CorMedix Files IND Application for Neutrolin in the US

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Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount in advancing their pipelines.

Late last week, pharma company CorMedix Inc. (CRMD) announced that it has submitted an Investigational New Drug (IND) application to the FDA for Neutrolin. Although Neutrolin is approved in the EU, it is still under development in the U.S. CorMedix is developing Neutrolin for the prevention of catheter-related infections and thrombosis.

The IND includes a pivotal phase III protocol for Neutrolin in hemodialysis patients with a central venous catheter. We note that an IND goes into effect 30 days after the FDA receives the application, unless the regulatory body informs that the IND is subject to a clinical hold.

We remind investors that CorMedix started commercializing Neutrolin in Europe in the fourth quarter of 2013 for the prevention of catheter-related bloodstream infections (“CRBI”) and maintenance of catheter patency in patients suffering from hemodialysis. Recently, Neutrolin’s label was expanded in the EU. With the label expansion, Neutrolin can now be used in cancer patients receiving chemotheraphy, IV hydration and IV medications through central venous catheters. Patients receiving medications and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit and urgent care centers) are also covered by the label expansion. Moreover, CorMedix gained approval for an indication for use in total parenteral nutrition.

We expect investor focus to remain on pipeline updates pertaining to Neutrolin.

CorMedix is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Cambrex Corporation (CBM), Gilead Sciences Inc. (GILD) and Regado Biosciences, Inc. (RGDO). All three stocks carry a Zacks Rank #1 (Strong Buy).

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