvenuto and his Advanced Tissue Sciences receive FDA blessings to use their Dermagraft-TC to replace the skin of severely burned people. Meanwhile, Bruce Ahern, publisher of the Technology Directory, discloses a tally showing that San Diego’s biosciences have regained employment momentum, growing by 3.2 percent or 670 jobs to 21,290 total by year-end 1996, reversing a 1 percent decline in 1995, but still off the 11 to 18 percent annual pace of the early 1990s. "Let the good times roll," bubbles Bill Otterson, the UCSD Connect director and high priest of high technology. Such FDA milestones shed "positive light" on San Diego "as the place where these developments took place," says Otterson, "and could lead a procession of other FDA approvals." Not that the FDA gives a hoot where an applicant operates, but the FDA does have pending a handful of final product applications from locals Idec Pharmaceuticals, DepoTech and Isis Pharmaceuticals, and the continuing attention reinforces San Diego as a happening place in the minds of bio-venture capitalists, big drug companies and medical manufacturers. And scientists. And techies. And students. Success attracts money and talent. Analysts put the market for Advanced Tissue's substitute skin product at about $30 million in the U.S. and $70 million worldwide annually for third-degree burn victims. About 1,500 such patients are struggling in the United States at any one time. Conventional treatment calls for the transplantation of cadaver skin, a terrible prospect that introduces infection and rejection more often than Advanced Tissue's Dermagraft. This isn’t a big market to help Advanced Tissue recover more than $120 million invested in research and development in the last decade, but with good science and good luck, the market won’t stop there. Following the FDA's approval of this first-ever human-based tissue-engineering product to be commercialized, Advanced Tissue is counting on the FDA to expedite approval of its Dermagraft-TC process for less severe burn victims, a worldwide market estimated at $300 million annually. But the big economic benefit will come if the FDA approves similar Advanced Tissue technology to treat diabetic foot ulcers, a $2 billion annual market worldwide. If Advanced Tissue were to capture only 10 percent of that market, the company will become substantial. And still there's more potential. As Advanced Tissue is growing skin from human cells, it is growing cartilage for articular resurfacing. Instead of the current practice of removing damaged cartilage from a bad knee and replacing it with nothing, Advanced Tissue's technology would replace it through arthroscopy with custom-grown cartilage. Advanced Tissue has submitted an investigational device exemption application to the FDA and plans to start human clinical trials later this year. Final FDA approval of cartilage growing for human therapy is still years away. "The whole notion is to redefine the way tissue repair and transplantation are done throughout the world," says Advanced Tissue's Benvenuto, a veteran of Ivac and Eli Lilly. On North Torrey Pines Road, Benvenuto is expanding Advanced Tissue's skin manufacturing facility, which now employs 50 of his 200-or-so people. By the end of this month, he should begin shipping the first commercially sold artificially grown skin to help some poor soul recover from burns. Analysts predict first-year sales of $2 million to $4 million. "One step at a time," says Benvenuto. "No one but Mother Nature was able to do what we’re doing. We’re starting off in a modest market that will grow as we add new indications. Keep in mind, this was not only the first bio-engineered human tissue, but this was also the first time the FDA approved a facility of this type. We’re not only redefining tissue repair and transplantation, we’re creating an entirely new industry." |