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  • An Opportunity Amongst Uncertainty (OTC:MCUJ) 3 comments
    Sep 25, 2009 3:34 AM

    Medicure Inc.

    (Public, OTC:MCUJ)

    We all love that feel good story of a company riddled with uncertainty and financial distress, which bounces back and maximizes its opportunity. Medicure Inc. (OTC:MCUJ) offers just that, and more. A company whose entity and nature had long been forgotten, barely clinging on low volume, yet glistening with potential. A true diamond in the rough, the lone white rose in a field full of reds. Their main product, Aggrastat, targets a market potential of $450M and is already FDA approved for the treatment of Acute Coronary Syndrome, the other four products are currently under clinical trials. Deep pipeline, large potential market, and a need for financing — A story that sounds all too familiar for experienced biotech investors, so the real question becomes — What makes Medicure special?


    About Medicure Inc.

    Medicure is a specialty pharmaceutical company established in 1997. The Company’s vision is to become a leading specialty pharmaceutical company in the commercialization and development of unique small molecule pharmaceuticals in the cardiovascular and neurological fields for unmet medical needs.

    Medicure’s core focus is on the U.S. commercial sales of its FDA approved small molecule, AGGRASTAT. Acquired in 2006, AGGRASTAT is experiencing renewed interest from hospitals and clinicians in the U.S. due to its compelling clinical and economic evidence. The Company has an experienced commercial team in the U.S. dedicated exclusively to the marketing of AGGRASTAT.

    AGGRASTAT, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction (NYSE:MI), or refractory ischemia/repeat cardiac procedure.

    Medicure opportunistically looks at small molecule development opportunities and currently has development programs in the neurology and cardiology fields.

    Products

    Clinical Studies

    Medicure Inc. (NYSE:USA) announced the positive results of two large AGGRASTAT (tirofiban) studies, MULTI-STRATEGY 2 and ON-TIME 2, that were presented at the Late Breaking Sessions of the American College of Cardiology. The 745-patient MULTI-STRATEGY 2 study demonstrated that high-dose tirofiban is non-inferior to REOPRO(NYSE:R) (abciximab) during primary percutaneous coronary intervention (NYSE:PCI) for acute myocardial infarction. The incidence of death/MI at 8 months was 5.9% vs. 7.5% (p equals 0.55) between tirofiban and abciximab. The 984-patient ON-TIME 2 study showed that treatment with tirofiban in addition to aspirin, heparin and clopidogrel, significantly reduced the incidence of residual ST-segment deviation after PCI in STEMI patients versus placebo (patients treated with aspirin, unfractioned heparin and clopidogrel). Study results also showed that the combined incidence of death, recurrent myocardial infarction (MI), urgent target vessel revascularization (uTVR), and thrombotic bailout was significantly reduced in the tirofiban group (26.0 percent) versus placebo (33.3 percent; p equals 0.013). Early intervention with tirofiban did not result in a significant increase of major bleeding when compared to placebo (4.0 percent versus 2.9 percent, respectively; p equals 0.363); results for minor bleeding were consistent with this trend (6.1 percent of tirofiban-treated patients versus 4.4%; p equals 0.233).

    About Acure Coronary Syndrome / Target Market

    Acute coronary syndromes result from a sudden blockage in a coronary artery. This blockage causes unstable angina or heart attack (myocardial infarction) depending on the location and amount of blockage.

    • People who experience an acute coronary syndrome usually have chest pressure or ache, shortness of breath, and fatigue.
    • People who think they are experiencing an acute coronary syndrome should call for emergency help and then chew an aspirin tablet.
    • Doctors use electrocardiography (ECG) and measure substances in the blood to determine whether a person is experiencing an acute coronary syndrome.
    • Treatment varies depending on the type of syndrome but usually includes attempts to increase blood flow to affected areas of the heart.

    In the United States, more than 1.5 million people have a heart attack each year. About 400,000 to 500,000 of them die, half before they reach the hospital. Almost all of them have underlying coronary artery disease and about two thirds of them are men.

    Furthermore, Aggrastat has also been proven to significantly improve outcomes among patients with NSTEMI, a sub group of Acute Coronary Syndrome. So you must now be asking yourself — Well, what the heck does NSTEMI stand for? Quite simple really, Non-ST-segment Elevation Myocardial Infarction, how about that for a tongue twister.

    NSTEMI constitutes an important sub group of ACS. In fact it  forms the major  group. Real world data would indicate it   UA/NSTEMI could form up to 75% of all admissions for ACS in any cardiac emergency units.

    All of these constitute to a $450M target market for Aggrastat alone.

    Phase II Trials

    Medicure Inc. (USA) announced that it has received Health Canada, Therapeutic Products Directorate approval for a Phase II clinical study of Avastrem for the treatment of tardive dyskinesia (NYSE:TD). The Company anticipates enrollment to begin in March 2009. This 12-week, randomized, double-blind, placebo-controlled, parallel group comparative study will evaluate the safety and efficacy of Avastrem in the treatment of TD, a common side effect of antipsychotic medications which are used to treat schizophrenia and schizoaffective disorders. Approximately 4 million people in the United States receive antipsychotic drugs of which approximately 5 to 20% have TD. The primary objective of the Phase II study is to assess the beneficial effect of Avastrem on the reduction of expressed symptoms of TD compared to placebo. The Abnormal Involuntary Movement Scale (AIMS) will be used to assess the improvement in symptoms after treatment from baseline through to week 12. The study will enroll approximately 140 patients with a planned interim analysis about mid way.

    For the other three Products visit the company website.

    Technical Chart Analysis ( click image to enlarge )

    Today, MCUJ clearly broke a year-long resistance level at .05 cents (in the Red circle on the chart) and also exceeded the corresponding top trend-line of a very well-established price channel!  This move indicates the price channel (Blue lines on the chart) may have expanded and the previous top trend-line (dashed Blue line on the chart) now appears to be the new mid-line.  Typically, one doubles the height of the previous channel and this could indicate the new top trend-line is near the .09 cent level.  With heavy volume under the tall green candles these past two days (Grey volume bars), this stock is poised to carry on well into the upper levels of the freshly expanded price channel and possibly beyond.  This was a strong move and coincides with the standard bullish signal of the daily 100 SMA (Orange line) currently running above the daily 200 SMA (Yellow line).  Another interesting aspect of this chart is that the price hasn’t been to the bottom trend-line of the price channel since early this year and this current rise actually started well above that bottom trend-line, this could indicate that the channel has not only expanded but it is rising.  And with that, it’s good to keep in the back of your mind that in July 2008 this stock hit .10 cents and that’s over a 70% gain from yesterday’s close.

    Overall Sentiment

    So you’ve invested in MCUJ, and you’re worried that the price might dip. Consider this, the company has recently been delisted from the American Stock Exchange (Amex), they’ve had to undergo the past few years paying off debts and loans, and on top of that faced the recent economic recession. If you think this stock isn’t undervalued after all of this, you clearly haven’t been around the small cap block many times before. The launching of a new clinical program for Avastram, planned financial and management restructuring, and products with target potentials in the billions, expect MCUJ to finally gain some much needed attention from potential investors, leading to a potentially more stable future. This company can be summed up in one simple statement: High risk, high reward.

    ———–

    Disclosure: Short term position in MCUJ
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Comments (3)
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  • great article
    , contributor
    Comments (3) | Send Message
     
    well researched and informative article. Thanks.
    25 Sep 2009, 08:35 PM Reply Like
  • Joseph Krueger
    , contributor
    Comments (283) | Send Message
     
    A follow-up to your article.
    seekingalpha.com/insta...
    6 Oct 2009, 03:10 PM Reply Like
  • Go MDUJ
    , contributor
    Comments (3) | Send Message
     
    they have so much debt. 125 million. Do you think they can ever climb out of the whole. their current products is not sufficient given current trend. they other drug phase II still has a long shot. I bought MDUJ because of a quick potential 5 bagger, but do you really think this is going to come out of the whole?
    17 Oct 2009, 01:18 AM Reply Like
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