Ready for a big breakthrough

Published 9:00 pm Sunday, April 3, 2005

BOTHELL – JBNI Inc. has quietly developed and sold nonprescription, natural-based remedies for more than a decade, but its newest potential drug could bring the company much more attention.

The company recently received an investigational new drug designation from the U.S. Food and Drug Administration for its new asthma treatment. At the same time, JBNI is talking with possible pharmaceutical partners and investors who could help shepherd the drug through the rest of the expensive federal approval process.

Located in Bellevue until March, JBNI admittedly is a bit of an odd duck amid the flock of biotech companies centered in Bothell’s Canyon Park area.

Its focus on natural and herbal-based drugs and remedies may seem out of place with the cutting-edge laboratories down the street where clinical researchers manipulate molecules.

But Grace Szczepaniec, JBNI’s general manager, said natural-based drugs can be just as effective as bioengineered ones. As a budding biotech, it made sense for JBNI to settle in south Snohomish County, she said.

“We picked Bothell because we wanted to be where the biotech companies are, the pharmaceutical companies are, and where the FDA, which we work with a lot, is,” said Szczepaniec, who lives in Mukilteo. “This is the place to be if you’re going to be working in research and development.”

Despite only recently drawing attention, thanks to its potential asthma drug, JBNI has been around since 1993, although under different names. That’s when Sung Baek, whose background includes more than 30 years in the medical research field, founded the company based on research he conducted with several other scientists.

Baek, JBNI’s chief executive officer, then led the research and development of more than 20 specialized natural supplements and remedies for a variety of conditions including migraines, pain and inflammation, and menopause.

“Everything that our company produces is absolutely, completely natural, with no adulteration of any kind,” Szczepaniec said.

It’s a realm of health care that’s gotten a hazy reputation, thanks to the retail sale of herbal-based supplements, which don’t come under the FDA’s scrutiny. JBNI seems painfully aware of that fact as it tries to differentiate itself.

Unlike other nonprescription herbal remedies, JBNI’s products aren’t sold directly to big drugstores and health food outlets. Instead, Szczepaniec said, the company sells directly to doctors, pharmacists and other practitioners.

“It’s in line with our policy to sell only to medical professionals,” she said.

The new asthma drug is naturally based, but JBNI decided to take it through the full FDA approval process as a prescription drug candidate. That should raise the profile of both naturally-based drugs and JBNI.

“The approach that JBNI has taken – I really applaud them – is to say they’re going to set a higher bar,” said E.J. Lovett of Lovett Collins Associates, who is overseeing the asthma drug’s phase 3 clinical trials in Maine.

The double-blind trial at the University of New England’s College of Osteopathic Medicine is testing the drug candidate’s potential effectiveness in treating asthma. Earlier tests showed positive signs, Lovett said.

“The trials that have been completed look very promising,” he said. “All the preliminary indications certainly justify going forward.”

Assuming results from the ongoing trial also look good, JBNI hopes to begin the new drug application process with the FDA.

Nearly 18 million Americans have asthma, so the drug’s potential has attracted interested parties to JBNI, though it still could take years before the drug wins final approval.

In the meantime, JBNI hopes to grow. Right now, the staff amounts to just three, including Baek, as all of the company’s research is done by outside contractors. By the end of the year, the company hopes to hire up to 20 employees, Szczepaniec said.

Baek said he would also like to develop other treatment candidates that can be developed into FDA-approved, marketable drugs like the asthma product. At this point, however, he has no plans to have his privately held firm transform itself into a public company.

Reporter Eric Fetters: 425-339-3453 or fetters@heraldnet.com.

Jennifer Buchanan / The Herald

Grace Szczepaniec, general manager of JBNI Inc., recently moved the business to Canyon Park in Bothell from Bellevue. JBNI develops and distributes natural-based medicines.