Douglas Landy's Instablog Doug Landy is a former sell-side associate, pharmacy director, and pharmacist, with experience that includes investing and stock market analysis since 1995. Doug started his career in healthcare delivering prescriptions for a family owned pharmacy, has 10 years experience in hospital pharmacy, and most recently worked as a pharmacy director for a publicly traded company focusing on the long-term care pharmacy market. Doug covered the generic, drug delivery and bio-pharmaceutical sector (New York, New York) from 2005-2007. His current focus is the micro-cap pharmaceutical/healthcare sector. Doug holds a BS in Pharmacy from the University of Pittsburgh (1999), and MBA from Carnegie Mellon University (2004). Doug is also ...More very interested in physical fitness, rooting for the Pittsburgh Steelers, Pitt Panthers, and traveling to new destinations. Douglas Landy http://seekingalpha.com Another 'Buy Rating' for the 'Cor'! http://seekingalpha.com/instablog/651349-douglas-landy/81917-another-buy-rating-for-the-cor?source=feed 81917
CorMedix Inc. (AMEX:CRMD), a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease, today had a NEW 'BUY' recommendation placed on the stock by National Securities research analyst Jason Kolbert, who states:

"We see the Company as ideally positioned at the cardio-renal crossroads; that is, treating kidney diseases and rducing the commonly associated cardiovascular and metabolic complications..."  

This is the second analyst to initiate coverage on the name in recent weeks.

CorMedix product candidates include a risk-mitigated clinical development profile, target significant niche markets, and have a relatively low cost of development through potential commercialization. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic conditions.

CorMedix has two Products entering late stage clinical development
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD). The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012.
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD). Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug that was expected that began a Phase 2 study on 6/25/10 with interim data anticipated in 4Q10.

CorMedix was added to Russell Microcap® Index on 6/29/10.

CorMedix is gaining attention!! And for good reason.






  




Disclosure: No Position]]> Thu, 15 Jul 2010 11:56:20 -0400
CorMedix Inc. (AMEX:CRMD), a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease, today had a NEW 'BUY' recommendation placed on the stock by National Securities research analyst Jason Kolbert, who states:

"We see the Company as ideally positioned at the cardio-renal crossroads; that is, treating kidney diseases and rducing the commonly associated cardiovascular and metabolic complications..."  

This is the second analyst to initiate coverage on the name in recent weeks.

CorMedix product candidates include a risk-mitigated clinical development profile, target significant niche markets, and have a relatively low cost of development through potential commercialization. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic conditions.

CorMedix has two Products entering late stage clinical development
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD). The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012.
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD). Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug that was expected that began a Phase 2 study on 6/25/10 with interim data anticipated in 4Q10.

CorMedix was added to Russell Microcap® Index on 6/29/10.

CorMedix is gaining attention!! And for good reason.






  




Disclosure: No Position]]> crmd Getting to the 'Cor' of Cardiorenal Disease: Cormedix (CRMD) http://seekingalpha.com/instablog/651349-douglas-landy/78659-getting-to-the-cor-of-cardiorenal-disease-cormedix-crmd?source=feed 78659 CorMedix Inc. (AMEX:CRMD) is a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease. These product candidates include a risk-mitigated clinical development profile, target significant niche markets, and have a relatively low cost of development through potential commercialization. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic conditions.
CorMedix hast two Products entering late stage clinical development
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD)
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD)
 
The main focus for Cormedix investors initially will be on lead product candidate Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution is anticipated to be ready for IDE submission to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end. The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012. Neutrolin combines the anti-coagulants (citrate and heparin) and the antimicrobial (taurolidine) in a liquid formulation to fill or “lock” central venous catheters (CVC). The initial indication for Neutrolin will be in HD patients with CVCs. However, there are several other potential uses including intensive care, total parenteral nutrition (TPN) and CVCs for delivery of chemotherapy agents.
The Market Opportunity for Neutrolin is anything but small for those of you who have never worked in an acute care (hospital setting): 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year. CVCs are subject to clotting and are associated with catheter-related bloodstream infection (CRBI). There are 160,000 CRBI episodes in the U.S. alone, 6,000 die annually, and the cost to US healthcare system is (roughly) an astounding $1 billion. The current standard of care (heparin) does not prevent CRBI.

 
 
 
Neutrolin for Prevention of CRBI will be supplied via catheter lock solution for the prevention of CRBI and maintenance of catheter function in HD patients. The solution will contain Taurolidine, a broad-spectrum antimicrobial, targeted to prevent infection and formation of biofilm. Unlike other antibiotics, there has been no observed bacterial resistance to Taurolidine – unlike antibiotics (>14,000 patients exposed), no systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin. The lock solution also contains citrate and heparin as anti-coagulants to prevent thrombus formation and clotting (which is per normal use in the hospital). It is safe and well tolerated. No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients
 
Pivotal Study Plan
 
As mentioned above, Cormedix anticipates starting enrollment H1 2011 for Neutrolin’s prospective, multicenter, double blind, randomized, active comparator study. The study will have approximately 400 patients; study anticipated to be 15 months in duration with the following primary endpoints:
 
1. Freedom from catheter related bloodstream infection – time to event
 
2. Duration of time that adequate catheter function is maintained
 
 
Commercialization Plan
 
 Initial U.S. launch by CorMedix in HD indication
 
o Intend to establish Neutrolin as standard of care for HD patients with CVC, expect inclusion on renal guidelines and dialysis providers policy & procedure protocols
 
Quality of care endorsements for improvement in performance criteria in dialysis networks
 
 Reimbursement
 
o Apply for a J code
 
o Inclusion in bundle for dialysis as a separately billable drug
 
 Apply for CE mark in EU as soon as quality systems in place
 
 Apply for additional indications for CVCs and PICC lines in non-HD indications
 
IP Overview
 
 Six (6) issued patents – protection through 2019-2025
 
 
Expected Clinical and Regulatory Milestones for CorMedix
 
1.       Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution, should receive IDE approval to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end. The pivotal U.S. study is slated to begin 1H11 with interim data anticipated early in 2012.
 
In addition to Neutrolin, Cormedix has one other ‘near-term’ opportunity in Deferiprone:
 
2. Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug with a Phase 2 study expected to begin 2Q10 with interim data anticipated in 4Q10. This trial will likely be followed by a larger, pivotal Phase 3 study under a Special Protocol Assessment (SPA) with the FDA. Deferiprone is being developed for the treatment of contrast induced nephropathy (kidney damage associated with medical imaging procedures).
 
3. CRMD002 – the development and commercialization of a readily available biomarker test for urine labile iron will be supportive to the development and subsequent potential commercialization of Deferiprone (CRMD001).
 
4. CRMD004 is a novel thixotropic (changes from semi-solid state to free-flowing liquid under pressure generated upon insertion / withdrawal from a catheter) gel formulation in pre-clinical development. CRMD004 could be combined with taurolidine, other antimicrobials, anticoagulants or enzymes for use as a catheter lock solution with the potential to extend the benefits of Neutrolin.


Disclosure: No Position]]> Sun, 27 Jun 2010 20:14:32 -0400 CorMedix Inc. (AMEX:CRMD) is a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease. These product candidates include a risk-mitigated clinical development profile, target significant niche markets, and have a relatively low cost of development through potential commercialization. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic conditions.
CorMedix hast two Products entering late stage clinical development
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD)
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD)
 
The main focus for Cormedix investors initially will be on lead product candidate Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution is anticipated to be ready for IDE submission to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end. The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012. Neutrolin combines the anti-coagulants (citrate and heparin) and the antimicrobial (taurolidine) in a liquid formulation to fill or “lock” central venous catheters (CVC). The initial indication for Neutrolin will be in HD patients with CVCs. However, there are several other potential uses including intensive care, total parenteral nutrition (TPN) and CVCs for delivery of chemotherapy agents.
The Market Opportunity for Neutrolin is anything but small for those of you who have never worked in an acute care (hospital setting): 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year. CVCs are subject to clotting and are associated with catheter-related bloodstream infection (CRBI). There are 160,000 CRBI episodes in the U.S. alone, 6,000 die annually, and the cost to US healthcare system is (roughly) an astounding $1 billion. The current standard of care (heparin) does not prevent CRBI.

 
 
 
Neutrolin for Prevention of CRBI will be supplied via catheter lock solution for the prevention of CRBI and maintenance of catheter function in HD patients. The solution will contain Taurolidine, a broad-spectrum antimicrobial, targeted to prevent infection and formation of biofilm. Unlike other antibiotics, there has been no observed bacterial resistance to Taurolidine – unlike antibiotics (>14,000 patients exposed), no systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin. The lock solution also contains citrate and heparin as anti-coagulants to prevent thrombus formation and clotting (which is per normal use in the hospital). It is safe and well tolerated. No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients
 
Pivotal Study Plan
 
As mentioned above, Cormedix anticipates starting enrollment H1 2011 for Neutrolin’s prospective, multicenter, double blind, randomized, active comparator study. The study will have approximately 400 patients; study anticipated to be 15 months in duration with the following primary endpoints:
 
1. Freedom from catheter related bloodstream infection – time to event
 
2. Duration of time that adequate catheter function is maintained
 
 
Commercialization Plan
 
 Initial U.S. launch by CorMedix in HD indication
 
o Intend to establish Neutrolin as standard of care for HD patients with CVC, expect inclusion on renal guidelines and dialysis providers policy & procedure protocols
 
Quality of care endorsements for improvement in performance criteria in dialysis networks
 
 Reimbursement
 
o Apply for a J code
 
o Inclusion in bundle for dialysis as a separately billable drug
 
 Apply for CE mark in EU as soon as quality systems in place
 
 Apply for additional indications for CVCs and PICC lines in non-HD indications
 
IP Overview
 
 Six (6) issued patents – protection through 2019-2025
 
 
Expected Clinical and Regulatory Milestones for CorMedix
 
1.       Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution, should receive IDE approval to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end. The pivotal U.S. study is slated to begin 1H11 with interim data anticipated early in 2012.
 
In addition to Neutrolin, Cormedix has one other ‘near-term’ opportunity in Deferiprone:
 
2. Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug with a Phase 2 study expected to begin 2Q10 with interim data anticipated in 4Q10. This trial will likely be followed by a larger, pivotal Phase 3 study under a Special Protocol Assessment (SPA) with the FDA. Deferiprone is being developed for the treatment of contrast induced nephropathy (kidney damage associated with medical imaging procedures).
 
3. CRMD002 – the development and commercialization of a readily available biomarker test for urine labile iron will be supportive to the development and subsequent potential commercialization of Deferiprone (CRMD001).
 
4. CRMD004 is a novel thixotropic (changes from semi-solid state to free-flowing liquid under pressure generated upon insertion / withdrawal from a catheter) gel formulation in pre-clinical development. CRMD004 could be combined with taurolidine, other antimicrobials, anticoagulants or enzymes for use as a catheter lock solution with the potential to extend the benefits of Neutrolin.


Disclosure: No Position]]> crmd Unilife: Preventing the Pain and Peril of Needle Sticks http://seekingalpha.com/instablog/651349-douglas-landy/78448-unilife-preventing-the-pain-and-peril-of-needle-sticks?source=feed 78448 Unilife (UNIS: NASDAQ) develops and supplies innovative safety medical devices for pharmaceutical and healthcare markets that mandate the use of safety needles and sharps. Unilife is progressively launching its patented portfolio of prefilled and clinical syringes under two brands: 1. Unifill ™, a glass-barreled, prefilled safety syringe; and 2. Unitract ™, a line of plastic barreled, clinical safety syringes. The uniqueness of Unilife’s products lies in the fact that the needle retraction is both automatic and operator controlled within a fully integrated syringe—a combination of safety features that Unilife does not believe is available in any other technology marketed today.
The Company’s syringes may virtually eliminate the risk of acquiring blood borne infections, such HIV or Hep C, via needlestick injuries or blood spatter. Sanofi-Aventis SA (SNY), thought to be the world’s largest purchaser of prefilled syringes, is funding up to $28.5MM (pre-sales) for industrialization and exclusive right to buy the Unifill ™ Syringe in therapeutic areas such as vaccines and antithrombotics. (Unilife holds ISO 13485 certifications with FDA registered manufacturing facilities located in Pennsylvania). Unilife aims to establish agreements with other pharma companies in areas not reserved for Sanofi-Aventis.
Unilife (UNIS) began trading on the NASDAQ on February 16, 2010.
Achieved Milestones for Unilife:
·         April 2009: Completed transition of Unilife headquarters to the U.S.
·         June 2009: Entered into an Industrialization Agreement with Sanofi-Aventis
·         August 2009: Began production of the Unitract ™ 1ml Syringes
·         September 2009: Proposed a redomiciliation to the U.S. with trading on the NASDAQ
·         October 2009: Received an $5.2 million package from the Pennsylvania government
·         November 2009: Filed an Information Memorandum (Australian Securities and Investments Commission [ASIC] and Form 10 (SEC) documents; Completed a $53.6MM capital raise; Appointed Mikron Group as an assembly line partner for Unifll ™ production; Filed patents for a new pipeline syringe, the Unifill ™ Select
·         December 2009: Signed agreements for the construction of new global headquarters and commercial production facility in York, Pennsylvania
·         January 2010: Completed final stages of redomiciliation in the U.S.
·         February 2010: Form 10 filed with the SEC declared effective; Commenced trading on NASDAQ stock exchange under ticker “UNIS”; Donated its first shipment of Unitract ™ 1ml syringes to Doctors Without Borders in Haiti
·         March 2010: Signed an Exclusivity List with Sanofi-Aventis for the Unifill ™ syringe incorporating therapeutic areas including antithrombotics and vaccines; Entered into an exclusive five-year contract with Stason for the distribution of the Unitract ™ 1ml Syringe within Japan, Taiwan, and China, which included the placement of an order for one million units during the first year and additional one million units for subsequent years of the contract.
·         April 2010: Received FDA clearance for U.S. manufactured units of the Unitract ™ 1ml Insulin Syringe and subsequent change to four-shift, 24/7 operations at Lewisberry facility.
Potential Milestones for Unilife
  • Unilife expects to complete construction of the York, Pennsylvania, facility in late 2010
  • Unilife aims to employ approximately 200 individuals by the end of 2010
  • The industrialization program with Sanofi-Aventis is on track to be completed one year ahead of schedule (late 2010). Supply of the Unifill ™ Syringe to Sanofi-Aventis could begin upon the completion of the industrialization program, with a high-volume automated assembly system expected to be established by the end of 2011.
  • During 2010, Unilife expects to begin to formalize additional relationships with a number of other pharmaceutical companies that with to use the Unifill ™ Syringe in areas not designated as exclusive to Sanofi-Aventis
  • Unilife intends to begin full commercial supply of its Unitract ™ 1ml Syringe during the first half of 2010 and to secure further distribution agreements for this line of syringes in the U.S. and overseas.


Disclosure: No Position]]> Fri, 25 Jun 2010 11:38:57 -0400 Unilife (UNIS: NASDAQ) develops and supplies innovative safety medical devices for pharmaceutical and healthcare markets that mandate the use of safety needles and sharps. Unilife is progressively launching its patented portfolio of prefilled and clinical syringes under two brands: 1. Unifill ™, a glass-barreled, prefilled safety syringe; and 2. Unitract ™, a line of plastic barreled, clinical safety syringes. The uniqueness of Unilife’s products lies in the fact that the needle retraction is both automatic and operator controlled within a fully integrated syringe—a combination of safety features that Unilife does not believe is available in any other technology marketed today.
The Company’s syringes may virtually eliminate the risk of acquiring blood borne infections, such HIV or Hep C, via needlestick injuries or blood spatter. Sanofi-Aventis SA (SNY), thought to be the world’s largest purchaser of prefilled syringes, is funding up to $28.5MM (pre-sales) for industrialization and exclusive right to buy the Unifill ™ Syringe in therapeutic areas such as vaccines and antithrombotics. (Unilife holds ISO 13485 certifications with FDA registered manufacturing facilities located in Pennsylvania). Unilife aims to establish agreements with other pharma companies in areas not reserved for Sanofi-Aventis.
Unilife (UNIS) began trading on the NASDAQ on February 16, 2010.
Achieved Milestones for Unilife:
·         April 2009: Completed transition of Unilife headquarters to the U.S.
·         June 2009: Entered into an Industrialization Agreement with Sanofi-Aventis
·         August 2009: Began production of the Unitract ™ 1ml Syringes
·         September 2009: Proposed a redomiciliation to the U.S. with trading on the NASDAQ
·         October 2009: Received an $5.2 million package from the Pennsylvania government
·         November 2009: Filed an Information Memorandum (Australian Securities and Investments Commission [ASIC] and Form 10 (SEC) documents; Completed a $53.6MM capital raise; Appointed Mikron Group as an assembly line partner for Unifll ™ production; Filed patents for a new pipeline syringe, the Unifill ™ Select
·         December 2009: Signed agreements for the construction of new global headquarters and commercial production facility in York, Pennsylvania
·         January 2010: Completed final stages of redomiciliation in the U.S.
·         February 2010: Form 10 filed with the SEC declared effective; Commenced trading on NASDAQ stock exchange under ticker “UNIS”; Donated its first shipment of Unitract ™ 1ml syringes to Doctors Without Borders in Haiti
·         March 2010: Signed an Exclusivity List with Sanofi-Aventis for the Unifill ™ syringe incorporating therapeutic areas including antithrombotics and vaccines; Entered into an exclusive five-year contract with Stason for the distribution of the Unitract ™ 1ml Syringe within Japan, Taiwan, and China, which included the placement of an order for one million units during the first year and additional one million units for subsequent years of the contract.
·         April 2010: Received FDA clearance for U.S. manufactured units of the Unitract ™ 1ml Insulin Syringe and subsequent change to four-shift, 24/7 operations at Lewisberry facility.
Potential Milestones for Unilife
  • Unilife expects to complete construction of the York, Pennsylvania, facility in late 2010
  • Unilife aims to employ approximately 200 individuals by the end of 2010
  • The industrialization program with Sanofi-Aventis is on track to be completed one year ahead of schedule (late 2010). Supply of the Unifill ™ Syringe to Sanofi-Aventis could begin upon the completion of the industrialization program, with a high-volume automated assembly system expected to be established by the end of 2011.
  • During 2010, Unilife expects to begin to formalize additional relationships with a number of other pharmaceutical companies that with to use the Unifill ™ Syringe in areas not designated as exclusive to Sanofi-Aventis
  • Unilife intends to begin full commercial supply of its Unitract ™ 1ml Syringe during the first half of 2010 and to secure further distribution agreements for this line of syringes in the U.S. and overseas.


Disclosure: No Position]]> Nasdaq CorMedix Phase II Trial Underway http://seekingalpha.com/instablog/651349-douglas-landy/78400-cormedix-phase-ii-trial-underway?source=feed 78400
CorMedix Inc. (AMEX:CRMD), a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease, today announced dosing of the first patient with CRMD-001 (a proprietary formulation of deferiprone)in a randomized, double-blind, placebo-controlled clinical trial.

This Phase II proof-of-concept study is for the prevention of contrast-induced acute kidney injury in approximately 60 high-risk patients with chronic kidney disease (CKD) and additional risk factors, who are undergoing coronary angiography with the intent of adjunctive percutaneous coronary intervention (PCI).
 
 
Recall that CorMedix product candidates include a risk-mitigated clinical development profile, target significant niche markets, and have a relatively low cost of development through potential commercialization. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic conditions.

CorMedix has two Products entering late stage clinical development
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD)
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD). Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug that was expected to begin today’s announced Phase II study in 2Q10 interim data anticipated in 4Q10.

Today’s announced Phase II study is currently being conducted at two study centers in the United States: Providenc Hospital and Medical Center in Southfield, MI and Northern Michigan Regional Hospital in Petoskey, MI.

The primary objective of this trial is to assess the impact of the oral iron chelator, CRMD-001 on sensitive biomarkers of contrast-induced acute kidney injury in this high-risk patient population with CKD. In addition, the study will assess the safety and tolerability of CRMD-001 for shortterm use. Patients will be randomized to receive either CRMD-001 or placebo, and they will be dosed orally for 8 days, starting immediately prior to coronary angiography. Biomarker, safety and clinical endpoints will be assessed through 90 days.

This trial will likely be followed by a larger, pivotal Phase 3 study under a Special Protocol Assessment (SPA) with the FDA. Deferiprone is being developed for the treatment of contrast induced nephropathy (kidney damage associated with medical imaging procedures).

“There may be a significant opportunity for CRMD-001 to fulfill the unmet medical need of preventing contrast-induced nephropathy in high-risk patients, and we look forward to generating compelling clinical data,” stated Peter A. McCullough, MD, MPH, Principal Investigator of the study.

Of course, the main focus for Cormedix investors remains lead product candidate Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution is anticipated to be ready for IDE submission to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end.

The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012. Neutrolin combines the anti-coagulants (citrate and heparin) and the antimicrobial (taurolidine) in a liquid formulation to fill or “lock” central venous catheters (CVC). The initial indication for Neutrolin will be in HD patients with CVCs. However, there are several other potential uses including intensive care, total parenteral nutrition (TPN) and CVCs for delivery of chemotherapy agents.
The Market Opportunity for Neutrolin is anything but small for those of you who have never worked in an acute care (hospital setting): 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year. CVCs are subject to clotting and are associated with catheter-related bloodstream infection (CRBI). There are 160,000 CRBI episodes in the U.S. alone, 6,000 die annually, and the cost to US healthcare system is (roughly) an astounding $1 billion. The current standard of care (heparin) does not prevent CRBI.
Neutrolin for Prevention of CRBI will be supplied via catheter lock solution for the prevention of CRBI and maintenance of catheter function in HD patients. The solution will contain Taurolidine, a broad-spectrum antimicrobial, targeted to prevent infection and formation of biofilm. Unlike other antibiotics, there has been no observed bacterial resistance to Taurolidine – unlike antibiotics (>14,000 patients exposed), no systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin. The lock solution also contains citrate and heparin as anti-coagulants to prevent thrombus formation and clotting (which is per normal use in the hospital). It is safe and well tolerated. No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients




Disclosure: No Positions]]> Fri, 25 Jun 2010 08:51:30 -0400
CorMedix Inc. (AMEX:CRMD), a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease, today announced dosing of the first patient with CRMD-001 (a proprietary formulation of deferiprone)in a randomized, double-blind, placebo-controlled clinical trial.

This Phase II proof-of-concept study is for the prevention of contrast-induced acute kidney injury in approximately 60 high-risk patients with chronic kidney disease (CKD) and additional risk factors, who are undergoing coronary angiography with the intent of adjunctive percutaneous coronary intervention (PCI).
 
 
Recall that CorMedix product candidates include a risk-mitigated clinical development profile, target significant niche markets, and have a relatively low cost of development through potential commercialization. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic conditions.

CorMedix has two Products entering late stage clinical development
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD)
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD). Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug that was expected to begin today’s announced Phase II study in 2Q10 interim data anticipated in 4Q10.

Today’s announced Phase II study is currently being conducted at two study centers in the United States: Providenc Hospital and Medical Center in Southfield, MI and Northern Michigan Regional Hospital in Petoskey, MI.

The primary objective of this trial is to assess the impact of the oral iron chelator, CRMD-001 on sensitive biomarkers of contrast-induced acute kidney injury in this high-risk patient population with CKD. In addition, the study will assess the safety and tolerability of CRMD-001 for shortterm use. Patients will be randomized to receive either CRMD-001 or placebo, and they will be dosed orally for 8 days, starting immediately prior to coronary angiography. Biomarker, safety and clinical endpoints will be assessed through 90 days.

This trial will likely be followed by a larger, pivotal Phase 3 study under a Special Protocol Assessment (SPA) with the FDA. Deferiprone is being developed for the treatment of contrast induced nephropathy (kidney damage associated with medical imaging procedures).

“There may be a significant opportunity for CRMD-001 to fulfill the unmet medical need of preventing contrast-induced nephropathy in high-risk patients, and we look forward to generating compelling clinical data,” stated Peter A. McCullough, MD, MPH, Principal Investigator of the study.

Of course, the main focus for Cormedix investors remains lead product candidate Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution is anticipated to be ready for IDE submission to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end.

The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012. Neutrolin combines the anti-coagulants (citrate and heparin) and the antimicrobial (taurolidine) in a liquid formulation to fill or “lock” central venous catheters (CVC). The initial indication for Neutrolin will be in HD patients with CVCs. However, there are several other potential uses including intensive care, total parenteral nutrition (TPN) and CVCs for delivery of chemotherapy agents.
The Market Opportunity for Neutrolin is anything but small for those of you who have never worked in an acute care (hospital setting): 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year. CVCs are subject to clotting and are associated with catheter-related bloodstream infection (CRBI). There are 160,000 CRBI episodes in the U.S. alone, 6,000 die annually, and the cost to US healthcare system is (roughly) an astounding $1 billion. The current standard of care (heparin) does not prevent CRBI.
Neutrolin for Prevention of CRBI will be supplied via catheter lock solution for the prevention of CRBI and maintenance of catheter function in HD patients. The solution will contain Taurolidine, a broad-spectrum antimicrobial, targeted to prevent infection and formation of biofilm. Unlike other antibiotics, there has been no observed bacterial resistance to Taurolidine – unlike antibiotics (>14,000 patients exposed), no systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin. The lock solution also contains citrate and heparin as anti-coagulants to prevent thrombus formation and clotting (which is per normal use in the hospital). It is safe and well tolerated. No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients




Disclosure: No Positions]]> crmd Buy Rating for the 'COR'; Cormedix Gaining Attention: http://seekingalpha.com/instablog/651349-douglas-landy/74654-buy-rating-for-the-cor-cormedix-gaining-attention?source=feed 74654 Greetings Everyone!

Buy Rating Initiated at Maxim!

In a nice follow up to my recent positive blog on CorMedix Inc (CRMD), Maxim Group, LLC has initiated coverage of the company with a BUY rating and 12 month price target of $5.00 ($2.60 current price).

The buy-rating and increased coverage should bring more investors into the name, over the next several months ,as clinical trials roll on.

Cormedix offers two late stage drug opportunities with positive early stage data, relatively low clinical risk, in a ddition to a share count and market cap value that will allow for positive pps momentum.

Keep an eye out for CRMD.

 

Initiation                                                                           Buy

CorMedix Inc.    

(CRMD – AMEX – $2.60)

 

Mid- and late-clinical-stage pipeline with encouraging data, unmet medical need, and substantial market potential; Initiating coverage with a Buy rating and $5 price target

 

We are initiating coverage of CorMedix Inc. (CRMD) with a Buy rating and 12-month price target of $5.00.  CorMedix Inc. is a biopharmaceutical company with two leading developing products. The first, Neutrolin, is scheduled to commence a pivotal trial for its potential as a catheter lock solution for the prevention of central venous catheter infection in hemodialysis settings. The second, Deferiprone, should soon enter a Phase II study for the prevention of contrast-induced nephropathy (CIN) in high-risk patients.  Given its insufficient exposure to investors, we believe the stock’s current valuation is not inline with its potential upside. As such, we are recommending CRMD with a Buy rating and 12-month price target of $5.00 for risk-tolerant investors.

 

Investment Thesis:

 

Ø Promising early clinical results bode well for an upcoming pivotal study evaluating Neutrolin in CRBI prevention. Several earlier clinical studies exhibited antimicrobial activities vs. the current standard of care, and the addition of heparin boosted the anticoagulation activities of Neutrolin, which both bode well for the success of the upcoming Neutrolin Phase III study for catheter-related bloodstream infection (CRBI) prevention, in our opinion. We anticipate a pivotal Phase III trial to start in 1H11.

Ø If positive, results from near-term Deferiprone Phase II study in CIN could be an important catalyst. With Deferiprone’s established iron-chelating capability and logical rationale that excess labile iron is a major pathological cause of contrast-induced nephropathy (CIN), we believe a potential positive outcome from the upcoming Phase II biomarker study could clinically validate and substantially increase this asset’s value. The Phase II proof of concept trial in CIN is scheduled to commence in 2Q10, with interim data by YE10 and complete results in 1H11.

Ø Market potential for Neutrolin and Deferiprone is substantial.  Currently, there are not any approved drugs for the two indications that Neutrolin and Deferiprone address.  We estimate the U.S. peak market sales for CRBI prevention in hemodialysis and CIN could reach $250MM and $600MM, respectively.  As a potential first entrant into the market, the stock could realize substantial gains if the products receive approval.

Ø An undervalued stock.  We believe CRMD shares are undervalued based on our comparable analysis of Phase II or III biopharmaceutical peers. We believe our 12-month target price of $5.00 per share would bring the total CorMedix value to $57MM – much more inline with its peer group’s average technology value of $50MM.

 

 

On behalf of:
Yale Jen, PhD

Senior Biotechnology and China Healthcare Analyst

Vice President

212-895-3516

 

Maxim Group LLC

The Chrysler Building

405 Lexington Avenue, 2nd FL

New York, NY 10174

 



Disclosure: No Positions]]> Thu, 03 Jun 2010 11:50:52 -0400 Greetings Everyone!

Buy Rating Initiated at Maxim!

In a nice follow up to my recent positive blog on CorMedix Inc (CRMD), Maxim Group, LLC has initiated coverage of the company with a BUY rating and 12 month price target of $5.00 ($2.60 current price).

The buy-rating and increased coverage should bring more investors into the name, over the next several months ,as clinical trials roll on.

Cormedix offers two late stage drug opportunities with positive early stage data, relatively low clinical risk, in a ddition to a share count and market cap value that will allow for positive pps momentum.

Keep an eye out for CRMD.

 

Initiation                                                                           Buy

CorMedix Inc.    

(CRMD – AMEX – $2.60)

 

Mid- and late-clinical-stage pipeline with encouraging data, unmet medical need, and substantial market potential; Initiating coverage with a Buy rating and $5 price target

 

We are initiating coverage of CorMedix Inc. (CRMD) with a Buy rating and 12-month price target of $5.00.  CorMedix Inc. is a biopharmaceutical company with two leading developing products. The first, Neutrolin, is scheduled to commence a pivotal trial for its potential as a catheter lock solution for the prevention of central venous catheter infection in hemodialysis settings. The second, Deferiprone, should soon enter a Phase II study for the prevention of contrast-induced nephropathy (CIN) in high-risk patients.  Given its insufficient exposure to investors, we believe the stock’s current valuation is not inline with its potential upside. As such, we are recommending CRMD with a Buy rating and 12-month price target of $5.00 for risk-tolerant investors.

 

Investment Thesis:

 

Ø Promising early clinical results bode well for an upcoming pivotal study evaluating Neutrolin in CRBI prevention. Several earlier clinical studies exhibited antimicrobial activities vs. the current standard of care, and the addition of heparin boosted the anticoagulation activities of Neutrolin, which both bode well for the success of the upcoming Neutrolin Phase III study for catheter-related bloodstream infection (CRBI) prevention, in our opinion. We anticipate a pivotal Phase III trial to start in 1H11.

Ø If positive, results from near-term Deferiprone Phase II study in CIN could be an important catalyst. With Deferiprone’s established iron-chelating capability and logical rationale that excess labile iron is a major pathological cause of contrast-induced nephropathy (CIN), we believe a potential positive outcome from the upcoming Phase II biomarker study could clinically validate and substantially increase this asset’s value. The Phase II proof of concept trial in CIN is scheduled to commence in 2Q10, with interim data by YE10 and complete results in 1H11.

Ø Market potential for Neutrolin and Deferiprone is substantial.  Currently, there are not any approved drugs for the two indications that Neutrolin and Deferiprone address.  We estimate the U.S. peak market sales for CRBI prevention in hemodialysis and CIN could reach $250MM and $600MM, respectively.  As a potential first entrant into the market, the stock could realize substantial gains if the products receive approval.

Ø An undervalued stock.  We believe CRMD shares are undervalued based on our comparable analysis of Phase II or III biopharmaceutical peers. We believe our 12-month target price of $5.00 per share would bring the total CorMedix value to $57MM – much more inline with its peer group’s average technology value of $50MM.

 

 

On behalf of:
Yale Jen, PhD

Senior Biotechnology and China Healthcare Analyst

Vice President

212-895-3516

 

Maxim Group LLC

The Chrysler Building

405 Lexington Avenue, 2nd FL

New York, NY 10174

 



Disclosure: No Positions]]> Getting to the 'Cor' of CardioRenal Disease: CorMedix (AMEX: CRMD) http://seekingalpha.com/instablog/651349-douglas-landy/69360-getting-to-the-cor-of-cardiorenal-disease-cormedix-amex-crmd?source=feed 69360 Getting to the ‘Cor’ of CardioRenal Disease: CorMedix Inc. (AMEX:CRMD)
CorMedix Inc. (AMEX:CRMD)is a development stage small-cap specialty pharmaceutical company that that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and renal dysfunction, also known as cardiorenal disease. CorMedix’s ambition is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications, in effect, treating the kidney to treat the heart.
CorMedix, which ‘celebrated’ it’s IPO on April 25, 2010, is a company with two later stage pipeline opportunities, a current market cap of roughly $35MM, and only 11.4MM shares outstanding.
CorMedix currently has several product candidates in clinical development, including its two most advanced product candidates: CRMD003 (Neutrolin) for the prevention of central venous catheter infection and clotting in hemodialysis; CRMD001 (a formulation of the drug Deferiprone) for the prevention of contrast-induced nephropathy in high-risk chronic kidney diseases patients.
CorMedix’s two latest stage products in clinical development include:
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD). The pivotal US study is expected to begin 1H11 with interim data anticipated early in 2012. CorMedix anticipates CE Mark clearance in Europe by year-end.
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD). Phase 2 study expected to begin 2Q10 with interim data anticipated in 4Q10.
 
With all this activity, I believe CorMedix is a company of interest as Neutrolin CE Mark Clearance approaches, and clinical trials continue throughout the next several months.
 

 
Neutrolin
 
The main focus for Cormedix investors will be lead product candidate Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin, Six (6) issued patents – protection through 2019-2025), an antimicrobial catheter lock solution is anticipated to be ready for IDE submission to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end. The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012.
 
Neutrolin uniquely combines the widely employed anti-coagulants (citrate and (heparin-$29MM 2007 Baxter sales)) and the antimicrobial (taurolidine), in a liquid formulation to fill or “lock” central venous catheters (CVC). The initial indication for Neutrolin will be in HD patients with CVCs. However, there are several other potential (revenue expanding) uses including intensive care, total parenteral nutrition (TPN) and CVCs for delivery of chemotherapy agents.
 
The Opportunityfor Neutrolin is anything but small, as the acute care (hospital) setting provides CorMedix ample opportunity for Neutrolin use:
 
 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year.
 
12.5 Million sessions X $15.00 (assumption based on market research)/lock solution = $187.5MM annual in revenue opportunity. (Current market cap ~ $35MM)
 
CVCs are subject to clotting and are associated with catheter-related bloodstream infection (CRBI). There are 160,000 CRBI episodes in the U.S. alone, 6,000 die annually, and the cost to US healthcare system is (roughly) an astounding $1 billion.
 
What makes the opportunity so potentially beneficial to patients in the healthcare setting, is that the current standard of care heparin, assists with preventing clotting, but does not prevent CRBI.
 
Neutrolin for Prevention of CRBI will be supplied via catheter lock solution in almost exactly the same type of vial as the current standard of care, making transition of use relatively seamless for healthcare providers.  
 
The solution contains the active ingredient Taurolidine, a broad-spectrum antimicrobial, targeted to prevent infection and formation of biofilm. Unlike other antibiotics, there has been no observed bacterial resistance to Taurolidine (>14,000 patients exposed), no systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin. The lock solution also contains citrate and heparin (used in hospitals since the 1930’s) as anti-coagulants to prevent thrombus formation and clotting. It is safe and well tolerated. No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients. 
 

 
In the Neutrolin Pivotal Study, CorMedix anticipates starting enrollment H1 2011 for Neutrolin’s prospective, multicenter, double blind, randomized, active comparator study. The study will have approximately 400 patients; study anticipated to be 15 months in duration with the following primary endpoints:
 
1. Freedom from catheter related bloodstream infection – time to event
 
2. Duration of time that adequate catheter function is maintained
 
Neutrolin has demonstrated Clinical Success in early trials: So far Neutrolin has been formidable in preventing infection, over 94% of the time.
 
 
Launch Plan for Neutrolin
CorMedix plans the initial U.S. launch for HD (hemodialysis) indication. This is intended to establish Neutrolin as standard of care for HD patients with CVC. The company expects Neutrolin inclusion on renal guidelines and dialysis providers policy & procedure protocols, and quality of care endorsements for improvement in performance criteria in dialysis networks as the product demonstrates further clinical success in the acute care setting.
 
CorMedix plans to assure reimbursement (revenue capture) by applying for a J code (CMS Reimbursement Code) for Neutrolin. The company plans to have Neutrolin included in bundle for dialysis as a separately billable drug.
 
CorMedix plans to apply for CE mark in EU as soon as quality systems are in place, and to apply for additional indications for CVCs and PICC lines in non-HD indications, adding further potential to the $187.5MM annual opportunity.

 
Deferiprone: The OTHER NEAR TERM pipeline product candidate
 
Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug with a Phase 2 study expected to begin 2Q10 with interim data anticipated in 4Q10. This trial will likely be followed by a larger, pivotal Phase 3 study under a Special Protocol Assessment (SPA) with the FDA. Deferiprone is being developed for the treatment of contrast induced nephropathy (kidney damage associated with medical imaging procedures).
 
More specifically, cardiac interventions use iodinated contrast dye to visualize the coronary vessels. In “high risk patients” undergoing PCI with Chronic Kidney Disease, the dye can cause kidney damage -otherwise known as CIN (Orphan size population of 165,000 patients).
 
CIN is the 3rd most common cause of hospital acquired renal insufficiency, and its consequences go beyond kidney damage, including mortality and significant morbidity. Currently there are no approved or near-term pharmaceutical therapies to treat this problem.
 
Catalytic iron and oxidative stress are felt to contribute significantly to the underlying cause of CIN. Contrast dye exposure is associated with increased urinary catalytic iron, and thus removal of catalytic iron by deferiprone, has been shown to be protective in an animal model of CIN.
 
Other earlier stage CorMedix opportunities include the following:
       
1.       CRMD002 – the development and commercialization of a readily available biomarker test for urine labile iron will be supportive to the development and subsequent potential commercialization of Deferiprone (CRMD001).
 
2.       CRMD004 is a novel thixotropic (changes from semi-solid state to free-flowing liquid under pressure generated upon insertion / withdrawal from a catheter) gel formulation in pre-clinical development. CRMD004 could be combined with taurolidine, other antimicrobials, anticoagulants or enzymes for use as a catheter lock solution with the potential to extend the benefits of Neutrolin.

 
 
CorMedix Financials
 
 
Cash
11.7MM
Debt
None
Capital Structure
   Common Stock
11.4MM
   Options
1.6MM
   Warrants
4.8MM
Shares Outstanding
17.8MM
Market Capitalization
35.6MM
 
Disclosure: No Position in CorMedix


Disclosure: No Positions]]> Tue, 18 May 2010 13:20:57 -0400 Getting to the ‘Cor’ of CardioRenal Disease: CorMedix Inc. (AMEX:CRMD)
CorMedix Inc. (AMEX:CRMD)is a development stage small-cap specialty pharmaceutical company that that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and renal dysfunction, also known as cardiorenal disease. CorMedix’s ambition is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications, in effect, treating the kidney to treat the heart.
CorMedix, which ‘celebrated’ it’s IPO on April 25, 2010, is a company with two later stage pipeline opportunities, a current market cap of roughly $35MM, and only 11.4MM shares outstanding.
CorMedix currently has several product candidates in clinical development, including its two most advanced product candidates: CRMD003 (Neutrolin) for the prevention of central venous catheter infection and clotting in hemodialysis; CRMD001 (a formulation of the drug Deferiprone) for the prevention of contrast-induced nephropathy in high-risk chronic kidney diseases patients.
CorMedix’s two latest stage products in clinical development include:
 
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD). The pivotal US study is expected to begin 1H11 with interim data anticipated early in 2012. CorMedix anticipates CE Mark clearance in Europe by year-end.
 
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD). Phase 2 study expected to begin 2Q10 with interim data anticipated in 4Q10.
 
With all this activity, I believe CorMedix is a company of interest as Neutrolin CE Mark Clearance approaches, and clinical trials continue throughout the next several months.
 

 
Neutrolin
 
The main focus for Cormedix investors will be lead product candidate Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin, Six (6) issued patents – protection through 2019-2025), an antimicrobial catheter lock solution is anticipated to be ready for IDE submission to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end. The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012.
 
Neutrolin uniquely combines the widely employed anti-coagulants (citrate and (heparin-$29MM 2007 Baxter sales)) and the antimicrobial (taurolidine), in a liquid formulation to fill or “lock” central venous catheters (CVC). The initial indication for Neutrolin will be in HD patients with CVCs. However, there are several other potential (revenue expanding) uses including intensive care, total parenteral nutrition (TPN) and CVCs for delivery of chemotherapy agents.
 
The Opportunityfor Neutrolin is anything but small, as the acute care (hospital) setting provides CorMedix ample opportunity for Neutrolin use:
 
 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year.
 
12.5 Million sessions X $15.00 (assumption based on market research)/lock solution = $187.5MM annual in revenue opportunity. (Current market cap ~ $35MM)
 
CVCs are subject to clotting and are associated with catheter-related bloodstream infection (CRBI). There are 160,000 CRBI episodes in the U.S. alone, 6,000 die annually, and the cost to US healthcare system is (roughly) an astounding $1 billion.
 
What makes the opportunity so potentially beneficial to patients in the healthcare setting, is that the current standard of care heparin, assists with preventing clotting, but does not prevent CRBI.
 
Neutrolin for Prevention of CRBI will be supplied via catheter lock solution in almost exactly the same type of vial as the current standard of care, making transition of use relatively seamless for healthcare providers.  
 
The solution contains the active ingredient Taurolidine, a broad-spectrum antimicrobial, targeted to prevent infection and formation of biofilm. Unlike other antibiotics, there has been no observed bacterial resistance to Taurolidine (>14,000 patients exposed), no systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin. The lock solution also contains citrate and heparin (used in hospitals since the 1930’s) as anti-coagulants to prevent thrombus formation and clotting. It is safe and well tolerated. No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients. 
 

 
In the Neutrolin Pivotal Study, CorMedix anticipates starting enrollment H1 2011 for Neutrolin’s prospective, multicenter, double blind, randomized, active comparator study. The study will have approximately 400 patients; study anticipated to be 15 months in duration with the following primary endpoints:
 
1. Freedom from catheter related bloodstream infection – time to event
 
2. Duration of time that adequate catheter function is maintained
 
Neutrolin has demonstrated Clinical Success in early trials: So far Neutrolin has been formidable in preventing infection, over 94% of the time.
 
 
Launch Plan for Neutrolin
CorMedix plans the initial U.S. launch for HD (hemodialysis) indication. This is intended to establish Neutrolin as standard of care for HD patients with CVC. The company expects Neutrolin inclusion on renal guidelines and dialysis providers policy & procedure protocols, and quality of care endorsements for improvement in performance criteria in dialysis networks as the product demonstrates further clinical success in the acute care setting.
 
CorMedix plans to assure reimbursement (revenue capture) by applying for a J code (CMS Reimbursement Code) for Neutrolin. The company plans to have Neutrolin included in bundle for dialysis as a separately billable drug.
 
CorMedix plans to apply for CE mark in EU as soon as quality systems are in place, and to apply for additional indications for CVCs and PICC lines in non-HD indications, adding further potential to the $187.5MM annual opportunity.

 
Deferiprone: The OTHER NEAR TERM pipeline product candidate
 
Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug with a Phase 2 study expected to begin 2Q10 with interim data anticipated in 4Q10. This trial will likely be followed by a larger, pivotal Phase 3 study under a Special Protocol Assessment (SPA) with the FDA. Deferiprone is being developed for the treatment of contrast induced nephropathy (kidney damage associated with medical imaging procedures).
 
More specifically, cardiac interventions use iodinated contrast dye to visualize the coronary vessels. In “high risk patients” undergoing PCI with Chronic Kidney Disease, the dye can cause kidney damage -otherwise known as CIN (Orphan size population of 165,000 patients).
 
CIN is the 3rd most common cause of hospital acquired renal insufficiency, and its consequences go beyond kidney damage, including mortality and significant morbidity. Currently there are no approved or near-term pharmaceutical therapies to treat this problem.
 
Catalytic iron and oxidative stress are felt to contribute significantly to the underlying cause of CIN. Contrast dye exposure is associated with increased urinary catalytic iron, and thus removal of catalytic iron by deferiprone, has been shown to be protective in an animal model of CIN.
 
Other earlier stage CorMedix opportunities include the following:
       
1.       CRMD002 – the development and commercialization of a readily available biomarker test for urine labile iron will be supportive to the development and subsequent potential commercialization of Deferiprone (CRMD001).
 
2.       CRMD004 is a novel thixotropic (changes from semi-solid state to free-flowing liquid under pressure generated upon insertion / withdrawal from a catheter) gel formulation in pre-clinical development. CRMD004 could be combined with taurolidine, other antimicrobials, anticoagulants or enzymes for use as a catheter lock solution with the potential to extend the benefits of Neutrolin.

 
 
CorMedix Financials
 
 
Cash
11.7MM
Debt
None
Capital Structure
   Common Stock
11.4MM
   Options
1.6MM
   Warrants
4.8MM
Shares Outstanding
17.8MM
Market Capitalization
35.6MM
 
Disclosure: No Position in CorMedix


Disclosure: No Positions]]> (AMEX)