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  • AtheroNova, Amgen And More Leveraging Russian Initiatives To Grow Biotech Sector

    AtheroNova, Amgen and More Leveraging Russian Initiatives to Grow Biotech Sector

    "Life is short, and the process is long." That's what Cleveland BioLabs (NASDAQ: CBLI) President Dr. Michael Fonstein told Forbes last year while discussing the U.S. Food and Drug Administration's regulatory process. Cleveland BioLabs shifted the development of several of their drugs from the U.S. to Russia, the birthplace of the company and a land where regulations are more flexible, in order to expedite the process towards commercialization.

    In 2011, Cleveland BioLabs and Rusnano, a company and fund owned by the Russian government, partnered to start Panacela Labs, Inc. in collaboration with Roswell Park Cancer Institute, Children's Cancer Institute of Australia and Cleveland Clinic Foundation. Rusnano agreed to provide up to $26 million in funding over a four-year period to Panacela, which maintains operations in Buffalo, New York and Moscow, Russia. Cleveland BioLabs also has a 59-percent ownership in Incuron, LLC, another Russian Federation-based joint venture (with Russian closed mutual venture fund, Bioprocess Capital Ventures) conducting clinical trials in Russia.

    Russia has made no bones about its initiatives to command a larger portion of the global biotech market. In 2010, Russia only had a 0.2-percent market capture, but promises by now-President Vladimir Putin were meant to boost that to 5 percent by the end of the decade as part of The Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020.

    Retooling its biotech framework and dedicating funds, Russia has been encouraging Western companies to consider bringing their technology there. It seems to be working as the Ministry of Health approved 210 new clinical trials in the third quarter of 2013, up 59 percent compared to the year prior quarter, according to an orange paper by Synergy Research Group, a Russia-based contract research organization. Companies from 18 different countries were represented in those trials.

    Amongst those trials, Amgen, Inc. (NASDAQ: AMGN) sponsored seven of the new studies and Sanofi SA (NYSE: SNY) sponsored six. Janssen Pharma, a Johnson and Johnson (NYSE: JNJ) company, AstraZeneca PLC (NYSE: AZN) and GlaxoSmithKline plc (NYSE: GSK) applied for five new trials each.

    It's also interesting to note that nine of the 23 new drugs that were approved by the FDA's Center for Drug Evaluation and Research (CDER) during the third quarter were researched in clinical trials in Russia.

    Pfizer Inc.'s (NYSE: PFE) conducted part of its pivotal trial of Lyrica in Russia on the path to receiving FDA approval last June as a treatment for neuropathic pain associated with spinal cord injury.

    For any drug maker, financial support and trial ideology that expedites development, shaving years and potentially hundreds of millions of dollars of research, is certainly a benefit of trials in Russia. That is especially true for generally cash-strapped juniors that are now garnering significant support from Russian investors as well. AtheroNova Inc. (OTCBB: AHRO) has an agreement with OOO CardioNova, a Russian subsidiary of Maxwell Biotech Group owned jointly by the Russian Federation and private investors. The Maxwell Biotech Venture Fund, created with the participation of the Russian Venture Capital and managed by Russia's Maxwell Asset Management, is the first venture fund in Russia fully dedicated to investments in the life sciences sector.

    CardioNova has licensed territorial development and commercialization rights to AtheroNova's AHRO-001, a drug candidate for the treatment of atherosclerotic plaque. In May, the Russian Ministry of Health approved CardioNova to commence a Phase I clinical trial of AHRO-001, which subsequently began in June. The company is already planning for a Phase II trial in Russia in 2014, expecting that Phase I data is going to replicate lab studies showing strong safety, tolerability and pharmacokinetic profiles while lowering atheroma burden.

    The Maxwell Biotech Venture Fund has provided $900,000 in funding so far to CardioNova. CardioNova has become an equity investor in AtheroNova, making an initial purchase of up to $267,000.

    The confluence of global biotechs in Russia is likely to pay dividends for both the country and the individual biotechs leveraging the government initiatives. That's not to say that matriculating to Russia to conduct research doesn't present its own set of challenges, namely many investors in the States holding some bias for studies conducted outside U.S. borders. However, reliability and validation as to the completeness and caliber of research that dovetails with U.S. regulations has grown tremendously in recent years and looks to be gaining steam with majors and juniors alike realizing the benefits, much to the ultimate benefit of the patient population worldwide.

    Disclosure: I am long OTCQB:AHRO.

    Tags: JNJ, MRK, PFE, AMGN, SNY
    Jul 17 12:25 PM | Link | Comment!
  • AtheroNova's AHRO-001 Targets Much More Than Cholesterol, Shows New UCLA Study

    AtheroNova's AHRO-001 Targets Much More than Cholesterol, Shows New UCLA Study

    Metabolic Syndrome ("MS") affects approximately a quarter of the U.S. population, according to a 2002 National Health and Nutrition Examination Survey. Characterized by raised triglycerides, reduced HDL cholesterol, high BMI/waistline, raised blood pressure, and raised fasting plasma glucose, the syndrome significantly increases the risk of heart disease and a host of other health problems, including stroke, diabetes and some common forms of cancer.

    Savvy readers may be surprised that LDL cholesterol is absent from the list, despite the fact that the media has demonized cholesterol. Meanwhile, companies like Pfizer Inc. (NYSE: PFE), Merck & Co. (NYSE: MRK) and AstraZeneca plc (NYSE: AZN) have all built multi-billion dollar statin drugs designed specifically to reduce LDL cholesterol. In reality, a broader approach may be necessary and these statins may need to be supplemented with additional drugs.

    While statins produced by these companies have been shown to modestly raise HDL cholesterol levels, investors may want to take a look at a newer company with a compound that has the potential to address multiple aspects of Metabolic Syndrome. AtheroNova Inc.'s (OTCQB: AHRO) AHRO-001 uses natural bile salts to reduce atherosclerosis by lowering fasting plasma glucose levels, reducing cholesterol absorption, and improving HDL cholesterol function.

    Taking a Wholesome Approach

    AtheroNova recently announced preclinical study results outlining the potential of AHRO-001 in the FASEB Journal - one of the world's most cited biology journals. The pre-clinical study, entitled Hyodeoxycholic acid improves HDL function and inhibits atherosclerotic lesion formation in LDLR-knockout mice - examined the effects of AHRO-001's active ingredient - hyodeoxycholic acid - on lipid metabolism and atherosclerosis in LDL redceptor-null ("LDLRKO") lab mice.

    According to the study's abstract:

    We observed that mice fed the [hyodeoxycholic acid] diet were leaner and exhibited a 37% (P<0.05) decrease in fasting plasma glucose level. HDCA supplementation significantly decreased atherosclerotic lesion size at the aortic root region, the entire aorta, and the innominate artery by 44% (P<0.0001), 48%, (P<0.01), and 94% (P<0.01), respectively … Plasma VLDL/IDL/LDL cholesterol levels were significantly decreased, by 61% (P<0.05) … HDCA supplementation decreased intestinal cholesterol absorption by 76% (P<0.0001) … HDL isolated from the HDCA group exhibited significantly increased ability to mediate cholesterol efflux ex vivo.

    The key points in this excerpt are the fact that fasting glucose levels were significantly reduced and HDL cholesterol function improved - addressing two key factors in Metabolic Syndrome. Moreover, the results section of the study highlights the fact that the HDCA mice had a 10% lower bodyweight, significantly decreased fat mass, and increased lean mass, which are other positive results with regards to BMI and waistline components of Metabolic Syndrome.

    While LDL cholesterol levels were also significantly lowered, the reduction in atherosclerotic lesion size is arguably far more important and demonstrates AHRO-001's efficacy in reducing the key problem rather than a potentially contributing factor. This may make the compound a great addition to other drugs on the market, if similar results can be replicated in humans, while addressing a larger number of potential end markets for Metabolic Disease.

    Looking at the Road Ahead

    The positive pre-clinical results above represent a significant step forward for AtheroNova and its investors, demonstrating the safety and efficacy of AHRO-001 in mouse models. As we've explored, the compound appears to address many of the underlying causes of Metabolic Syndrome instead of focusing on just one component, which could make it more effective in treating heart disease, while opening the door to many other indications.

    On June 25, 2013, the company announced the initiation of a Phase I clinical trial with AHRO-001 that will evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers. The study is being conducted in Russia with its licensing partner, OOO CardioNova, and will be a randomized, double-blind, placebo controlled study that uses ascending doses. Results from the Phase I study are expected to come later this year with a Phase II starting at the same time.

    "Based on AHRO-001's preclinical profile, we believe it has the potential to offer patients effective treatment for these chronic conditions with an improved therapeutic profile," said Chairman and CEO Thomas W. Gardner in a recent press release announcing the Phase I trial. "We look forward to assessing AHRO-001 in human trials and are extremely pleased to have met a signification milestone with transitioning into a clinical stage company."

    Investors interested in companies targeting Metabolic Syndrome, from Arena Pharmaceuticals Inc. (NASDAQ: ARNA) to VIVUS Inc. (NASDAQ: VVUS), may want to consider taking a position in AtheroNova as these clinical trials progress and additional data becomes available. While additional trials are necessary before an approved drug, there are many pre-clinical positive indications and major pharmaceutical giants are likely already watching closely.

    For more information, please see atheronova.com or read the complete pre-clinical study at the following URL: http://www.fasebj.org/content/early/2013/06/10/fj.12-223008.short. Investors can also watch the company's virtual 2013 annual meeting online at https://central.virtualshareholdermeeting.com/vsm/web.do?pvskey=AHRO.

    Disclosure: I am long OTCQB:AHRO.

    Tags: PFE
    Jul 01 4:54 PM | Link | 1 Comment
  • AtheroNova: (AHRO): Finding The Next Big Blockbuster Statin Drug

    AtheroNova: (OTCQB:AHRO): Finding the Next Big Blockbuster Drug

    The pharmaceutical industry is largely centered on blockbuster drugs, with the top 20 drugs in the U.S. accounting for nearly $320 billion in sales in 2011. With five of those 20 drugs losing patent protection since then, there has been a high premium placed on finding the next big blockbuster drug on the part of companies and investors in the pharmaceutical industry. [1]

    Not surprisingly, the most lucrative classes of drugs were those targeting heart disease, which was the leading cause of death in 2011, according to data from the CDC. Some of these blockbusters included Pfizer Inc.'s (NYSE: PFE) Lipitor® that generated $7.7 billion and Bristol-Myers Squibb (NYSE: BMS) and Sanofi SA's (NYSE: SNY) Plavix® that generated $6.8 billion. [2]

    So, how can investors find the next blockbuster drug?

    Looking at Pfizer's Lipitor® for Clues

    Pfizer's Lipitor® is a statin that works by blocking the enzyme HMG-CoA reductase in the liver in order to lower LDL cholesterol levels. The idea for a statin didn't come from Pfizer - far from it. Dr. Akira Endo discovered statins working for a small Tokyo drug company called Sankyo in 1971 after spending years searching through more than 6,000 microbes for an HMG-CoA inhibitor. [3]

    After Dr. Endo discovered mevastatin, word of the breakthrough quickly spread throughout the medical community. Merck & Co. (NYSE: MRK) began immediately searching in the same class and found lovastatin, another statin that proved to be very effective in lower LDL cholesterol levels, and eventually developed Mevacor® that became the first U.S. statin. [3]

    Warner-Lambert soon discovered its own statin - atorvastatin - that proved more effective than Mevacor® in lowering LDL cholesterol. But with Mevacor® already in its final rounds of clinical trials at the time, the company needed to move quickly and partnered with Pfizer. The two used existing statins as comparisons, while keeping its own secret, giving it a key advantage. [3]

    Eventually, Pfizer and Warner-Lambert launched their drug Lipitor® onto the market and it went on to generate some $7.7 billion in sales and become the best selling drug of all time. The important takeaway is that it wasn't a new concept and many customers still weren't familiar with LDL cholesterol's role initially, but the drug still became enormously successful. [3]

    Atherosclerosis is the Next Big Target

    AtheroNova Inc. (OTCQB: AHRO) is taking a new approach in treating atherosclerotic plaque that doesn't involve simply targeting LDL cholesterol levels. The company's lead AHRO-001 compound uses naturally occurring compounds normally found in the digestive tract to dissolve soft or vulnerable plaque via a multi-prong approach that could complement statins. [4]

    Early pre-clinical trials of AHRO-001 at UCLA and Cedars-Sinai were promising, showing a 95% reduction in innominate arterial plaque formation versus the control group with no adverse side effects observed in the study group. Moreover, Ursodiol is based on the same active ingredient and has already been approved by the FDA for the treatment of gallstones and biliary cirrhosis. [4]

    Like Pfizer's Lipitor®, AtheroNova's AHRO-001 isn't based on a new concept, but rather research that has been done for some time. Bile salts are a naturally occurring compound and have been extensively studied for many uses, but it wasn't until recently that they were discovered as important modifiers of lipid and energy metabolism. [5]

    AtheroNova also holds several key patents on the technology, including U.S. Patent 8,304,383 that covers the use of hyodeoxycholic acid for atherosclerotic plaque lesions. These patents support the development of AHRO-001, as its partner CardioNova pursues similar intellectual property, on behalf of AtheroNova, to protect the assets in the Eurasian markets. [7]

    Potential New Class of Drugs

    AtheroNova's focus on bile salts represents a new potential class of drugs that could complement the $20 billion per year market for statins. By targeting the root cause of atherosclerosis, the company's approach could add efficacy to the existing approach targeting LDL cholesterol, which may not be effective enough on its own, according to some studies. [6]

    Capturing even 1% of the statin market represents a $2 billion per year opportunity for the $20 million public company, putting AHRO-001 squarely in the blockbuster drug category. Like Warner-Lambert when it stumbled upon atorvastatin, AtheroNova could also partner with a larger drug company like Pfizer or Merck to bring the drug to market.

    In the end, there's little question that AtheroNova's AHRO-001 has blockbuster drug potential, if it's able to progress through clinical trials. There are also many positive early signs for AHRO-001, including an established safety profile and strong efficacy results. As a result, this is one speculative biotech play that investors may want to keep a close eye on moving forward.

    Sources

    1. http://www.businessinsider.com/10-best-selling-blockbuster-drugs-2012-6?op=1
    2. http://www.cdc.gov/nchs/fastats/lcod.htm
    3. http://money.cnn.com/magazines/fortune/fortune_archive/2003/01/20/335643/
    4. http://biotechstocktrader.com/new-ways-to-target-atherosclerosis/
    5. http://atvb.ahajournals.org/content/30/8/1519.full.pdf
    6. http://www.prnewswire.com/news-releases/statins-market-to-2018---weak-product-pipeline-and-shift-of-focus-towards-combination-therapies-will-lead-to-erosion-of-brand-share-188700321.html
    7. http://www.atheronova.com/media-center/company-news?detail=3

    DISCLAIMER: I am long shares of AHRO and am hoping it goes to $40.00.

    Disclosure: I am long OTCQB:AHRO.

    Tags: PFE, BMS, SNY, Lipitor, Plavix
    Jun 21 11:40 AM | Link | 1 Comment
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