Washington Editor

NEW YORK - America's changing population demographics present obvious opportunities for the drug industry, some of which were discussed during the last day of the BIO CEO and Investor Conference.

"The population is getting older, and it's getting sicker," said Michael Werner, the president of the Werner Group, a Washington-based consulting firm. Chronic and costly ailments, such as cardiovascular disease, diabetes, Alzheimer's and osteoporosis create a "tremendous need" for new therapies, he said.

Those types of conditions are associated with "extraordinarily high costs," he added, so even though new drugs might be expensive, they should provide broader savings to the overall health care system as interventions for such persistent problems, so-called diseases of longevity.

One company targeting research in cardiovascular disease, Alteon Inc., of Parsippany, N.J., has advanced a drug through a pair of Phase II studies for diastolic heart failure. The condition, called "a major contributor" to mortality and health care costs by the company's president and CEO, Noah Berkowitz, is marked by heart muscle thickness that prevents it from adequately filling with blood.

The product, called alagebrium, is designed to address diastolic heart failure by decreasing that thickness, and data from the two trials indicated its effectiveness. In one study, the drug produced decreased heart masses, and in the other study, it improved diastolic function.

An Alzheimer's compound that's generated positive clinical results, TC-1734, was discovered through Targacept Inc.'s internal research on neuronal nicotinic receptors and now is moving forward in partnership with AstraZeneca plc.

A Phase IIb study of the drug in age-associated memory impairment hit all three endpoints, which were related to attention, memory and overall functioning. Looking ahead, AstraZeneca, of London, is eyeballing larger trials to test TC-1734 in mild to moderate Alzheimer's and schizophrenics' cognitive deficits. Clearly, the drug is being positioned for what Targacept President and CEO Donald deBethizy called "huge and growing market" opportunities.

Osteoporosis represents another disease manifested in the elderly, and because of the U.S.'s aging population, "this problem is likely to only increase," said Brian MacDonald, the CEO of Zelos Therapeutics Inc. The company's product in the space, Ostabolin-C, helps bone formation without increasing bone resorption.

Early Phase II findings, gleaned from a peak into bone growth four months into a year-long trial, demonstrated the drug's bone-building capabilities relative to baseline. The fact that this effect is being seen so quickly "is really very satisfying," MacDonald said. Ostabolin-C should move into Phase III in about a year.

An earlier-stage compound with a positive cardiovascular disease profile is being advanced by Elixir Pharmaceuticals Inc. Labeled EX-1350, the ghrelin antagonist works in a pathway called daf-2 that plays a role in metabolic function.

Advanced preclinical evaluations, which will enable an investigational new drug application down the road, have demonstrated a range of beneficial impacts, including lower body weight, reduced insulin resistance and decreased cholesterol levels. William Heiden, the company's president and CEO, said Type II diabetes represents an initial development direction for EX-1350, with longer-term plans for obesity and lipid disorders.

In addition to those myriad diseases associated with age, there also is a market segment that addresses the appearance of age, said Don Kleinsek, the CEO of GeriGene Medical Corp.

The firm is developing a cell therapy to help eliminate wrinkles and correct scars, as well as treating urinary incontinence and acid reflux. "Old cells work just fine," he said, and all those applications for cell therapy represent large market opportunities that can be reached quickly. That's because the company's development timelines and costs are far lower than more traditional drug therapies.