Addrenex aims for fast track

Relatively young for drug company, it plans to create drugs to counter adrenaline

Addrenex is an odd duck among the dozens of biotech companies in the Triangle.

In an industry notorious for high costs, high losses and high risks, the privately owned Durham drug development company hopes to bring two products to market and generate profits as early as next year, just three years after being started.

Moise Khayrallah, Addrenex's chief executive and co-founder, plans to accomplish that task with four full-time employees, a dozen contractors, $700,000 in investments and a partnership worth $6 million.

"I've always felt that drug development is costlier and more work-intensive than it ought to be," Khayrallah said.

His secret? The company keeps development work in-house. That includes designing, managing and tracking trials, talking to the Food and Drug Administration and writing regulatory requests for the approval of new drugs.

Many other biotech companies tend to farm all or part of that work out to contract research organizations, or CROs, which have an interest in driving up costs, Khayrallah said. He should know. He worked for a CRO and a large drug maker.

What Khayrallah hasn't figured out is how to reduce the risk of drug development. Addrenex aims to develop medicines that counter the effect of the stress hormone adrenaline. Any of its drugs could fail in clinical testing, suffer regulatory setbacks or generate disappointing sales.

The first two drugs in development are new versions of Clonidine, a hypertension treatment that has been on the market for decades. Addrenex's first version also targets hypertension; the second is a treatment for attention deficit hyperactivity disorder, a commonly diagnosed behavioral disorder.

CloniBid, the hypertension version, may become available in early 2009. Clonicel, the ADHD version, may follow later that year.

Both drugs would be sold by Sciele Pharma, an Atlanta company specializing in treatments that improve the health of women and children. Sciele announced a year ago that it would team with Addrenex and invest $6 million to test Clonicel.

In December, Addrenex took steps to expand its pipeline of promising drugs. An agreement with the University of Nebraska Medical Center gives the company access to a collection of 400 potential medicines.

Khayrallah is looking for about $12 million in venture capital to start testing the first one in humans by the end of the year.