GOLDSEA | ASIAN AMERICAN PERSONALITIES

BIOTECH GOLDENBOY
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     The second drug DLI has licensed for development through its 75%-owned subsidiary Acute Therapeutics Inc (ATI) is KL4-Surfactant. A surfactant is a protein-phospholipid complex, either natural or synthesized, that prevents the collapse of the lung's delicate air sacs by lowering surface tension as you breathe out and raising it as you breath in. Currently replacement surfactants are used mainly to treat infant respiratory distress syndrome (IRDS). DLI is pursuing FDA approval to use KL4-Surfactant for the treatment of adult respiratory distress syndrome (ARDS) and meconium distress syndrome (MCS), another infant respiratory condition. Later, DLI hopes to expand the use of KL4-Surfactant to treat IRDS.

"The U.S. pharmaceutical community has focused more on the bisphosphonate class, so we're in a position to take [vitamin D analogs] from the rest of the world to the U.S."

     The third compound DLI has licensed is ST-630, a vitamin D analog for the treatment of postmenopausal osteoporosis. Again, DLI has chosen a compound that has been well tested. Vitamin D analogs have been in use throughout Europe and in Japan for osteoporosis and are the world's most commonly used therapy for treating that disease, though in the U.S. the field is dominated by bisphosphonates. ST-630 itself has already undergone the equivalent of Phase II clinical trials in Japan where it has been licensed by Sumitomo and Taisho.
     In Kuo's opinion ST-630 is potentially the biggest of its three projects. For one thing, osteoporosis affects 20 million women in the U.S. alone, a potential market that's a couple of order of magnitude larger than for DLI's respiratory drugs. Kuo's values the U.S. osteoporosis market at several billion dollars.
     "It's equivalent in size to the hypertension market which supports several major pharmaceutical companies, including Pfizer and Merck," says Kuo. "It's a huge potential market. We think we have the leadership position with this class of drugs, vitamin D analogs."
     Vitamin D analogs may soon replace the bisphosphonates currently in vogue in the U.S., Kuo believes.
     "There's controversy with the bisphosphonate class of drugs," he says. "The FDA used to regard increased bone mass as beneficial. When Proctor and Gamble ran a clinical trial with their drug, it increased mass but after year three there was actually increased fractures. It was basically low-quality, non-structural bone. That caused the FDA to rethink the way they evaluate compounds for the entire osteoporosis class. They began relying more on fracture data which greatly increased the cost of development. Merck has been able to show decreased fractures [with its bisphosphonate-based drugs under development] but you'll find orthopedic surgeons in the field who'll say it's only a matter of time before that occurs."
     Even more encouraging for Kuo is an article published in late 1996 in the New England Journal of Medicine.
     "Merck's Fosamax [can] cause a hole to be burned into the esophagus, which is very serious and causes patients to be checked into the hospital and possibly have surgery. And their drug has to be taken first thing in the morning with a full glass of water. Then the patient has to sit up straight for a half hour or an hour and then eat a full breakfast. Otherwise you could suffer the effects of chemical esophagitis. It's very cumbersome. We're not sure what the future holds for the bisphosphonate class. If they turn out to be safe and efficacious, it's still fine because you look at the hypertension field, there are three or four classes of drugs which are available.

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