AHRO: Don't miss a $41 Billion Opp! Great article.
Combining Therapies to Amplify the Effects of Statins
Statins, drugs that improve blood cholesterol levels by inhibiting the liver enzyme HMG Co-A reductase, are some of the most widely prescribed drugs in the United States. Increasing diabetes and obesity rates are real problem, resulting in doctors working the script pad like never before in the last decade. Three of the 20 best-selling drugs of all-time are statins used in the treatment of dyslipidemia, a condition where a person has an abnormally high amount of lipids (cholesterol or fat) in their blood.
Pfizer, Inc.’s (NYSE: PFE) blockbuster Lipitor sits atop the list with $13.7 billion in sales in 2006. Also amongst the biggest ever are AstraZeneca’s (NYSE: AZN) Crestor, which did $7.02 billion in sales in 2011; and Merck & Co.’s (NYSE: MRK) Zocor, which generated $5.45 billion in sales in 2002.
Sadly, results from a massive, multi-year study by Quest Diagnostics released just last month in PLOS ONE showed that LDL, or “bad” cholesterol, levels stopped declining in Americans in 2008. In the words of investigator Robert Superko, M.D., medical director, cardiovascular disease, Quest Diagnostics, "The unprecedented scale of our data set should spur additional research to identify the cause or causes in order to prevent a possible reversal in years of gains in cardiovascular health in the U.S. population."
Accumulation of fatty materials, such as cholesterol and triglycerides, on artery walls leads to thickening of the artery, called atherosclerosis. The second best-selling drug of all-time is AbbVie’s (NYSE: ABBV) biologic Humira, a drug for artherosclerosis that recorded $9.27 billion in sales last year. Humira sales in the first quarter of 2013 improved 16 percent compared to Q1 2012 to $2.2 billion.
Combining statins or biologics like Humira with other therapies may be the next wave in battling cholesterol and coronary artery diseases. AstraZeneca was back in the news on May 28, disclosing that it would pay up to $443 million to acquire Omthera Pharmaceuticals (NASDAQ: OMTH) to gain control of Epanova, Omthera’s novel omega-3 free fatty acid composition drug candidate for the treatment of very high triglycerides. AstraZeneca intends to initiate a large-scale trial evaluating cardiovascular outcomes combining Epanova with Crestor.
The month earlier, AstraZeneca bought AlphaCore Pharma to grab its early-stage drug ACP-501 for management of HDL cholesterol.
This type of bolt-on business model may also pave the way other majors as they look to preserve patents on blockbuster drugs through a combination approach.
It also highlights unique juniors in the space like AtheroNova Inc. (OTCBB: AHRO) and what they have to offer as a stand-alone therapy or complement to statins with their research in regressing atherosclerotic plaque and improving lipid profiles. The rubber is about to meet the road for AtheroNova as its licensing partner, CardioNova, has recently received protocol approval from the Russian Ministry of Healthcare, meaning that a Phase I trial of AHRO-001 should be commencing in the near term. AtheroNova’s press release from last Thursday states that the drug product has been shipped to CardioNova, representing the last major step prior to initiation of the trial. The first patient dosing is expected in mid-to-late June.
AHRO-001 is a novel drug candidate that utilizes compounds naturally occurring in the liver for the process of delipidization to dissolve plaque in artery walls. AtheroNova’s compound has been shown in laboratory research to dissolve plaque deposits into molecules small enough to pass through the fibrous cap where it can be then be removed by the body through natural processes.
The power of statins is well documented to not only lower LDL levels, but also provide other benefits of potential plaque reversal and demonstrating an atheroprotective effect. They are also shown to modestly improve HDL, or “good” cholesterol, levels and reducing the size of plaque in arteries to a small extent.
AtheroNova believes that the mechanism of actions in AHRO-001 not only deliver similar results as statins, but also are involved in emulsifying plaque, upregulating ABCA1/ABCG1 gene expression, decreasing cholesterol absorption, stimulating reverse cholesterol transport and boosting HDL to a higher degree.
While AHRO-001 has the potential to provide a therapeutic benefit on its own as a first-in-class application for treatment and prevention of atherosclerosis, the possibility of serving as an adjunct to amplify the benefits of blockbuster statins may serve a great many purposes in the future as well. Clinical research will help bring the scenario further to light and a multi-prong approach is what helps build valuations in small biotech as it proves its contentions, especially in such a high profile area as coronary artery disease.