The potential of both these technologies to deliver breakthroughs in fight against some of the worst diseases plaguing humanity today is immeasurable. The CNS disorders market is already one of the biggest, valued at more than US$98 billion per annum with an 8% annual growth. Yet many of the CNS diseases cannot be treated either due to lack of a suitable diagnosis method or due to inability of 95% of drugs to cross the BBB.

 

Diagnosing Alzheimer's Disease

 

AD is one of the most cruel and costliest diseases plaguing our society today. This incurable, degenerative, and fatal disease is affecting roughly 30 million people worldwide, 5.3 million of them in the US. With an aging population this number is expected to double every 20 years.

 

Based on the recently released World Alzheimer Report 2010: The Global Economic Impact of Dementia the total societal cost of AD in 2010 is estimated at $360 billion. That is almost as high as the 2009 GDP of the oil producing giant - Saudi Arabia.

 

Not only is there no cure for AD, there isn't even a reliable test for diagnosing it. Even today, the only definitive diagnosis can be reached after the patient dies and the brain is examined for plaques and tangles, two of the main features of AD.

 

After decades of research and over 500 clinical trials we don't have a drug to halt or even delay progression of the disease. Lack of simple test is a major obstacle, so much so that this summer a New York Times article praised as revolutionary the new opportunities to diagnose the disease with the aid of MRIs, brain scans, and spinal taps. These methods are costly and time consuming making them impractical.

 

Bioasis' Cognitest™

 

Bioasis Technologies' Cognitest is a simple blood test for AD. After years of development and several successful proof of concept studies, the commercial version of the product is in the final stages of development in collaboration with the UK-based Fleet BioProcessing. Bioasis expects to gain European Union regulatory approval in early 2011.

 

Validating study will be an important indicator of how effective Cognitest will be. Data from the independent study suggests that the test will be very accurate for AD patients at the possible and probable stages of the disease. This is vitally important in diagnosing AD versus other forms of dementia, something most clinicians struggle with on a daily basis.

 

Where the test can make a drastic impact is if it can detect AD before any symptoms of the disease become obvious. Benefits of this are that people who know they will be developing AD in a few years time can try preventive therapies such as Vitamin B12 injections and enrollment in AD clinical trials.

 

By continuously using Cognitest researchers can monitor the progress of the disease and quickly determine what drugs are effective in preventing, and even reversing AD.

 

Crossing the Blood Brain Barrier

The World Health Organization has identified CNS disorders as the major medical challenge of the 21st Century. Despite the large market segment, most CNS disorders do not have an adequate treatment today. This is due to the complexity of the brain and the BBB.

 

The blood brain barrier acts as a protector of the CNS by separating circulating blood and cerebrospinal fluid in the CNS. While effectively protecting the brain from many common bacteria and infections, the BBB also severely limits the movement of potential medicines into the brain.

 

In addition to preventing treatment of the diseases, the BBB also impacts the way many drugs are administered today. Morphine and general anesthetic are examples of drugs that can cause problems because in order to get miniscule amounts of drugs into the CNS, large and potentially harmful quantities of drug need to be given to patients. Patients with multiple health issues often cannot undergo surgeries due to these risks.

 

Bioasis' Transcend™

 

Transcend is a carrier for delivery of therapeutic agents across the BBB. It is based on p97, a naturally occurring protein that is able to cross the BBB. Studies have shown that Transcend is capable of delivering a range of different molecules across the BBB and accumulating the same in the brain parenchyma.

 

In one p97 study, researchers tested delivery of Andriamycin, a chemo drug used to treat several cancers and leukemia, across the BBB in combination with p97. Presently Andriamycin cannot be used to treat brain cancer because of cardio-toxic side effects. In combination with p97, researchers were able to deliver therapeutic levels of Andriamycin to the brain with no cardio-toxic side effects.

 

There are several companies developing BBB delivery technologies at various stages of development and varying degree of success. The closest competitor to Transcend would be privately held to-BBB's G-Technology which is also in pre-clinical stages of development. In comparison, G-Technology appears inferior because it seems limited to transport of small molecule drugs. G-Technology is also a liposome based vehicle which may indicate a complex manufacturing process, particularly in terms of scale up and mass production. Despite these limitation, to-BBB has already signed over a dozen partnerships to investigate the practicality of using G-Technology in CNS therapies such as brain cancer, stroke, etc...

 

Transcend's ability to transport a wide range of drugs across the BBB is of interest to every major pharmaceutical company, as well as to a number of mid-size CNS specialty companies such as Lundbeck.

 

The company has already initiated internal development programs with a select target of drug candidates. Results from these programs should be available in 2011.

 

Since May of 2009, Bioasis has collaborated on a Materials Transfer Agreement with a major US biotech company for Transcend. It is expected that there will be an update on this MTA by Q1 of 2011. In all probability the trial will be a success since it is unlikely that it would take more than 18 months to receive negative news.

 

The Company

 

Bioasis Technologies (BTI.V) is led by a proven team of business and science leaders. The CEO and Chairman, Rob Hutchison, is the former founder of the eCharge Corportaion. He has extensive experience in the development and commercialization of technologies. Most other management and board members are well respected leaders who come from successful past ventures. Special adviser to the company, Mr. Godsy had his ID Biomedical bought out for $1.4B. Hugh MacNaught and Dr. Fibiger are both highly respected in the life sciences sector.

 

The company has roughly 28M shares out with the market cap of $13.8M. Officers, directors and insiders hold roughly 35% of the outstanding shares, while a Zurich fund holds an additional 3 million shares.

 

Since its formation in 2007, Bioasis has steadily advanced development of its two main programs: Cognitest, and Transcend. The company is now focusing on commercialization of these products.

 

The Opportunity

 

It is rare to see such an incredible potential in any market. Bioasis is now in the final stretch towards commercialization where, within a few months, several key developments will shape this company's future.

 

Cognitest may soon become a household name with Bioasis featured on Dr. Oz's show with their ground-breaking achievement.

 

Cognitest would be out-licensed, potentially generating tens of millions of dollars in annual royalties.

 

Transcend is targeting one of the most lucrative pharmaceutical market segments where the top 10 CNS drugs have revenues between $2B-$5B per annum. Transcend can enhance the performance of existing drugs, but also assist in the development and provision of new medicines for disorders such as Alzheimer's, Parkinson's, multiple sclerosis, schizophrenia, cancer, etc.

 

The company's plan is to quickly generate revenues from Transcend by focusing on enhancing approved drugs that are off patent, or ending patent protection. By coupling Transcend with drugs that are approved for use in humans, the company will significantly reduce risks of clinical trial failures. Pharmaceutical companies will be motivated to partner with Bioasis because combining approved drugs with Transcend will extend the patent protection, thereby protecting future revenues.

Transcend can very quickly bring in initial payments, followed by milestone payments and finally royalties in excess of 100s of millions of dollars. A single $2B CNS drug could result in royalties of $200M per annum.

 

I love investing in well managed, early stage companies with huge upside potential. Bioasis is one such company. With only 28M shares out, an experienced management team with plenty of skin in the game, and two ground-breaking products, I believe Bioasis Technologies has the potential to be a ten bagger within the next 12-18 months.

 

TB

TechnicalBuy.com