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  Money Shot

Cambridge Heart Induces Tachycardia

March 21, 2006 -  If you said that StopPagingMe.com's 'The Money Shot' has championed the micro-cap stock Cambridge Heart (CAMH) you would be right. Since we first mentioned it at $0.35, the T-wave Alternans specialists have benefited from excellent data published in major cardiac journals, a host of AICD problems encouraging the medical community to look for more discriminating implantation criteria and finally increasing insurance reimbursement, culminating in today's positive national coverage decision by the Centers for Medicare and Medicaid Services(CMS). The result, a nearly 1000% profit margin, topping off at $3.98 early last week.

Investors awaiting the CMS' national coverage decision today were biting their fingernails as the stock dropped more than 15% without any news depsite all sources saying March 21st would deliver the verdict. As we write this article, only Bloomberg and the Cambridge Heart website confirm the positive decision that CMS has indeed approved national coverage for Microvolt T-wave Alternans when the spectral analytic method is used (a method unique to CAMH's machine). Well, let us be the first to congratulate those who know a good product and good data when they see it. The NCD was positive and the stock should reflect as much when the bell rings tomorrow.

CMS Decision Summary

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The Money Shot: Heart Healthy Recommendations

This episode of The Money Shot is in honor of the upcoming American College of Cardiology (ACC) meeting, beginning March 12th. Attending one of these conferences is impressive for the shear numbers of people that wake up early to hear the Late Breaking Clinical Trials results. The investigators speak from a tiny podium before an airplane hangar-sized auditorium while the data is projected on enormous screens everyone fixated on  p-values and conclusions, like some weird cult listening to their leader. As soon as the “money slide” appears and conffrims success or failure, the non-medical people jump from their seats, whip out their cell phones, and the stock reflects the data 10 minutes later.

This year’s conference promises to have some important Late Breaking results. Here’s what to watch for:

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The Money Shot: 3 for the Road

Sanofi (SNY) - $$ - Selling at around $46, it‘s no bargain but the world’s third largest pharmaceutical company has quite a few in the pipeline and just made a $3.1 billion sale to Pfizer for their share of the inhaled insulin hopeful, Exubera. Many of us, aka me, are still confident that Acomplia (rimonabant), the endocannabinoid blocker will be successful – how can you go wrong with a drug that reverses the munchies?

Now they are filing a new drug application (NDA) for an old friend: Plavix. And you know what we (me again) say about Plavix (clopidogrel): it never loses. The new indication, which is to receive expedited review by the FDA is for ST-elevation MIs. What you have to know about this is that it’s basically the only indication they don’t have in treatment of coronary artery disease. Recent large scale studies have indeed demonstrated benefit in this setting so there’s no reason to think it would be rejected. http://www.sanofi-aventis.us/

Genta (GNTA) - $ - A good prospect at $1.80? We think so and we were right about Cambridge Heart (CAMH).  The Genasense® (oblimersen sodium) Injection is the Company's hot product from its oligonucleotide program...

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Money Shot: We’re Not Gonna Say It, But…

CAMBRIDGE HEART (CAMH) - We told you so. The recent tripling of Cambridge Heart’s value has been something StopPagingMe.com has been chirping about for almost a year.

 

Granted, it didn’t have far to go to triple in value ($0.29 to $0.87), but you still end up with 3x more money then when you started. Why the sudden increase in value and trading volume?

 

Well, the Journal of American College of Cardiology (JACC) published an NIH-sponsored study ("Microvolt T-Wave Alternans and the Risk of Death or Sustained Ventricular Arrhythmias in Patients with Left Ventricular Dysfunction.") online showing that the microvolt t-wave alternans (mTWA) study is a far better predictor of who benefits from AICD implantation than ejection fraction, the current predictor by way of the SCD-HeFT and MADIT-2 trials. Following this publication, the stock inched up about $0.05. The big bump occurred about one week later when the Center for Medicare and Medicaid Services (CMS) proposed a national coverage decision for mTWA for patients at risk for sudden cardiac death.

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The Money Shot - Imclone Short Changed?

There are just some companies out there that despite repeated failures, maintain a strong market presence. Imclone Systems Inc (IMCL) is o­ne of those. Despite the rocky road it has traveled over the past 2 years, it’s o­ne and o­nly product, Erbitux, has kept it from plummeting off the Nasdaq exchange altogether.

After peaking at more than $80 in July 2004, the company’s CEO, Sam Waksal, faced very public and embarrassing insider trading allegations for which he is now in prison. Also involved were his brother, Harlan, and uber-homemaker/CEO Martha Stewart who also served prison time for her premature dumping of the stock before word of its 2001 FDA rejection became public.
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Sugar, Mama: The Inhaled Insulin Race- The Money Shot IV

Inhaled insulin is finally moving out of the realm of implausibility and Wall Street is racing to predict who will reap the sweet rewards.

Considering all the hoopla generated over the recent positive data o­n Imclone's (IMCL) only drug, Erbitux, you would figure that the imminent inhaled insulin battle would plunge the biotech industry into turmoil.

Erbitux, which originally was intended to treat late-stage colon CA, also showed positive results in head and neck CA trials. This can expand its patient population to what, 20,000 more people annually?
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Money Shot Part II: Getting Started

It’s been nearly a month since I wrote the first edition of The Money Shot Part I: Getting Excited. In the last episode we talked about the advantages that you, as young well-read docs, have over the biotech analyst and regular ol’ stock trader. That is, you have an intimate knowledge of the formulary and what attendings are prescribing as well as the background knowledge to help you understand the myriad news published daily about drug trials.

I concluded last month’s piece by promising to give you a good way to introduce yourself to the world of biotech/pharm stocks- so here it is:
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The Money Shot: Ximelagatran Bares All

Ximelagatran, aka Coumadin-lite, has been struggling to earn FDA approval. The drug, not currently approved for the U.S. market because of questions about liver damage, appears to be as effective as other common therapies for preventing strokes and recurring blood clots, according to studies published o­n Tuesday.

AstraZeneca
's wonder-pill, is so intriguing because it is oral anticoagulation that does not require INR levels to be checked and is a helluva lot easier to give at home than Lovenox. It has already been approved for short-term use in parts of Europe. Why is this a subject for The Money Shot crew? Well, Astra-Zeneca (AZN) was selling at $50 o­ne year ago and now sits tenuously at $39. Arguably, much of this drop is secondary to its failure to gain approval for Exanta in the US. Read more
 

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