I am the 1 person in every 500 people in most countries who has high cholesterol. I don't smoke, I exercise moderately, take Lipitor and attempt to take Niacin and Colestipol to reduce my cholesterol levels. Of the drugs, all have some side effects, some worse then others.
With Lipitor (which does a great job of lowering most cholesterol risk markers) there is always the worry of liver damage, muscle cramping and potential memory loss. With Niacin and Colestipol, well - they work great at making me flush and fart.
So you say, "I'm one of the 499 with fairly normal cholesterol. Why should I care?" You should care because about 50% of people who suffer heart attacks or stokes have normal cholesterol. Yes, read that again.
Those people with otherwise normal cholesterol, who suffer heart attacks or strokes, often have a high hsCRP (high sensitivity C reactive protein) value. (Jupiter study - Dr Paul Ridker - New England Journal of Medicine, Nov. 20, 2008) Do you know what your hsCRP value is?
This brings me to the potential of Amarin's (NASDAQ:AMRN) product AMR 101.
AMR101 is 96% pure EPA (no DHA) extracted from fish oil. It has shown a remarkable ability to lower cardiac and stroke, risk markers (including hsCRP), in Amarin's phase 111 trials (Marine and Anchor) without the risks of Lipitor (and other Statins) or the unpleasant side effects that some experience with Niacin or Colestipol.
Currently, Amarin has filed a NDA (New Drug Application) with the FDA to have AMR101 certified for the treatment of high triglycerides. Triglycerides are fats in your blood. High levels indicate dangerous cardiac and stroke risks for many people. A decision by the FDA should be announced by mid July 2012 along with a decision on NCE (new chemical entity). Receiving an NCE certification is critical for longer patent protection.
Amarin feels confident in being granted an NCE status, as the FDA has also asked the company to do an outcome study costing up to $120 million and enrolling up to 8,000 patients. To quote Amarin CEO Zakrzewski: "To my knowledge, an outcome study has never been requested for a drug that didn't get NCE status." (Amarin CEO Seeks Redemption And Investors at JP Morgan Conference)
Amarin Corp had earlier filed a patent (#889) for the treatment of high triglycerides that was rejected by the patent office in August 2011, and the stock sold off eventually hitting a low of $5.99 on Dec 15, 2011. Amarin has since met with the Patent Office and resubmitted its 889 patent application that is now more narrowly focused on very high triglycerides and elevated ApoB.
With the help of noted biostatistican Dr Philip Lavin (formerly with the Harvard Medical School), Amarin was also able to demonstrate that the Patent Office examiner used the wrong statistical equations as a basis for his rejection. The Patent Office's decision on the resubmitted application is due by mid-March 2012.
This time I believe the patent will be granted and should be a major catalyst for the stock.
So if you follow AMRN you are now thinking, "So what, this is known by the market, tell me something new."
Well, what I think is missing most (except well informed message board posters such as Jesse Livermore - Yahoo AMRN message board) is the following: If approved, AMR101 will likely be prescribed to a far wider patient population then just those with high triglycerides.
If you are currently taking Niacin or Colestipol, and suffering side effects, you may want to consider AMR101. If you have a high hsCRP reading but otherwise fairly normal cholesterol reading, you may want to consider AMR 101. If you have high readings of the ApoB risk marker, and fairly normal reading of LDL cholesterol, you may want to consider AMR101. And of course, if you have high triglycerides, you will want to consider AMR101.
All of this can be achieved without raising LDL (in fact in 4g doses AMR101 lowers LDL by about 6% - something competing drugs such as Lovaza can not do). By the way, my doctor refuses to prescribe me Lovaza because he is concerned it may elevate my LDL.
In short, if you are taking a statin drug such as Lipitor and it's not quite getting all your cardiac or stroke indicator risks down to where they are no longer risks, you may want to consider AMR101. AMR101 has the potential to become the drug of choice for all patients with elevated cholesterol markers as well as those with high hsCRP values, and may, in fact, replace the use of Statins in some situations.
Statin drugs are believed to increase the risk of diabetes in addition to the other risks mentioned above (possible muscle cramps, memory loss and liver damage). None of these risks are believed to be present with AMR101.
The market size for statin drugs? In 2009 the world statin market generated over $27bn in revenues. (Statins: World Market Outlook 2011-2021)
Many have criticized the CEO of Amarin for not pursing a quick sell out to big Pharma companies like Pfizer (who have recently lost their patent protection covering Lipitor). But frankly, I don't think any big Pharma companies would be seriously interested without some serious patent protection.
Of course, all of that may well change within the next six months.
If Amarin gets the patent protection, FDA approval and NCE status the company is seeking - and although this is not certain, I think it is highly likely - then the company will become a force to be reckoned with in the field of cardiac and stroke risk management, and its stock price will likely be a lot higher.
Although my triglycerides are only moderately elevated, I will be first in line to dump my flush (Niacin) and fart (Colestipol) cholesterol-lowering medication for some easy to tolerate and highly effective AMR101. I don't think I will be the only one.
Dates to watch for:
Mid March - Patent decision on revised 899 application
Mid July - FDA and NCE decisions
Disclosure: I am long AMRN.