CorMedix Launches Catheter Lock Product In Germany, Looks Ahead To U.S.

The company is shipping Neutrolin, a device containing an antimicrobial/antifungal agent and two anti-clotting agents, in Germany to “lock” catheters between dialysis sessions and prevent blood stream infections and clots. The New Jersey firm also is working with FDA to get the product approved in the U.S. as a specialty pharmaceutical.

It’s been a long time getting to market for CorMedix Inc.’s Neutrolin since the company licensed the product in 2008, but the product, which can prevent blood stream infections and clots in central venous catheter-using patients, is being shipped to dialysis centers in Germany now. CorMedix is also in discussions with FDA about a regulatory path forward for Neutrolin as a specialty pharmaceutical product in the U.S.

Bridgewater, N.J.-based CorMedix obtained worldwide development, manufacturing and marketing rights to Neutrolin from ND Partners LLC in February 2008 when the company was still privately owned [See Deal]. The product was approved as a device for the prevention of catheter-related bloodstream infections (CRBSI) and maintenance of catheter patency in hemodialysis patients from the European Union in July (Also see "New Products In Brief" - Medtech Insight, 15 Jul, 2013.).

In the U.S., the regulatory pathway has been less clear-cut. The product originally was considered a medical device in the U.S. but as Neutrolin was evaluated, the application was moved to the Center for Drug Evaluation and Research based on the fact that it contains an anti-infective solution, CorMedix CEO Randy Milby said in an interview.

“It was viewed as a medical device in the EU, and we didn’t have the resources to do a Phase III study at the time, so we went ahead to get the approval of a CE mark to launch in the EU as a beachhead, get some sales, collect some data and then go forward with a Phase III program.”

Following approval of the CE mark, CorMedix, which has a subsidiary in Germany that will manufacture the product, received approval from regional officials to begin sales in that country. As of Dec. 12, CorMedix began fulfilling orders for the product from German hemodialysis centers.

In November, CorMedix met with FDA to determine the path forward for getting Neutrolin approved as a specialty pharmaceutical product in the U.S. The company says it was encouraged by the dialogue with FDA but is not ready to comment specifically on the path forward for Neutrolin. Milby told “The Pink Sheet” DAILY that while he hopes Neutrolin can move right into a Phase III trial, it is possible FDA could request Phase IIb data first.

“We’ve got plenty of data – the ideal is that we could go directly into a Phase III study,” he said. “If that happens, we would enroll in the first quarter of next year and start the study in the second quarter. The study would go for one year, finish up around the second quarter of 2015 and then the analysis would take six months to one year.”

Being asked to do Phase IIb work first would “not be the end of the world,” the executive added. “If we went into a Phase IIb, the downside is that it takes a little bit longer and costs a little more money,” Milby said. “So, those patients would come into a Phase IIb and then we would roll them into a Phase III.”

Concentrated Markets A Bonus

Either way, the trial enrollment should proceed quickly, he said, because of how concentrated hemodialysis patients are in the U.S. A similar situation exists in Germany, which is why CorMedix is commercializing Neutrolin on its own in that country; the company plans to seek a marketing partner in other EU markets, as well as in the U.S.

“I’m open to partnerships everywhere,” Milby said. The company received interest from contract research organizations about co-funding development of Neutrolin in the U.S., although it has not signed any such agreement, he noted. “Since we’ve started to get some traction now, we had several companies approach us earlier and say this product would fit well into their armamentarium,” he said.

“We wanted to launch in Germany first as a standalone because that way we’re setting the pricing, we’re determining how to position the product with physicians,” Milby said. “The other consideration was that Germany is a high hemodialysis market and the CE mark was granted for use in dialysis.”

Both domestically and abroad, the marketing of Neutrolin is likely to involve detailing the product both to hemodialysis service providers such as DaVita Labs and Fresenius SE & Co. KGAA, as well as to individual dialysis centers. In Germany, smaller, private centers comprise about two-thirds of the hemodialysis market, Milby said.

Neutrolin is a combination product containing taurolidine, a broad-spectrum antimicrobial/antifungal agent with anti-clotting agents citrate and heparin. In trials, the product has reduced catheter-related infections by 94%. The company also hopes to market the product as an antithrombotic, but will need to collect data as part of the U.S. trials.

The company eventually plans to expand the label into other areas as well, including for use with catheters in oncology, intensive care and parenteral nutrition.

CorMedix went public in 2010, raising $11.4 million in an initial public offering that sold 1.9 million units, comprising two shares of common stock and a five-year warrant to buy one at a purchase price of $3.44. The unit price was $6.50 [See Deal]. Today, the company is trading at below $1. In October, the firm raised $3 million from existing institutional investors to continue advancing Neutrolin domestically and in Europe.