CorMedix (AMEX:CRMD) - Michael Sweeney

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CorMedix (AMEX:CRMD) 0 comments

Jun 3, 2010 12:45 PM
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.

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)
Shares Outstanding – 11.4M
Market Cap – $35.6M
Net Loss 1Q10 – ($6.8M)
Cash/Equivalents – $11.7M
Total Liabilities – $1.4M
Loss from Operations ITD – ($32.2M)
Research & Development ITD – ($15.6M)

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.

Market Opportunity
- 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year
- CVCs are subject toclotting and are associated with catheter-related bloodstream infection (CRBI)
- 160,000 CRBI episodes in the U.S. alone, 6,000 die annually1
- Cost to US healthcare system is $1 billion
- Standard of care (heparin) does not prevent CRBI
Neutrolin for Prevention of CRBI:
- A catheter lock solution for the prevention of CRBI and maintenance of catheter function in HD patients
- Contains Taurolidine, a broad-spectrum antimicrobial
- Prevents infection and formation of biofilm
- No observed bacterial resistance – unlike antibiotics
- >14,000 patients exposed to taurolidine
- No systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin
- Contains citrate and heparin as anti-coagulants
- Prevents thrombus formation and clotting
- Safe and well tolerated
- No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients
Six (6) issued patents – protection through 2019-2025

Market Opportunity
- 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
- CIN consequences go beyond kidney damage, including mortality and significant morbidity
- No approved or near-term pharmaceutical therapies
- Catalytic iron and oxidative stress are felt to contribute significantly to the underlying cause of CIN
- Contrast exposure is associated with increased urinary catalytic iron
- Removal of catalytic iron shown to be protective in an animal model of CIN
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.
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
Themes: corrmedix, crmd, cancer, biotech

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