Jul 1, 2018

Zurex Pharma moves toward filing for FDA approval of its surgical antiseptic

Source: Judy Newman | Wisconsin State Journal

Zurex Pharma, a Middleton company with a new type of antiseptic for surgical wounds, is getting a boost from investors as it prepares to file for approval of its first product from federal regulators.

Zurex has added $9 million to its coffers, raising the total received so far to $28 million.

Zurex president and CEO Carmine Durham said ZurexPrep is a new type of antimicrobial solution designed to prevent infections from forming after surgery. Durham said isopropyl alcohol does “a pretty good job by itself” in killing bacteria, but it dries quickly.

“Our proprietary formula actually supports the effect of the alcohol better,” he said. “We have a unique formula using small amounts of paraben and citrate.”

Paraben is commonly used as a preservative for cosmetics and pharmaceutical products. The citric acid works with the paraben to make the antimicrobial effect last longer, Durham said.

ZurexPrep is applied to the skin before surgery to decontaminate the area.

Durham said two studies of more than 1,300 people, in all, showed favorable results compared to the leading product on the market.

He said healthy volunteers were prepped for hypothetical surgery on the abdomen and groin area, “but you’re not cutting them.” Their skin was tested before they were prepped, and at three times after the application, up to six hours later.

Durham said infections at surgical sites are the most costly hospital-acquired infection, with the total price tag estimated at $3.5 billion to $10 billion a year, according to the Centers for Disease Control and Prevention.

Durham said he expects to submit a new drug application to the U.S. Food and Drug Administration “within weeks” and if all goes well, the product could be on the market after a 10-month review period.

The equity part of the new financing was led by existing investors. The State of Wisconsin Investment Board and Baird Capital continue to own a majority of the company’s preferred stock. A debt portion of the funding was led by Square 1 Bank, a division of Pacific Western Bank, which is based in Los Angeles.

The money will be used to help support Zurex’s new drug application, for sales and marketing of ZurexPrep, and for more product development.

Regulatory approval will “further validate our antimicrobial platform and open up numerous opportunities for a portfolio of new infection prevention and wound-care products,” Durham said.