While Cormedix Inc. fights for patent rights in Germany and shops for a partner that could help pay for trials with the antimicrobial catheter-lock solution Neutrolin, guidance from U.S. gatekeepers regarding the second pivotal, phase III trial with the product spiced shares of the Bedminster, N.J.-based firm (AMEX:CRMD), which closed Wednesday at $5.09, up 33 cents, having traded as high as $5.75.

The company did not disclose the specifics of the guidance and CEO Randy Milby could not be reached because he was traveling. Cormedix said in a statement that the comments from the FDA "should enhance the proposed study," which is intended to test Neutrolin in oncology patients who require total parenteral nutrition and would support the filing of a new drug application.

Neutrolin combines citrate, heparin and taurolidine, the last being an amino acid derivative which works as an antibacterial and shows broad antibacterial action against gram-positive and gram-negative bacteria, mycobacteria, and clinically relevant fungi. Cormedix's three-part product is engineered to reduce threats of infection, thrombosis and biofilm formation so that catheters work safely. Without Neutrolin, the company said, biofilm with microbial colonization begins to develop within 24 hours after the catheter is placed.

The FDA has already reviewed the pivotal phase III trial that would assess Neutrolin's efficacy in hemodialysis patients, and the company is trying, with help from the investment bank Evercore, to raise money or find a partner that would help finance the experiment. Milby told investors during a conference call on earnings in May that the company was "not going to provide additional details on the Evercore process, but I can tell you, they had a target list of companies, and as I mentioned on the last-quarter call, they [have] reached out to a number of these companies and it's an ongoing process."

Stonegate Capital Markets analyst Dan Trang pointed out in a research report last month that "many of the companies Evercore has relationships [with] are beyond the U.S., so there is a possibility of increasing Neutrolin's international footprint. We believe that leveraging Evercore's relationships with other third parties opens possibilities for Neutrolin domestically and abroad that the company could not undertake by itself."

Neutrolin, which has won qualified infectious disease product and fast track designations from the FDA, was first launched a year and a half ago in Germany as a class III drug-device combination for use during hemodialysis with a tunneled central vein catheter. A label expansion, granted in September 2014, includes approval for oncology patients getting chemotherapy, intravenous (IV) hydration, and IV medications via central venous catheters. The expansion also includes patients given drugs and IV fluids by way of the same method in intensive or critical care units. An indication for use in total parenteral nutrition was approved, too. The FDA first planned to review Neutrolin as a device but in 2011 said it would be evaluated as a drug.

In Mannheim, Germany district court, Cormedix has a patent infringement and utility model claim against the Bavarian firm Tauropharm GmbH kicking around in the district court. Roth Capital Partners analyst Scott Henry wrote in a research report that the judicial body most recently "appeared to agree with Cormedix's position, but it has sent the case back to another court to determine patent validity. The net is that a final court decision on injunction likely remains at least a year away." The firm has another pending action against Tauropharm in the district court in Cologne, Germany, regarding violation of German unfair competition laws. A hearing is scheduled for early next month.

Cormedix is asking for injunctive relief and monetary damages based on its argument that Tauropharm infringes the European patent by manufacturing, selling and distributing in Germany its 100 unit and 500 unit heparin products that compete with Neutrolin. Milby pointed out during the May conference call that since Tauropharm is privately held, "we don't have access to their sales data [but] we do see them in the marketplace, obviously, and it has had an impact on our uptake."

Supply of taurolidine for Neutrolin was solidified through a deal with Navinta LLC, of Ewing, N.J., which agreed to sell the ingredient exclusively to Cormedix for the prevention and treatment of human infection and dialysis as long as the company meets the minimum purchase rates.

Cormedix caught much of the biotech industry by surprise in 2010 when the specialty pharma firm, then relatively obscure, priced a $12.5 million initial public offering. (See BioWorld Today, March 29, 2010.)