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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.
Experienced Team
Company Highlights
Product Pipeline
PRODUCT
INDICATION
PRECLINICAL
PILOT
PIVOTAL
Neutrolin
(CRMD003)
PRODUCT
INDICATION
PRECLINICAL
PHASE I
PHASE II
PHASE III
Deferiprone
(CRMD001)
Deferiprone
(CRMD001)
Neutrolin
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.
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
Untreated 24 Hours
Heparin 7 Months
Neutrolin 5 Months
Photos taken from the Quarello, F et al, Blood Purif 2002; 20: 87-92
5 4 3 2 1 0
heparin
Post
10
Study
Number of patients
Control group
85
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
11
Prospective, multicenter, double blind, randomized, active control study 400 patients; 15 months duration
(9 months recruitment, 6 months follow up)
12
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
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
14
Deferiprone
15
16
CKD patient has a pre-existing excess of catalytic iron and oxidative stress the perfect storm
nmol / mg Cr
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
Rajapurkar M et al Urinary catalytic (bleomycin-detectable) iron following radiocontrast exposure in healthy kidney donors ASN 2006
17
18
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
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
19
Primary endpoint: panel of biomarkers, which include: cystatin C, NGAL, LFABP Secondary endpoints: clinical outcomes and persistent changes in kidney function
20
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
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
22
TIMING
2010
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
2H 2011
23
Financial Overview
24
Company Highlights
Two products entering late stage clinical development Reduced development and regulatory risk Worldwide commercialization rights Pipeline of additional products and indications
25