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August 24, 2015 Issue

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Rx branded Prescription Folate Deficiency Products for Hyperhomocysteinemia and related Neurological Disorders

 

 

Towny Robinson

CEO

 

JayMac Pharmaceuticals, LLC

www.EnLyteRX.com

  

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – August 24, 2015

 

CEOCFO: Mr. Robinson, what is the focus at JayMac Pharmaceuticals today?

Mr. Robinson: The primary focus of JayMac Pharmaceuticals is to bring new and exciting nutraceutical, pharmaceutical, Rx branded products to the market in the United States. Our products EnLyte and EnBrace HR™ are the only Rx branded folate deficiency products on the market for hyperhomocysteinemia and related disorders. The market is crowded with regard to supplements over-the-counter and medical foods, but not as Rx branded products in the United States.

 

CEOCFO: Would you tell us about your EnLyte product?

Mr. Robinson: EnLyte is a once a day gelcap, branded Rx pharmaceutical product, containing L-methylfolate magnesium, active coenzymes, cofactors, and a unique omega 3 for folate deficiency. Many people in the United States, for one reason or another, have deficiencies in folates, whether it is caused by genetic defects or environmental issues, and EnLyte restores those folate levels and addresses the disease states that causes.

 

CEOCFO: What are folates?

Mr. Robinson: Folates are actually B vitamin products. The folates that we have are the body/brain ready metabolites of B9 products, which are the products that can be used in the body to produce neurotransmitters and can help with neurological disease, such as depression or other related neurological disorders.

 

CEOCFO: What are the indications for your EnLyte product?

Mr. Robinson: Our EnLyte product is indicated for folate deficiency and it is associated with what is called hyperhomocysteinemia and related disorders. This condition occurs in age related dementia disease, cardio vascular disease, neurological disease, such as depression, schizophrenia, and anxiety syndrome.

 

CEOCFO: Given the large potential user base for your product, does the medical community realize that folates can help?

Mr. Robinson: The full value of folates is just beginning to be realized by the total medical community.  In the psychiatric community, the current American Psychiatric Association approved algorithm for Major Depressive Disorder includes folates as an adjunctive choice with SSRIs and SNRIs, for Major Depressive Disorder. It has been proven in many clinical studies and in recommendations to increase remission rates dramatically without increasing side effects. It is already being used in this area and it is also being used in other areas, such as in Alzheimer’s disease and Diabetic Neuropathy. It just so happens that our EnLyte product has also be used in monotherapy for patients that express this genetic effect called MTHFR polymorphism, which is getting more and more publicity. Polymorphisms reduce the body’s ability to break down food folate or folic acid into the endpoint metabolite that is needed to produce neurotransmitters. About 60% of the US population has this genetic defect. This condition puts people at risk along with psychological or physical stress for psychiatric pathology. Our product EnLyte contains the end point metabolite, L-methylfolate magnesium, that people with this genetic defect cannot produce adequately, so that it bypasses that genetic defect and helps them normalize production of neurotransmitters, reduce homocysteine, and produce glutathione addressing normal brain health.

 

CEOCFO: Are there any potential side effects?

Mr. Robinson: Actually, because this product is the metabolite of common vitamins, it does not have the same side effect profiles that other drug type products for these indications do. Therefore, besides the fact of just being sensitive, there are generally no side effects.

 

CEOCFO: Do people find your products on their own or are doctors recommending them?

Mr. Robinson: Our products are prescription and we promote these products to legalized prescribers for their prescriptive use.

 

CEOCFO: Is the medical community receptive to your products?

Mr. Robinson: Yes, always. If there is a safer more natural way to address mental issues everyone is interested in hearing about this and giving it a try.

 

CEOCFO: It is safe and effective, so why would someone choose not to use your EnLyte product?

Mr. Robinson: Normally after we introduce and discuss EnLyte with prescribers, most of them actually say this. The main concern is always cost.  But EnLyte is covered by 77% of all insurances across the US with an average copay of $44 per month.  We also provide a $40 off copay coupon and the worst case scenario is $55 through our cash pay mail order house.

 

CEOCFO: What is the competitive landscape?

Mr. Robinson: There are one or two other products out there that are also prescription folates, but they are considered medical foods, so they have a different distinction with regards to insurance and payment, as compared to our product. They also don’t contain all of the ingredients that EnLyte does. Therefore, the landscape is really narrow with regard to these products for different reasons.

 

CEOCFO: Would you tell us about your other product?

Mr. Robinson: Yes, we actually have two products. We have EnLyte and we also have a product called EnBrace HR, with the HR standing for “Homocysteine Reduction” or “High Risk”. Our EnBrace HR product it is being promoted in the pregnancy community, or OBGYN community for high risk Neural Tube Defects and for the folate deficient patient with peri or postpartum depression. There has always been a need in the Rx prenatal market for a product with 4 times more folate than your average prenatal to meet the recommendations for the “High Risk” pregnant patient.

 

CEOCFO: Would you tell us about the potential link to autism and how your EnLyte product applies to that indication?

Mr. Robinson: Autistic children and autistic adults are at risk for not methylating properly generally because they have a high incidence of MTHFR Polymorphism and GI absorptive issues. This can create lack of neurotransmitter and glutathione production. Extreme oxidative stress and improper brain circuiting can occur. Also with ineffective methylation the associated build up of homocysteine can effect excitability. EnLyte contains all of the pre-metabolized folates, coenzymes, and cofactors that are needed to normalize methylation. Addressing this issue in autism can help with comorbidities that affect these folks and deal directly biochemically with the root cause of some of their symptoms. In addition, large clinical studies show that increased folates, like with EnBrace HR, can help prevent autism in offsprings.  Folates may be a part of answer to the puzzle that is Autism Spectrum Disorder.

 

CEOCFO: What were the challenges in developing your products?

Mr. Robinson: Pinpointing and developing the exact refined ingredients that directly address positive methylation. It was a great effort. But the work is done and all of these targeted ingredients are in a once a day small Gelcap.

 

CEOCFO: What is ahead and how will you continue introducing people to your products?

Mr. Robinson: We are just scratching the surface of promotion and education with this product nationally. We have just put together our EnBrace HR product and we are now promoting that in the OBGYN community. In addition, we have another product on the horizon that combines our product with another standard pharmaceutical product for depression. What we are trying to do is to educate the physician community on the value of folate products in their patients for effectiveness, safety and general use. Much of this has to do with genetic issues, and now that the genome has been mapped and these genetic defects that effect folate metabolism have been demonstrated and can be tested for, a targeted product like EnLyte can address this. Therefore, the education on what is now available in the science of personalizing medicine with regard to folate deficiency and all of the disease processes that it effects is monumental, so that is our primary focus at this point.

 

CEOCFO: Will you be seeking funding or partnerships as you try to get the word out?

Mr. Robinson: We are in discussions with other companies that do genetic testing and identify exact needs for our products, in order to collaborate with them to get this message to those physicians that actually need the product. However, we are mainly pushing this message and our products forward ourselves. For that reason, it is slow. We are a small company, but this is the direction that we have chosen.

 

CEOCFO: How do you personally deal with the frustration of knowing that you have something that can help so many people, yet it is so hard to reach them?

Mr. Robinson: The way we do that is to steadily promote heavily on a daily basis and try to get our message across to one prescriber at a time. Success for our company because we are a small company is not as large as it would have to be for a much larger company. Therefore, we are patient with what we are doing. It is frustrating considering the opportunity, but fortunately the actual difficulties with this product provide a certain amount of intellectual protection and our period is longer concerning having to be a huge success.

 

CEOCFO: Why pay attention to JayMac Pharmaceuticals, EnLyte and EnBrace HR?

Mr. Robinson: People should pay attention to JayMac Pharmaceuticals primarily because our products have caught up to the science of the need for personalizing medication. EnLyte and EnBrace HR provide targeted folate needs for specific patient types, and if you can treat those patients’ folate deficiencies safely and effectively then you are way ahead of the game. Getting to the root cause of disease issues, particularly mental health is very exciting.



 

"People should pay attention to JayMac Pharmaceuticals primarily because our products have caught up to the science of the need for personalizing medication. EnLyte and EnBrace HR provide targeted folate needs for specific patient types, and if you can treat those patients’ folate deficiencies safely and effectively then you are way ahead of the game. Getting to the root cause of disease issues, particularly mental health, is very exciting."
- Towny Robinson



 

JayMac Pharmaceuticals, LLC

 

www.EnLyteRX.com

 

Contact:

Towny Robinson, CEO

JayMac Pharmaceuticals

337-351-6721

harold.robinson@lwdrx.com



JayMac Pharmaceuticals, LLC
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