arGentis Pharmaceuticals LLC is gaining momentum to get its first two therapies to the marketplace with a $10 million-$12 million capital campaign, new paths for clinical trials and a renowned business accelerator firm to help it find a drug development partner.
The Memphis pharmaceutical company is now negotiating with a clinical research organization to begin a Phase II trial of its dry eye therapy. That trial would take six weeks and company officials are hoping to conclude it in 2009. It would be followed by a lengthier Phase III trial. The therapy is projected to hit the market in 2013.
The company has filed applications in 50 global markets to give its scleroderma therapy extended patent protection since it’s the only one of its kind. That therapy was given orphan status by the Food and Drug Administration. This will allow the company seven years of market exclusivity after its introduction.
If the EMEA, Europe’s FDA, allows the distinction, it would protect the company’s patent from generics companies for 11 years in Europe. Officials hope to have the designation by the end of this quarter. The company’s scleroderma therapy was developed by University of Tennessee Health Science Center researchers Arnold Postlethwaite and Andrew Kang.
To move the company closer to these and other goals, it is seeking to raise $10 million-$12 million. Some of those funds will be used to hire a probably four-person management staff. arGentis chief accounting officer Ted Townsend says this has been a key target for the company all along.
“(CEO Tom Davis and I) have taken the company pretty far for all these years, but we realize that now is the time to bring in regulatory experts, CFOs and CEOs that have experience in pharmaceutical development,” Townsend says.
The goal of the company, Davis says, has always been to find business partners to help develop and market therapies in its clinical pipeline. To help it get there, it has contracted with Brentwood, Tenn.-based JRG Ventures LLC. That company specializes in business development and growth strategies for biotechnology companies like arGentis. CEO Keith Gregg says JRG won’t engage a company until its technology is mature enough to be licensed by another. arGentis, he says, is ready.
“We have a daily, escalating interest in what’s going on and several companies interested in talking about partnering with them on the technology,” Gregg says. “Their therapies are in totally different markets, but they’re high-demand markets.”
While it’s difficult to determine the exact size of a portion of a health care market, Gregg says he estimates the dry eye market to be “in the hundreds of millions.” The scleroderma treatment would be the only drug on the marketplace to treat the underlying causes of the disease for roughly 160,000 patients in the U.S. and the E.U.
University of Tennessee Health Science Center researchers discovered a method earlier this year to determine which patients would actually respond to treatment for scleroderma at all. This “revolutionary” method will allow the company to pick better patients for the therapy’s final clinical trial.
arGentis filed a patent application for the diagnostic method in July.