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Targeted Medical Pharma, Inc. (OTCQB: TRGM) (OTCBB: TRGM) |
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December 10, 2012 Issue |
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The Most Powerful Name In Corporate News and Information |
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Focusing on RX only Foods and entering Disease States where Big Pharma has not been successful in generating new products has given Targeted Medical Pharma Inc. an Edge in the Growing Area of Medical Foods |
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Targeted Medical Pharma,
Inc. is a specialty pharmaceutical company that
develops and sells prescription
medical foods to physicians and pharmacies for the treatment of chronic
disease, including pain syndromes, obesity, sleep and cognitive disorders.
The company manufactures ten proprietary prescription-only medical foods, as
well as 48 convenience packed kits, which pair a medical food and
branded or generic pharmaceutical. These
prescription medical foods and therapeutic systems represent a novel
approach to the management of certain disease states, focusing on safety and
efficacy without the deleterious side effects of traditional, high dose
prescription drugs. Based in Los Angeles, the company’s proprietary
pharmaceutical therapeutic systems are currently sold in the United States
and the Middle East. Targeted Medical Pharma also provides billing and
collection services on behalf of dispensing physicians. William Shell M.D. is Board Member, CEO, and Chief Scientific Officer. Dr. Shell is a board certified cardiologist and inventor possessing multiple United States patents. Dr. Shell attended the University of Michigan Medical School and graduated in June 1967. Dr. Shell was one of the first students chosen by the Michigan Heart Association to train in the cardiovascular division of University Hospital of University of Michigan. He published the first American paper on the syndrome now known as Mitral Valve Prolapse, which demonstrated the genetic nature of this malady. Following his residency at the University of Michigan, Dr. Shell began a National Institutes of Health (NIH) Special Fellowship to study cardiology under Dr. Eugene Braunwald at the University of California San Diego. During his fellowship, Dr. Shell was a member of the team credited with discovering the cardio specific enzyme CK-MB. A diagnostic test for the presence of the CK-MB enzyme is now the clinical foundation for the detection and treatment of heart attacks. Dr. Shell and his colleagues published a total of 44 papers in medical journals on this body of work between 1969 and 1974.
Dr. Shell joined the United States Air Force following his fellowship. The first months of his military service were spent in the American Soviet Exchange Program as the first American physician representing the National Institutes of Health and the American government in Moscow. Several publications emanated from Dr. Shell's work in the Soviet Union, including early biochemical work that defined the relationship between heart cell growth and creatine. In addition, he and his Soviet colleagues performed clinical trials which led to the discontinuation of digitalis as a treatment of heart attacks. These studies lead to the early examination of reperfusion as part of the treatment of heart attacks. Upon his return to the United States, Dr. Shell served an as the director of the coronary care unit at Keesler Air Force Base in Mississippi, where he supervised the construction of the first modern coronary care unit for the United States Air Force, which became the model for future units. Dr. Shell was awarded a Presidential Citation by President Richard Nixon for his work in the American Soviet Exchange Program and his administrative work creating the coronary care unit at Keesler.
Following his discharge from the Air Force, Dr. Shell returned to Los Angeles and joined the cardiology staff at Cedars of Lebanon Hospital and Mount Sinai Hospital. During his tenure, he planned, directed and implemented the merger of the coronary care unit at Cedars of Lebanon and Mount Sinai Hospital to what is now known as Cedars-Sinai Medical Center in Los Angeles, California. Dr. Shell was also Director of the Cardiac Catheterization Laboratory and Director of Cardiac Rehabilitation. In addition, he participated in the planning, funding and administration of NIH grants and managed a biochemistry research laboratory at Cedars-Sinai Medical Center. Dr. Shell also was given teaching responsibilities at both Cedars-Sinai and the University of California at Los Angeles, where he obtained the title of Associate Professor of Medicine in Residence.
In 1989, Dr. Shell, along with Ms. Elizabeth Charuvastra, founded Beverly Glen Medical Systems, a cardiac diagnostic service company. Dr. Shell served as the chief scientific officer and chief medical officer. The technology that was developed at this company resulted in two patents that allow for the measurement of autonomic nervous system activity and measurements of the QT interval on 24-hour electrocardiograms. The technology has been used by the pharmaceutical industry in establishing safety standards for new drugs, by the Veterans Administration to establish that the Gulf War Syndrome is a form of nervous system dysfunction and by the Environmental Protection Agency and other environmental groups to examine the effects of environmental toxins on the brain and other parts of the autonomic nervous system.
In 1991, Dr. Shell founded and served as chairman and chief executive officer of SeeShell Biotechnology, which merged with a company called Interactive Principals, which in turn merged into Interactive Medical Technologies, Inc. (IMT), whose stock was quoted on the Over the Counter Bulletin Board. Dr. Shell relinquished the daily CEO role and retained the title of Chairman of the Board of Directors until 1995. Dr. Shell is the author of more than 150 scientific articles published in peer-reviewed journals. |
Specialty Pharmaceuticals
Targeted Medical Pharma, Inc. |
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Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – December 10, 2012
Dr. Shell: Targeted Medical Pharma is a specialty pharmaceutical company that develops nutrient based pharmaceuticals and distributes both conventional pharmaceuticals and nutrient based pharmaceuticals.
CEOCFO: What are nutrient based pharmaceuticals and why do we need them? Dr. Shell: Nutrient based pharmaceuticals use various generally recognized as safe and effective nutrients to elicit pharmaceutical responses. For example, most of our products are based on amino acids, which are converted to neurotransmitters and they elicit pharmaceutical-like responses. Another example would be that it can activate the autonomic nervous system to induce sleep, manage pain and deal with cognitive function without single molecule pharmaceuticals that elicit side effects.
CEOCFO: What are some of the circumstances where this use would be preferable? Dr. Shell: The first medical foods were introduced in the 1850s and were the first regulatory category that involves breast food supplements so that the baby formulas were originally medical food and have been regulated as medical foods until about thirty years ago where they are now regulated as foods for a special dietary need. Medical foods are much more prevalent than most people believe. Many of the large pharmaceutical companies manufacture medical foods. For example, Ensure was originally manufactured as a medical food. The markets are reasonably large for this class of medications.
CEOCFO: What is the competitive landscape, and are many companies doing what you do, or something similar? Dr. Shell: Medical foods are sold by Nestle, Abbott and Mead Johnson, so it is prevalent. Our medical foods are RX only, meaning they can only be prescribed by a physician. In conventional medical foods, they do not have an RX only but they still require ongoing physician supervision, so they are often behind the counter and not over the counter like dietary supplements and pharmacists track to make sure that the patients are followed by physicians because of the nature of the regulatory response.
CEOCFO: What are some of the products where you specialize; why should people use your brand? Dr. Shell: The most significant product that we sell at this time is a pain medication called Theramine that is largely free of side effects. There have been more than 38 million individual administrations of Theramine without a single death or intestinal hemorrhage or hospitalization, which are frequently seen with non steroidal anti-inflammatory agents. We have a far reduced incidence of side effects. For example, we can substitute for narcotic analgesics and there is not addictive potential of our therapy. There is a rising incidence of narcotic addiction to treat mild to moderate pain. Our products are as effective as non-steroidal and most of the narcotic medications. A Doctor can use Theramine as an adjunct to a low dose narcotic without compromising efficacy of treatment, and limiting the side effects of the narcotic.
CEOCFO: Are most physicians aware, and why are people relying on drugs with options like yours? Dr. Shell: The answer is these things have only been developed in the last ten years. Our products have been on the market in 2006 and therefore we have been growing at a significant rate. As we build out across the country, we first have to teach physicians and then we have to teach patients that a safe and potentially more effective alternative to more harmful medications are available.
CEOCFO: How do you accomplish educating the medical community and the public? Dr. Shell: We accomplish this through a series of educational and marketing campaigns. We use social media like Facebook, Youtube, Twitter, and Linkedin to reach our target audiences, in addition to the more traditional trade publications like Pain Medicine News. We host quarterly educational webinars along with exhibiting at numerous tradeshows and conferences on an annual basis. There is also significant word-of-mouth education, which is surprising. Patients tell other patients, physicians tell other physicians and we have not had to do any significant direct to patient advertising.
CEOCFO: What have you figured out to put these pieces together that perhaps of which others are not aware? Dr. Shell: I have been inventing products since I was in my late twenties. I have a significant number of patents. The essence of the process is that it has been well known for many years that amino acids become brain messengers and neurotransmitters, so that is not new. The problem is we used to have gram quantities for what is a low milligram concentration needed to elicit these responses. We have evolved beginning in 1995 to 2003, a process where we can get these amino acids to cells and then we can convert them from the amino acids to the neurotransmitters and then elicit a response at low-dose concentrations of these amino acids. The last step did not occur until 2003 when we learned how to prevent the attenuation or tolerance using a certain polyphenol so they keep working for years rather than lose their effectiveness over time. The insight occurred through revealing the literature, producing prototypes, testing the prototypes and having a statistically accurate testing methodology.
CEOCFO: What are some of the other products that you are either working on or have available today? Dr. Shell: Besides the pain medication Theramine, we have products that induce sleep and avoid grogginess. We have a product for cognitive function that produces acetylcholine, which is the key molecule in memory and thought process. For example, the sleep products are called Sentra PM® and GABAdone®. One deals with sleep disorders associated with anxiety and the other deals with sleep disorders associated with depression. Sentra AM® is designed for the dietary management of cognitive disorders. We are currently completing a clinical trial testing change in cognitive function within nursing homes. We have a product that is designed to deal with metabolic syndrome and Obesity called AppTrim® and it is designed to modulate appetite and metabolic syndrome. Those are our primary products on the market. We do have a product for high blood pressure called Hypertensa® and we have a product for peripheral neuropathy called Percura™. Those are our primary products. We have products in development that deal with mild to moderate anemia, one to for nasal congestion and allergies and one for infections.
CEOCFO: How do you decide the order of your projects? Dr. Shell: We have attempted to deal with niches that have not been satisfied by conventional pharmaceuticals. We targeted disease states where there is not good therapy at this point. Therefore, we are not trying to move into the niches of big pharma; we see it ourselves as entering disease states where big pharma has not been successful in generating new products. We then look at those disease states where we have a measurement tool to assess that the products are working. That is the basis of how we decide our clinical trials. We know that the physiologic effect is elicited by the products that are measurable. We know that the products work before entering clinical trials. We do double blind clinical trials but our number of patients and so-called power is reduced substantially because our products have ingredients that are generally recognized as safe. The FDA does not require preapproval for our products, so we truncate a large amount of the expense that traditional single-molecule pharmaceuticals must go through because we are safe. We maintain a hotline for the FDA and we have only had one complaint since 2006, which in that case the patient was taking another medication that we believe were responsible for the symptoms. We have a remarkably reduced cost of market price but we have to be very careful that we have appropriate clinical trials. We have never developed a cholesterol product or a cancer product because we would not target those states at this point because by targeting disease states without significant treatment options, we think we can make a major contribution.
CEOCFO: Are these items reimbursable? Dr. Shell: Our products are reimbursable. We are reimbursed by private insurance and by worker’s compensation plans and we are reimbursed for several Medicare type plans like the Advantage plans.
CEOCFO: Have you considered going directly to the public? Dr. Shell: We considered that. Because of our RX only, we think these things directly should be administered by physicians and we do not want to stimulate false expectations at this point by direct-to-consumer advertising. We could not handle that volume. The direct-to-consumer marketing is on our agenda and we will approach that marketing with a product that is under development for nasal decongestion.
CEOCFO: Development and commercialization is always a costly matter; is Targeted Medical Pharma funded for the next steps of growth? Dr. Shell: We are essentially self-funded. We have two angel investors. The company is now at cash flow neutrality, so we are not burning any cash. We are seeking funding to expand our marketing and sales base.
CEOCFO: What have you learned in your past endeavors that could be most applicable in this venture? Dr. Shell: If this was easy, everybody would do it and the treatment processes of the pharmaceutical industry is at a plateau because of the increasing side effects of single-dose molecules and the paradigm has to change. We will not be able to develop new systems based on the single-dose molecules. It is too expensive, too many side effects and not able to create treatments without enormous investments.
CEOCFO: Why should the business and investment community pay attention to Targeted Medical Pharma?
Dr. Shell:
It is a new paradigm. It has enormous growth potential. It is attacking the
treatment of diseases with large potential markets without high development
costs, and will get to market years before new ventures on pharmaceuticals
and with far less development cost. |
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“We have attempted to deal with niches that have not been satisfied by conventional pharmaceuticals. We targeted disease states where there is not good therapy at this point. Therefore, we are not trying to move into the niches of big pharma, we see it ourselves as entering disease states where big pharma has not been successful in generating new products.”- William Shell M.D. |
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