CorMedix Inc.

CorMedix Inc. is a specialty pharmaceutical company that develops and seeks to commercialize products for the treatment of cardiac, renal and infectious diseases. Our goal is to treat human disease by reducing commonly associated renal, cardiovascular, metabolic and infectious complications. Our therapeutic candidates may be small molecules, biologics, chemical entities, devices and/or diagnostics (molecular/lab tests) that enable targeted therapy in these areas. Read more

 

View CorMedix Presentation here

Neutrolin®

Neutrolin

Neutrolin® is a catheter lock solution for the prevention of Catheter Related Bloodstream Infections (CRBI) and maintenance of catheter patency in Hemodialysis patients.

It is a broad-spectrum antimicrobial/antifungal and anticoagulant combination that is active against common microbes including antibiotic-resistant strains and in addition may prevent biofilm formation. We believe that using Neutrolin® as a catheter lock solution will significantly reduce the incidence of CRBIs, thus reducing the need for local and systemic antibiotics while prolonging catheter life. Learn more

News & Press

CorMedix Overview April 2015
CorMedix Abstract for Oral Presentations at NFK and VAS
CorMedix is proud to announce the acceptance of Abstracts for Oral Presentations at two prestigious global conferences:

-The National Kidney Foundation/NKF in Dallas, Texas presented by Dr. Christoph Wanner, Professor of Medicine and Head of the Renal Division at the University or Wurzburg, Germany

NKF Clinical Meeting 2015 - Poster Presentation_wa-2

NKF 2015 Presentation_Wanner

-The Vascular Access Society (VAS) in Barcelona, Spain presented by Dr. Markus Hollenbeck, Professor, Doctor of Medicine at Department of Nephrology and Intensive Care Medicine at Knappschaftskrankenhaus Bottrop, Germany

2015 Barcelona VAS Presentation Neutrolin

These oral presentations will highlight the data collected from our EU post approval surveillance studies or Neutrolin Use Monitoring Program (NUMP study)

CorMedix Inc. Provides Multiple Strategic Business Updates
-CorMedix Inc. Engages Evercore as Financial Advisor to Explore Strategic Alternatives to Maximize Shareholder Value-

-Elliott Management Provides Backstop Financing Commitment and Granted Right to Appoint Two Incremental Board Members-

-CorMedix Notified of Compliance with NYSE Listing Requirements-

- Expiration Date Extended for Certain Warrants-

-Will report Fourth Quarter 2014 Results and Host Conference Call on March 13 at 9 am EDT

 

BEDMINSTER, N.J., March 4, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced several strategic business updates.

CorMedix Engages Evercore as Financial Advisor to Explore Strategic Alternatives

CorMedix announced today that it has retained investment bank Evercore as financial advisor to explore strategic alternatives, in order to accelerate the global development of Neutrolin® Catheter Lock Solution and maximize shareholder value.

“Based on our ongoing belief in the value and clinical potential of Neutrolin® as an important product to address a significant medical need, the CorMedix Board and management has retained Evercore  to evaluate and identify strategic alternatives aimed to accelerate the product’s global development and commercialization,” said Randy Milby, CorMedix Chief Executive Officer. “We believe Evercore’s premier reputation, track record, and industry expertise will help us to maximize the value of Neutrolin® more efficiently”

Neutrolin® is a novel formulation of taurolidine, citrate and heparin 1000 u/ml that provides a combination preventative solution, decreases the triple threat of infection, thrombosis and biofilm to keep catheters operating safely and efficiently by optimizing catheter blood flow while minimizing infections and biofilm formation for oncology, hemodialysis, and intensive care patients.  Neutrolin® has CE mark approval for use in the European Union and was recently approved to enter a Phase 3 program in the United States.  The U.S. Food and Drug Administration (FDA) has designated Neutrolin®, as a Qualified Infectious Disease Product (QIDP), which provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity under Hatch-Waxman patent exclusivity.

 

 

 

CorMedix Extends Expiration Date for Certain Warrants; Elliott Management Provides Backstop Financing Commitment

CorMedix is extending to April 30, 2015 the expiration date for certain of its warrants for which the resale of the common stock underlying the warrants has not yet been registered. The extension is to allow the company time to register the resale of the underlying shares.  These warrants were issued to pre-IPO bridge investors in 2010. In addition, CorMedix announced that Elliott Management has extended to the company a financing commitment to serve as a back stop in the event these warrants are not exercised; CorMedix also agreed it will amend certain warrants held by Elliott and issue 200,000 additional warrants at an exercise price of $7.00.  Additionally, CorMedix granted Elliott the right to appoint two incremental board members.

CorMedix Notified of Compliance with NYSE MKT Listing Requirements

On Monday, March 2, 2015, the NYSE MKT notified CorMedix that the company has regained compliance with the NYSE MKT listing requirements since the Company as of February 26, 2015 qualified for the market capitalization exception in Section 1003(a) of the NYSE MKT Company Guide.

Fourth Quarter 2014 Financial Results Conference Call

CorMedix will host its fourth quarter 2014 financial results conference call on March 13, 2015 at 9 am EDT.  The conference call may be accessed by dialing 877- 407-8031 for domestic callers and 201-689-8031 for international callers. Please specify to the operator that you would like to join the "CorMedix Fourth Quarter 2014 Financial Results Call”.  All participants who dial in will need to give the operator the following information:

 

  • First and Last Name
  • Company Name: CorMedix

 

  • Replay Number (Toll Free): 1-877-660-6853 (International): 201-689-8031
  • Conference ID #: 13603512
  • Teleconference Replay Available Until: Mar 20, 2015 at 11:59 PM

 

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs, or ability to identify and enter into strategic transactions, should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: our ability to successfully identify, pursue and realize strategic opportunities; the cost, timing and results of  the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new  markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contacts:

 

Investors:

CorMedix Inc.

Randy Milby

rmilby@cormedix.com

(908) 517-9489

1430 Route 206, Suite 200,

Bedminster, NJ, 07921

 

Media:

Mike Beyer

Sam Brown Inc.

(312)-961-2502

mikebeyer@sambrown.com

 

Evercore

John Honts

(212) 857-3145

honts@evercore.com

 

CorMedix Institutes Program to Reduce Neutrolin® Cost of Goods; Reports on Strategic Review Process Managed by Evercore
BEDMINSTER, N.J., April 9, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a global biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced a significant new program aimed at enhancing long term market competitiveness by substantially reducing the cost of goods of Neutrolin® Catheter Lock Solution through a more efficient, custom synthesis of the active ingredient taurolidine.

CorMedix and [RC]2 Pharma Connect LLC, have reached an agreement  which will provide CorMedix with a cGMP API source able to produce needed volumes as CorMedix expands the sales of Neutrolin. [RC]2 assists companies like CorMedix in achieving more efficient ways of doing custom synthesis. [RC]2 has extensive scientific background and experience in process development and the manufacture of APIs (active pharmaceutical ingredients).

 

“This efficiency initiative, when fully implemented, is expected to provide us with sufficient cGMP API to meet the needs for potential expanded uses, including U.S. market entry, which would significantly reduce the cost of taurolidine, by up to 80 percent, thereby increasing the pharmaceutical manufacturing margins,” said Randy Milby, Chief Executive Officer of CorMedix. “This is a significant opportunity as CorMedix intends to expand the market potential of Neutrolin® in new geographic markets, including the U.S., and in additional therapeutic indications. We believe this represents a multi-billion dollar global market opportunity. In addition, we have several other volume related initiatives which are expected to reduce the total cost of goods by an incremental 15 to 30 percent once fully implemented.”

Neutrolin®, CorMedix’s novel formulation of taurolidine, citrate and heparin with 1000 u/ml provides a combination preventative catheter lock solution that decreases biofilm development thereby decreasing infection and thrombosis, to keep catheters operating both safely and efficiently by optimizing catheter blood flow. Catheter related bloodstream infections account for approximately 250,000 infections across all U.S. hospitals. The total annual cost in the U.S. of treating all catheter related episodes is approximately $5 billion according to internal estimates and a report by the Association for Professionals in Infection Control and Epidemiology (Guide to the elimination of catheter-related bloodstream infections). The Neutrolin Usage Monitoring Program that the company initiated has demonstrated that Neutrolin is effective in reducing catheter-related blood stream infections and thrombosis by greater than 90% in operational clinical settings in Germany.

 

Evercore Completes Preparatory Phase of Process

CorMedix today announced that Evercore has completed the preparatory phase of the previously announced strategic review process and will begin its outreach to potentially interested parties over the coming days. Evercore expects that the process will take several months to complete. CorMedix does not intend to provide further updates until the process has concluded. Evercore is a leading independent investment banking advisory firm that advises its clients on mergers, acquisitions, divestitures, restructurings, financings, public offerings, private placements and other strategic transactions and also provides institutional investors with high quality equity research, sales and trading execution. More information about Evercore can be found at www.evercore.com.

 

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. The company intends to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: CorMedix’s ability to achieve expected cost savings in its pharmaceutical manufacturing margins; the unpredictability of the size of the markets for, and market acceptance of, Neutrolin; CorMedix’s ability to identify and enter into strategic transactions; the cost, timing and results of  the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new  markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

 

Contact:

Investors:

CorMedix Inc.

Randy Milby

(908) 517-9489

 

Media:

Mike Beyer

Sam Brown Inc.

(312) 961-2502

mikebeyer@sambrown.com

CorMedix Clarifies Extension of Expiration Date for Publicly Traded Warrants
BEDMINSTER, N.J., March 9, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced that the extension to April 30, 2015 of the expiration date applies to all publicly traded warrants.

The holders of CorMedix warrants should note that the Company issued two tranches of warrants in 2010 with the same CUSIP number (No.21900C118).  The first tranche of warrants were purchased for cash in connection with the Company’s initial public offering of common stock in 2010, and may be exercised at the specified exercise price in exchange for registered, freely tradable shares of common stock issued pursuant to a currently effective registration statement.

 

The second tranche of warrants was also issued in 2010 to a select group of investors in exchange for debt issued prior to the Company’s initial public offering.  The holders of these warrants may exercise and receive in exchange shares of unregistered common stock.  The Company intends to file a registration statement for the resale of the shares issuable upon exercise of the second tranche of warrants as soon as practicable following the filing later this week of the Company’s Annual Report Form 10-K.

 

The exercise date for both tranches of warrants, inclusive of all publicly traded warrants, has been extended from March 24, 2015 to April 30, 2015.

 

Holders of CorMedix warrants should contact the Company’s transfer agent, VStock Transfer, LLC, at the number set forth below for assistance in determining whether their respective warrants were issued in the first or second tranche.  Prior to the availability of the resale registration statement described above, upon exercise holders will not receive shares of common stock free from restrictions on trading unless they can establish that their warrants were originally issued as part of the first tranche.

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, including with respect to the filing of the Company’s Form 10-K and registration statement, shoulCorMedix Clarifies Extension of Expiration Date for Publicly Traded Warrants

d be considered forward-looking. Risks applicable to CorMedix are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contact:

Investors:

CorMedix Inc.

Randy Milby

(908) 517-9489

 

Media:

Mike Beyer

Sam Brown Inc.

(312)-961-2502

mikebeyer@sambrown.com

 

VStock Transfer LLC

Allison Niccolls

(212) 828-8436

allison@vstocktransfer.com

CorMedix Announces Effectiveness of Registration Statements for Shares Underlying Publicly Traded Warrants
BEDMINSTER, N.J., March 9, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced that the extension to April 30, 2015 of the expiration date applies to all publicly traded warrants.

The holders of CorMedix warrants should note that the Company issued two tranches of warrants in 2010 with the same CUSIP number (No.21900C118).  The first tranche of warrants were purchased for cash in connection with the Company’s initial public offering of common stock in 2010, and may be exercised at the specified exercise price in exchange for registered, freely tradable shares of common stock issued pursuant to a currently effective registration statement.

 

The second tranche of warrants was also issued in 2010 to a select group of investors in exchange for debt issued prior to the Company’s initial public offering.  The holders of these warrants may exercise and receive in exchange shares of unregistered common stock.  The Company intends to file a registration statement for the resale of the shares issuable upon exercise of the second tranche of warrants as soon as practicable following the filing later this week of the Company’s Annual Report Form 10-K.

 

The exercise date for both tranches of warrants, inclusive of all publicly traded warrants, has been extended from March 24, 2015 to April 30, 2015.

 

Holders of CorMedix warrants should contact the Company’s transfer agent, VStock Transfer, LLC, at the number set forth below for assistance in determining whether their respective warrants were issued in the first or second tranche.  Prior to the availability of the resale registration statement described above, upon exercise holders will not receive shares of common stock free from restrictions on trading unless they can establish that their warrants were originally issued as part of the first tranche.

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, including with respect to the filing of the Company’s Form 10-K and registration statement, shoulCorMedix Clarifies Extension of Expiration Date for Publicly Traded Warrants

d be considered forward-looking. Risks applicable to CorMedix are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contact:

Investors:

CorMedix Inc.

Randy Milby

(908) 517-9489

 

Media:

Mike Beyer

Sam Brown Inc.

(312)-961-2502

mikebeyer@sambrown.com

 

VStock Transfer LLC

Allison Niccolls

(212) 828-8436

allison@vstocktransfer.com

CorMedix Clarifies Extension of Expiration Date for Publicly Traded Warrants
BEDMINSTER, N.J., March 9, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced that the extension to April 30, 2015 of the expiration date applies to all publicly traded warrants.

The holders of CorMedix warrants should note that the Company issued two tranches of warrants in 2010 with the same CUSIP number (No.21900C118).  The first tranche of warrants were purchased for cash in connection with the Company’s initial public offering of common stock in 2010, and may be exercised at the specified exercise price in exchange for registered, freely tradable shares of common stock issued pursuant to a currently effective registration statement.

 

The second tranche of warrants was also issued in 2010 to a select group of investors in exchange for debt issued prior to the Company’s initial public offering.  The holders of these warrants may exercise and receive in exchange shares of unregistered common stock.  The Company intends to file a registration statement for the resale of the shares issuable upon exercise of the second tranche of warrants as soon as practicable following the filing later this week of the Company’s Annual Report Form 10-K.

 

The exercise date for both tranches of warrants, inclusive of all publicly traded warrants, has been extended from March 24, 2015 to April 30, 2015.

 

Holders of CorMedix warrants should contact the Company’s transfer agent, VStock Transfer, LLC, at the number set forth below for assistance in determining whether their respective warrants were issued in the first or second tranche.  Prior to the availability of the resale registration statement described above, upon exercise holders will not receive shares of common stock free from restrictions on trading unless they can establish that their warrants were originally issued as part of the first tranche.

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, including with respect to the filing of the Company’s Form 10-K and registration statement, should be considered forward-looking. Risks applicable to CorMedix are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contact:

Investors:

CorMedix Inc.

Randy Milby

(908) 517-9489

 

Media:

Mike Beyer

Sam Brown Inc.

(312)-961-2502

mikebeyer@sambrown.com

 

VStock Transfer LLC

Allison Niccolls

(212) 828-8436

allison@vstocktransfer.com

 

CorMedix Inc. Receives Fast Track Designation for Neutrolin®
BRIDGEWATER, N.J., January 15, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a specialty pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) granted its request for Fast Track designation of its lead product candidate, Neutrolin® Catheter Lock Solution, pursuant to the Food and Drug Administration Safety and Innovation Act (FDASIA).  CorMedix's Neutrolin is a novel formulation of taurolidine, citrate and heparin with1000 u/ml that provides a combination preventative solution, decreases the triple threat of infection, thrombosis, and biofilm to keep catheter's operating safely and efficiently by optimizing catheter blood flow while minimizing infections and biofilm formation.

 

Fast Track designation is granted to drug products designed to treat a serious condition, for which clinical data has been generated and shown to potentially address an unmet medical need.  The Fast Track designation of Neutrolin provides CorMedix with the opportunity to meet with the FDA on a more frequent basis during the review process, and also ensures an expedited review of any marketing application.  Neutrolin has shown antimicrobial activity against many of the pathogens that are known to pose a serious threat to public health by causing blood-stream infections in ICU, oncology and hemodialysis patients. CorMedix intends to expand on the previously collected clinical data by conducting clinical trials with Neutrolin® Catheter Lock Solution in oncology, hemodialysis and intensive care unit patients, where catheter-related blood stream infections and clotting can be life-threatening.

“CorMedix is thrilled with this development.” said Randy Milby, CorMedix Chief Executive Officer. “We believe that this designation will be invaluable as we seek to rapidly develop Neutrolin® for the U.S. central venous catheter patients, and address a critical medical need in the oncology, intensive care communities.”

The request for Fast Track designation was followed by a December 2014 submission to the FDA requesting Neutrolin be designated a Qualified Infectious Disease Product (QIDP).  Designation of Neutrolin as a QIDP could secure incentives, such as the 5 year extension of marketing exclusivity, for pursuing marketing approval in the U.S.

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the cost, timing and results of  the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new  markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contact:

Randy Milby

(908) 517-9489

 

FDA Grants QIDP Designation to Neutrolin®, CorMedix Inc.’s Lead Product Candidate in the U.S.
CorMedix is Developing Neutrolin for the Prevention of Catheter Related Bloodstream Infections and Maintenance of Catheter Patency in Hemodialysis, Oncology and Intensive Care  

 

BRIDGEWATER, N.J., January 29, 2015 -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has designated the company’s lead product candidate, Neutrolin® Catheter Lock Solution, as a Qualified Infectious Disease Product (QIDP) for oncology, hemodialysis and intensive care unit patients, where catheter-related blood stream infections and clotting can be life-threatening.

The QIDP designation will make Neutrolin eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) program. These incentives include FDA priority review, eligibility for fast-track status and, if ultimately approved by the FDA, Neutrolin would be eligible for an additional five-year extension of Hatch-Waxman patent exclusivity.

Neutrolin is a novel formulation of taurolidine, citrate and heparin 1000 u/ml that provides a combination preventative solution, decreases the triple threat of infection, thrombosis and biofilm to keep catheters operating safely and efficiently by optimizing catheter blood flow while minimizing infections and biofilm formation.  Neutrolin has CE mark approval for use in the European Union and was recently approved to enter a planned Phase 3 program in the United States.

“CorMedix is delighted that the FDA has given Neutrolin a QIDP designation further affirming the importance of addressing the serious medical need related to catheter infections,” said Randy Milby, CorMedix Chief Executive Officer. “The QIDP designation, combined with the recently achieved Fast Track designation, will strongly support our goal to bring Neutrolin® to the U.S. market as fast as possible.”

In order to achieve QIDP designation, a drug product must be intended to treat serious or life-threatening infections, particularly those infections caused by “qualified pathogens,” as determined by the FDA.  These pathogens include Staphylococcus aureus, Streptococcus species and Pseudomonas species, among others.  Neutrolin has shown antimicrobial activity against many of these qualified pathogens, several of which are known to pose a serious threat to the public health by causing blood-stream infections in hemodialysis, oncology, and intensive care patients.

Neutrolin’s QIDP status follows its receipt of Fast Track designation, granted earlier this month.  Neutrolin’s Fast Track designation provides CorMedix with the opportunity to meet with the FDA on a more frequent basis during the review process, and provides eligibility for priority review of the marketing application.

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the cost, timing and results of  the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new  markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contact:

Investors:

Randy Milby

(908) 517-9489

 

Media:

Mike Beyer

Sam Brown Inc.

312-961-2502

mikebeyer@sambrown.com

CorMedix Receives Approval from FDA to Initiate a Clinical Trial for Neutrolin in the US

BRIDGEWATER, N.J., October 24, 2014 -- CorMedix Inc. (NYSE MKT: CRMD) is pleased to announce today that the United States Food and Drug Administration (FDA) has reviewed its Investigational New Drug application (IND) for Neutrolin® which was submitted September 24, 2014, and determined that the IND is not subject to a clinical hold, and that a pivotal clinical study can be initiated in the United States. CorMedix is a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases.

The IND includes a pivotal Phase 3 protocol for Neutrolin® in hemodialysis patients with a central venous catheter.  The Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program.

Randy Milby, CEO of CorMedix would like to thank all the members of the regulatory team, and the scientific advisors who helped prepare the IND, and wishes to express the company's appreciation to the FDA for its continued guidance in this important regulatory milestone for CorMedix.

Dr. Antony Pfaffle, Chief Scientific Officer at CorMedix stated, "The approval to initiate our pivotal clinical trial is an exciting development that we hope will lead to the availability of Neutrolin® for patients in the United States with central venous catheters. Neutrolin® is being developed to help prevent catheter-related infections and thrombosis. The active anti-infective ingredient in Neutrolin® is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi. Use of taurolidine has not been associated with the development of microbial resistance in humans.”

CorMedix is currently developing an additional Phase 3 protocol to support the use of Neutrolin® to prevent catheter related infections for oncology patients receiving total parenteral nutrition.

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the cost, timing and results of  the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new  markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; protecting the intellectual property developed by or licensed to CorMedix; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contact:

Randy Milby, Chief Executive Officer

Email: rmilby@cormedix.com

Tel: 908-517-9489

CorMedix Announces FDA IND Filing for Neutrolin® in United States
BRIDGEWATER, N.J., September 25, 2014 -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease,  is pleased to announce that an Investigational New Drug application (IND)  for Neutrolin® was submitted to the United States Food and Drug Administration (FDA) on Wednesday, September 24, 2014.

The IND includes a pivotal Phase 3 protocol for Neutrolin® in hemodialysis patients with a central venous catheter.  The Phase 3 clinical trial is designed as a multi-center, randomized, controlled study conducted in the U.S. and Europe.  Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin® Phase 3 program. An IND goes into effect 30 days after FDA receives the IND, unless FDA provides notification that the IND is subject to a clinical hold.

Dr. Antony Pfaffle, Chief Scientific Officer at CorMedix stated, "The filing of our IND is an important incremental step that we believe will lead to the availability of Neutrolin® for patients in the US with central venous catheters. Neutrolin® is being developed to help prevent catheter-related infections and thrombosis. The active anti-infective ingredient in Neutrolin® is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi. Use of taurolidine has not been associated with the development of microbial resistance in humans.”

Randy Milby, CEO of CorMedix would like to thank all the members of the regulatory team, and the scientific advisors who have helped prepare the IND, and wishes to express the company's appreciation to the FDA for its continued guidance in this important regulatory milestone for CorMedix.

Recently CorMedix reported the receipt of a broad label expansion in the entire European Union to include not only hemodialysis catheters, but also catheters used in chemotherapy, total parenteral nutrition and critical care settings. CorMedix is proud to continue to support Neutrolin® development and hopes to gain FDA approval to introduce the product in the US to prevent catheter-related infections and thrombosis.

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the cost, timing and results of  the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new  markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Neutrolin Label Expansion Approved for the European Union
BRIDGEWATER, N.J., September 19, 2014 -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal and infectious disease, today is pleased to announce that TUV-SUD and The Medicinal Evaluation Board of the Netherlands (MEB) has granted its request for a label expansion for Neutrolin, its catheter lock solution.  Neutrolin was initially approved in July 2013 for use in the prevention of catheter-related bloodstream infections (CRBI) and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access.

The label expansion includes approval for additional indications for use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also includes patients receiving medication 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). An indication for use in total parenteral nutrition was also approved.

The company believes that the label expansion will enable additional critically ill patients to benefit from the expanded use of Neutrolin to prevent infection and thrombosis. The active anti-infective ingredient in Neutrolin is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi. Despite a long history of clinical use, development of resistance has not been observed.

Randy Milby, Chief Executive Officer and Dr. Antony Pfaffle, Chief Scientific Officer of CorMedix, stated, "We are very pleased with the label expansion and the extended ability to treat patients with urgent medical needs. We thank the regulatory authorities and our regulatory advisors for their cooperation in achieving this significant milestone.”

 

About CorMedix Inc.

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients including neonates, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications.  Please see the company's website at www.cormedix.com for additional information. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the cost, timing and results of  the planned Phase 3 trial for Neutrolin in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin® in countries other than Europe; the risks associated with the launch of Neutrolin® in new  markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Contact:

Randy Milby

(908) 517-9489

Phase III Clinical Trial

October, 2014, CorMedix Inc. announced that the United States Food and Drug Administration (FDA) had reviewed its Investigational New Drug application (IND) for Neutrolin® which was submitted September 24, 2014, and determined that the IND is not subject to a clinical hold, and that a pivotal clinical study can be initiated in the United States. 

The IND includes a pivotal Phase 3 protocol for Neutrolin® in hemodialysis patients with a central venous catheter.  The Phase 3 clinical trVials and Syringeial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program. Read more