Dear Members,
First – Let’s Look at Netherton Syndrome
I am not going to show you pictures of Netherton Syndrome. That’s not because you should not see how horrible this affliction is, but I do not want to violate the privacy of any patient (mostly children) who have this devastating – lifetime – condition. The reason I say it is mostly children that have this, it is because they have it from birth and it is so devastating that the typical patient does not reach his or her twenties. Although some do make into their twenties or thirties, it is a very painful and brave existence.
The reason Netherton Syndrome is important in relation to Skinvisible is that Skinvisible had developed a treatment that utilizes its unique, patented polymer to deliver a formulation of active ingredients that offer the potential for meaningful relieve to sufferers of Netherton Syndrome.
Let me first introduce you to Neterton Syndrome more fully. Here is a description of the condition:
“Netherton Syndrome is a serious skin disorder caused by damage in a gene called SPINK5. This gene controls the formation of a protein called LEKTI, which important for skin barrier function. LEKTI inhibits certain enzymes (serine proteinases) in the outermost layer of the skin (epidermis). The function of the serine proteinases is to break down the intracellular cement that holds together the horny cells in the epidermis, in order for the skin to be able to shed cells (known as cell desquamation). LEKTI deficiency leads to an uninhibited desquamation of horny cells, and as a result the skin becomes red and scaly. The barrier function of the skin is also affected. The permeability of the skin increases, and its capacity to bind water decreases, which causes dryness. The thinness of the barrier also results in over absorption of chemicals, for example topical medical treatments. Historically one in ten infants dies before their first birthday. Currently there are no proven treatments to cure this condition.”
No description can ever fully tell the story of suffering of those afflicted with this devastating disease. Improving the lives of those who suffer from Netherton Syndrome is one of the goals of Skinvisible, and with their polymer delivery system the Company has an opportunity to do just that.
It’s important to not only read about the condition but to see the condition as well. You should view the images at this link that follows. Read the information on that site to get a much fuller overall understanding of this disease. SEE IMAGES HERE
Now – Let’s Look at what “Orphan Drug Designation” Really Means
First it is important to note that Skinvisible does not have this status in either the US or in Europe. More on that below. Getting that status is what makes it far more viable for Skinvisible to create a meaningful product.
The Food & Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) did not create the “orphan drug designation” to benefit “companies.” It was created as a way to make sure that smaller diseases and medical conditions are not ignored by pharmaceutical companies and medical researchers in the quest for profits. What this designation means is that the FDA and the EMA have created meaningful incentives to companies – like Skinvisible – to go forward with research and bring treatments and medicines forward for diseases with very few patients. Netherton Syndrome is devastating to those that have it. There are many numbers out there as to how many patients there truly are, but nobody can put a real number on it. There would likely not be enough patients to make it financially plausible without the potential for “orphan drug status.”
What benefits does a company, like Skinvisible, should they get this status:
This is from the FDA’s web site:
DESIGNATING AN ORPHAN PRODUCT: DRUGS AND BIOLOGICS
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The combination of the product to treat the rare disease or condition must meet certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for the tax credit and marketing incentives of the ODA. A marketing application for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user fee unless the application includes an indication for other than a rare disease or condition. READ IT HERE
These benefits are similar in Europe as well. The bottom line is that these benefits are so significant that companies, like Skinvisible, will truly benefit greatly if they bring the right drug formulation to market.
ONE NOTE: With or without this designation, Skinvisible continues its research into Netherton Syndrome.
There are examples of how such a designation has benefited not only the patients, but the companies that bring the drugs to market after achieving this designation. Ultimately, this is for the benefit of the patient. This makes it a win for the patient and a win for the company that brings the treatment.
LATER TODAY:
Skinvisible is about much more than this one treatment for Netherton Syndrome. They have many products at market. Let’s take a look at some of these next.
Thank you,
John Pentony
Publisher, StockGuru.com
MORE INFORMATION ON SKINVISIBLE:
Skinvisible Pharmaceuticals, Inc. (OTCBB: SKVI)
CORPORATE CONTACT:
Doreen McMorran
Skinvisible Pharmaceuticals, Inc.
Phone: 702-433-7154
Email: [email protected]
ON THE WEB:
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