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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,... More
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  • Another 'Buy Rating' for the 'Cor'!
    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
    Tags: CRMD
    Jul 15 11:56 AM | Link | Comment!
  • Buy Rating for the 'COR'; Cormedix Gaining Attention:

    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
    Jun 03 11:50 AM | Link | Comment!
  • Getting to the 'Cor' of CardioRenal Disease: CorMedix (AMEX: CRMD)
    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
    Tags: (AMEX)
    May 18 1:20 PM | Link | Comment!
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