Вы находитесь на странице: 1из 25

Company Overview April 2011

NYSE Amex: CRMD


www.cormedix.com
2011 CorMedix Inc.

Forward Looking Statements

This presentation contains certain statements that constitute forward-looking statements within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. The forward looking statements in this presentation include statements about our business, including results of clinical trials, potential indications for our product candidates, development timelines and future events that have not yet occurred. Pharmaceutical development inherently involves significant risks and uncertainties, including the risks outlined in Risk Factors in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11th, 2011. Our actual results may differ materially from our expectations due to these risks and uncertainties, including our dependence on the success of our lead product candidates, and factors relating to regulatory approval, research and development, intellectual property protection, competition, industry environment, ability to raise sufficient capital and other matters. Any forward-looking statements included in this presentation are based on information available to us on the date of this presentation. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

2011 CorMedix Inc.

Experienced Team

John C. Houghton - President and CEO


Stryker Biotech - Global Head Sales and Marketing Lederle/Wyeth, Rhone-Poulenc, Aventis

Mark A. Klausner, MD - Chief Medical Officer


Previously a Practicing Academic Nephrologist J&J, Wyeth Medical Affairs, Clinical R&D, Drug Safety

Brian Lenz - Chief Financial Officer


Public and Private company CFO experience VioQuest Pharmaceuticals, Arno Therapeutics, KPMG, LLP

2011 CorMedix Inc.

Company Highlights

Two products entering late stage clinical development


Neutrolin for the prevention of catheter related bloodstream infection (CRBI) and maintenance of catheter patency in hemodialysis (HD) patients Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients

Reduced development and regulatory risk


Neutrolin: Successful U.S. Pilot study; Established use in EU markets Deferiprone: Available in 50 countries for other indications; Approved regulatory path (SPA) with FDA

Worldwide commercialization rights Pipeline of additional products and indications


2011 CorMedix Inc.

Product Pipeline

PRODUCT

INDICATION

PRECLINICAL

PILOT

PIVOTAL

Neutrolin
(CRMD003)

Prevention of CRBI* Prevention of CRBI

Thixotropic Gel (CRMD004)

PRODUCT

INDICATION

PRECLINICAL

PHASE I

PHASE II

PHASE III

Deferiprone
(CRMD001)

Prevention of CIN Treatment of CKD Diagnostic Test

Deferiprone
(CRMD001)

Urine Catalytic Iron Test (CRMD002)


*

CRBI Catheter Related Bloodstream Infection

2011 CorMedix Inc.

Neutrolin

2011 CorMedix Inc.

Central Venous Catheter Therapeutic Market in Hemodialysis

80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year CVCs are subject to clotting and can result in catheter related bloodstream infection (CRBI) 160,000 CRBI episodes in the U.S. alone1, 6,000 die annually Cost to US healthcare system could approach $1 billion annually2 Standard of care (heparin) does not prevent CRBI
1

Allon AJKD 51(2):165-168, 2008 2 Manierski Adv Chronic Kidney Dis 13(3):245, 2006
2011 CorMedix Inc.

Neutrolin: For the Prevention of CRBI

A catheter lock solution for the prevention of CRBI and maintenance of catheter patency in HD patients Contains taurolidine, an anti-microbial
Prevents infection and formation of biofilm No observed bacterial resistance - unlike antibiotics >14,000 patients exposed to taurolidine No systemic toxicity at levels 400x the amount contained in 5mL of Neutrolin

Contains citrate and heparin, both anti-coagulants


Prevents thrombus formation and clotting

Safe and well tolerated


No AEs related to Neutrolin in previous catheter lock studies

2011 CorMedix Inc.

Neutrolin Prevents Biofilm Formation

Untreated 24 Hours

Heparin 7 Months

Neutrolin 5 Months

Biofilm on Intravenous Catheter

Biofilm with microbial colonization completely covers surface

No biofilm or microbial colonization

Photos taken from the Quarello, F et al, Blood Purif 2002; 20: 87-92

2011 CorMedix Inc.

Neutrolin Pilot Study Completed


CRBI at 90 days was lower among patients who received Neutrolin than among control patients who received heparin
Neutrolin

CRBI events per 1000 days

5 4 3 2 1 0

heparin

Pre ____ Neutrolin ------- heparin P < .001

Neutrolin P < .02

Post

Adapted from: Allon M, Clin Infect Dis 2003; 36:1539-1544.

2011 CorMedix Inc.

10

Neutrolin Demonstrated Effectiveness

Study

Number of patients

Average duration (days)

Control group

Neutrolin % patients without infection

20 pts Neutrolin 30 pts heparin

85

heparin 5000 u/mL case-control heparin 5000 u/mL

94

58

158

100

76

250

none

96

1. Allon M Clin Infect Dis (2003) 36 (12):1539-44 2. Betjes Nephrol Dial Transplant (2004) 19:1546-1551 3. Sodemann K et al Poster: ASN 2001

2011 CorMedix Inc.

11

Neutrolin Pivotal Study Plan

Prospective, multicenter, double blind, randomized, active control study 400 patients; 15 months duration
(9 months recruitment, 6 months follow up)

Active control heparin 1,000 U/mL Co-primary endpoints:


Up to 180 day freedom from CRBI Up to 180 day maintenance of catheter patency

2011 CorMedix Inc.

12

Neutrolin Commercial Plan


Initial U.S. launch by CorMedix for HD patients with CVC
Establish Neutrolin as standard of care Seek inclusion in renal guidelines and dialysis providers policy & procedure protocols Seek quality of care endorsements for improvement in performance criteria in dialysis networks

Reimbursement
Apply for a J code - separately billable product (outside bundle) Seek inclusion in bundle Positive political environment: healthcare policy of preventative medicine, nonpayment for hospital acquired infection

Apply for CE mark and commence commercial launch planning in EU Apply for additional indications for non-HD CVCs and PICC lines

2011 CorMedix Inc.

13

Neutrolin IP Overview

6 issued patents providing protection through 2019-2025 A method of inhibiting or preventing infection and blood coagulation at a medical prosthetic device using a pharmaceutical composition comprising taurolidine and citric acid A locking solution comprising a taurinamide derivative, a biologically acceptable acid and low concentration heparin Additional filings under prosecution to extend protection

2011 CorMedix Inc.

14

Deferiprone

2011 CorMedix Inc.

15

Contrast Induced Nephropathy (CIN) Market Overview


Cardiac interventions use X-ray and iodinated contrast dye to visualize coronary vessels In high risk patients undergoing PCI* with Chronic Kidney Disease, the dye can cause acute kidney damage otherwise known as CIN 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

* PCI Percutaneous Coronary Intervention

2011 CorMedix Inc.

16

Catalytic Iron Causes Tissue and Cell Injury

CKD patient has a pre-existing excess of catalytic iron and oxidative stress the perfect storm
nmol / mg Cr

7.0 6.0 5.0

Baseline 48 hours after IVP


P<0.001

Contrast exposure is associated with a further increase in catalytic iron1 Catalytic iron and oxidative stress contribute significantly to the underlying cause of CIN Removal of catalytic iron shown to be protective in an animal model of CIN

4.0 +115% 3.0 2.0 1.0 0.0

Urinary catalytic iron

Rajapurkar M et al Urinary catalytic (bleomycin-detectable) iron following radiocontrast exposure in healthy kidney donors ASN 2006

2011 CorMedix Inc.

17

Deferiprone for Reducing Catalytic Iron


Deferiprone launched in 1999, available in >50 Ex-US countries for the treatment of Thalassemia Major Deferiprone efficacy and safety is well characterized several thousand patients treated CorMedix in-licensed method of use and formulation patents of deferiprone CorMedix has finalized a PK study showing the benefit of extended release formulations less nausea/vomiting Compared to other iron chelators, deferiprone is:
Superior at penetrating cells and sub-cellular compartments1 Selectively binding catalytic iron
1 Glickstein

et al. Blood 108: 3195, 2006

2011 CorMedix Inc.

18

Deferiprone Competitive Landscape


Deferiprone CRMD001
Oral IR/ER (b.i.d.) No Yes

Attribute
Route Renal Toxicity Active drug in urine Method of use and formulation patents in cardiorenal disease Effective at redistributing iron/ membrane permeable Launch date

Deferiprone Ferriprox (1)


Oral IR (t.i.d.) No Yes

Desferasirox Exjade (2)


Oral daily Yes (Black Box) No

Deferoxamine Desferal (3)


I.V./S.C. No Yes

Yes

No

No

No

Yes

Yes

No

No

N/A

1999

2006

1970s

(1) Registered Trademark of Apopharma Inc. (2) Registered Trademarks of Novartis (3) Also known as desferrioxamine, desferoxamine

2011 CorMedix Inc.

19

Deferiprone Development Plan


Regulatory Complete a small biomarker Phase II proof of concept trial Commence planning for Phase III CIN study pending Phase II results Clinical Proof of concept trial Commenced enrollment in Q2 2010 Double-blind, placebo controlled - 8 days deferiprone vs. placebo High risk CKD population 60 patients total, interim analysis at 30 patients completed
Favorable safety profile - no drug related SAEs

Primary endpoint: panel of biomarkers, which include: cystatin C, NGAL, LFABP Secondary endpoints: clinical outcomes and persistent changes in kidney function

2011 CorMedix Inc.

20

Deferiprone Commercial Plan

Specialty care sales force 50; focused on high decile catheter labs Seek inclusion on catheter lab guidelines Seek inclusion on Diagnosis-Related Group as a new tech add on Market uptake expected to be faster than typical new product launches due to morbidity/mortality claim and absence of alternative therapies

2011 CorMedix Inc.

21

Deferiprone IP Overview

Specific CIN patent under prosecution Anticipate Hatch Waxman 5 year marketing exclusivity if gain first approval of deferiprone in U.S. 8 issued patents for treating progressive kidney disease Additional filings under prosecution

2011 CorMedix Inc.

22

Achievements & Anticipated Milestones

TIMING

ACHIEVEMENTS & MILESTONES

2010

Deferiprone: Neutrolin: Neutrolin:

Started phase II CIN study Commenced application process for CE mark in EU IDE submitted Interim analysis of phase II CIN study Start of pivotal clinical study Submit CE mark application in EU Potential launch in EU Data on phase II CIN study Commence planning for phase III CIN study Interim analysis of pivotal clinical study

1H 2011

Deferiprone: Neutrolin: Neutrolin: Neutrolin: Deferiprone: Deferiprone: Neutrolin:

2H 2011

2011 CorMedix Inc.

23

Financial Overview

(all figures in millions)

Period Ended: 12/31/10 7/28/06 (Inception) 12/31/10 $18.0 $7.8 $25.8

R&D G&A Total Loss From Operations

$5.5 $3.0 $8.5*

Cash Position Common Shares Outstanding Fully Diluted Shares Outstanding

$8.3 11.4 17.8

*Loss From Operations Includes $3.5M of Non-Cash Expenses

2011 CorMedix Inc.

24

Company Highlights

Two products entering late stage clinical development Reduced development and regulatory risk Worldwide commercialization rights Pipeline of additional products and indications

2011 CorMedix Inc.

25

Вам также может понравиться