Argentis anticipates landing fast track for drug approval

Pharmaceutical firm develops autoimmune disease treatment

The Commercial Appeal
February 9, 2008
By Daniel Connolly

The federal government has granted orphan status to an experimental treatment for a fatal autoimmune disease, a step that could speed its approval and will bring financial incentives to Memphis-based startup Argentis Pharmaceuticals LLC, the firm that is developing it.

The decision is a boost for the small company, which is designing treatments based on local university research. Like many startup drug companies, Argentis isn't making any money, said vice president and chief administrative officer Ted Townsend. The financial incentives and possible acceleration of the approval process could improve the firm's chances for survival and profitability.

The Argentis treatment that got orphan status is called ARG201 and is meant to fight systemic scleroderma, a rare and often fatal disease in which the immune system attacks type 1 collagen, a protein found in every tissue in the human body.

The immune system's attacks prompt the body to produce even more collagen, which can cause fatal damage to internal organs. About 80,000 people in the United States have the disease, and there is currently no treatment, the company said.

Dr. Andrew Kang and Dr. Arnold Postle-thwaite at the University of Tennessee Health Science Center have studied systemic scleroderma and are helping Argentis develop ARG201, a highly purified form of type 1 collagen derived from the skin of fetal calves.

They believe that if patients swallow this collagen, their digestive tracts will make chemicals that reduce the immune response.

The government uses orphan status to encourage companies to develop treatments for conditions that affect fewer than 200,000 people, said Food and Drug Administration spokesman Christopher C. Kelly.

The orphan status makes Argentis eligible for tax breaks and the FDA will waive a large fee associated with the drug application process, he said.

If the FDA approves ARG201, Argentis would have seven years to market it before generic competitors are allowed, rather than the normal five years, Kelly said. Orphan treatments can receive faster approval than others because the agency often speeds up their review, especially for life-threatening diseases, according the FDA Web site.

Kelly said Argentis treatment still has to go through the normal series of tests, and said he wouldn't speculate on how fast approval could come.

The firm recently completed a 168-patient trial and Townsend said the company is now working with the FDA to set up a larger test.

Once the firm knows how big the next trial will be and how much purified collagen it will need, it can finalize plans to build a collagen-producing factory in the Memphis area, Townsend said. David Brand, a research biologist who works at UTHSC and the Memphis Veterans Medical Center, is playing a key role in the production process.

Townsend wouldn't discuss the firm's finances in detail, but said it's running on contributions from him and the other principals, Tom Davis and Buddy Lyons. The company is halfway through an effort to raise $2 million from investors, he said.

Argentis is also developing hormonal treatments for dry eye syndrome that are based on research at the Southern College of Optometry. Townsend said the firm is talking with other companies about licensing agreements.

- Daniel Connolly: 529-5296

Argentis Pharmaceuticals LLC

The firm writes its name as "arGentis."

President and CEO: Tom Davis

Employees: Three, plus consultants and collaborators

Address: 20 S. Dudley, Suite 806

Web site: argentisrx.com