Orphan Drug Status for RPI-78M Boosts Nutra Pharma
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Posted On: 03/15/2016 5:03:07 PM
Orphan Drug Status for RPI-78M Boosts Nutra Pharma Corp.’s (NPHC) IP Portfolio
Last September’s award of orphan drug status to Nutra Pharma Corporation (OTCQB: NPHC) for RPI-78M for the treatment of Juvenile or Pediatric Multiple Sclerosis was a significant milestone on the company’s road to success as a speculative bio-pharmaceutical company. In an interview (http://dtn.fm/7jXjw) with Stock News Now, CEO Rik Deitsch called the award “the most substantial event in the history of our drug discovery efforts,” but went on to lament that, ironically, the company had been hobbled by its own success.
Although essentially focused on drug discovery, Nutra Pharma markets an over-the-counter (OTC) line of homeopathic remedies. This includes Cobroxin, the first over-the-counter (OTC) pain reliever clinically proven to treat moderate to severe (Stage 2) chronic pain; Nyloxin and Nyloxin Extra Strength. The latter two are the only non-narcotic and non-addictive treatments for severe (Stage 3) pain. Both Cobroxin and Nyloxin were developed by Nutra Pharma’s wholly-owned drug discovery subsidiary, ReceptoPharm, but these OTC remedies put out by Nutra Pharma have attained more marketing visibility and overshadowed its intellectual property (IP) pipeline. Nevertheless, Cobroxin and Nyloxin are just the tip of the Nutra Pharma iceberg. The company holds 21 patents on treatments for myasthenia gravis (MG), juvenile multiple sclerosis (MS), adrenomyeloneuropathy (AMN), human immunodeficiency virus (HIV) and pain. These, Deitsch explains, are the “blood… the genetics of the company.”
Nutra Pharma’s approach to the treatment of Pediatric Multiple Sclerosis (PMS), so called because it refers to sufferers under the age of 16, is a novel one. At present, PMS is treated with immunosuppressive drugs that can only slow the progression of the disease. Based on clinical studies of RPI-78M, Nutra Pharma expects RPI-78M may have the potential to not only stop further development of the disease but reverse its symptoms. Deitsch has speculated, “If we can get the drug through Phase I and Phase II trials, we plan to license it to a large pharma partner. We expect it to change the way we treat autoimmune diseases.”
Orphan Status for a drug brings many advantages. It gives the sponsoring company tax credits that may amount to as much as 50% of the development costs attributable to qualified clinical testing. This could include remuneration to employees to supervise, carry out and support qualified clinical testing activities. Orphan Status can also mean a reduction or exemption from FDA fees. Under various statutes, beginning with the Prescription Drug User Fee Act of 1992 (PDUFA I), the FDA is authorized to assess user and application fees, but it can grant a waiver or deduction of these fees if ‘A waiver or reduction is necessary to protect the public health OR the assessment of the fee would present a significant barrier to innovation because of limited resources available to the person or other circumstances OR the applicant is a small business submitting its first human drug application… for review.’
That’s not all; Orphan Drug status allows a sponsor exclusive marketing rights for a limited period. Orphan Drug Exclusivity (ODE) is typically for a period of 7 years. After it’s granted, the FDA may not approve applications for generic or second innovator products that contain the same active ingredient and are labeled for the same orphan indication.
Nutra Pharma may be helping sufferers of chronic pain mitigate their discomfort, but it’s a company that aims to do a lot more than that. Earlier this year, it announced it had also applied for Orphan Status for its RPI-78M treatment for MG.
In a recent letter to shareholders, Deitsch said, “It is our goal to complete the Phase I/II trials in pediatric MS over the next 18 months and then either move into Phase III trials or seek a licensing partner. As we have always stated, it is our eventual goal over the next several years to market or license our drugs for the treatment of Multiple Sclerosis and HIV/AIDS. This represents the true potential of Nutra Pharma as a Bio-Pharmaceutical company.”
For more information on the company, visit www.NutraPharma.com
Please see disclaimer on the QualityStocks website: http://Disclaimer.QualityStocks.com
Last September’s award of orphan drug status to Nutra Pharma Corporation (OTCQB: NPHC) for RPI-78M for the treatment of Juvenile or Pediatric Multiple Sclerosis was a significant milestone on the company’s road to success as a speculative bio-pharmaceutical company. In an interview (http://dtn.fm/7jXjw) with Stock News Now, CEO Rik Deitsch called the award “the most substantial event in the history of our drug discovery efforts,” but went on to lament that, ironically, the company had been hobbled by its own success.
Although essentially focused on drug discovery, Nutra Pharma markets an over-the-counter (OTC) line of homeopathic remedies. This includes Cobroxin, the first over-the-counter (OTC) pain reliever clinically proven to treat moderate to severe (Stage 2) chronic pain; Nyloxin and Nyloxin Extra Strength. The latter two are the only non-narcotic and non-addictive treatments for severe (Stage 3) pain. Both Cobroxin and Nyloxin were developed by Nutra Pharma’s wholly-owned drug discovery subsidiary, ReceptoPharm, but these OTC remedies put out by Nutra Pharma have attained more marketing visibility and overshadowed its intellectual property (IP) pipeline. Nevertheless, Cobroxin and Nyloxin are just the tip of the Nutra Pharma iceberg. The company holds 21 patents on treatments for myasthenia gravis (MG), juvenile multiple sclerosis (MS), adrenomyeloneuropathy (AMN), human immunodeficiency virus (HIV) and pain. These, Deitsch explains, are the “blood… the genetics of the company.”
Nutra Pharma’s approach to the treatment of Pediatric Multiple Sclerosis (PMS), so called because it refers to sufferers under the age of 16, is a novel one. At present, PMS is treated with immunosuppressive drugs that can only slow the progression of the disease. Based on clinical studies of RPI-78M, Nutra Pharma expects RPI-78M may have the potential to not only stop further development of the disease but reverse its symptoms. Deitsch has speculated, “If we can get the drug through Phase I and Phase II trials, we plan to license it to a large pharma partner. We expect it to change the way we treat autoimmune diseases.”
Orphan Status for a drug brings many advantages. It gives the sponsoring company tax credits that may amount to as much as 50% of the development costs attributable to qualified clinical testing. This could include remuneration to employees to supervise, carry out and support qualified clinical testing activities. Orphan Status can also mean a reduction or exemption from FDA fees. Under various statutes, beginning with the Prescription Drug User Fee Act of 1992 (PDUFA I), the FDA is authorized to assess user and application fees, but it can grant a waiver or deduction of these fees if ‘A waiver or reduction is necessary to protect the public health OR the assessment of the fee would present a significant barrier to innovation because of limited resources available to the person or other circumstances OR the applicant is a small business submitting its first human drug application… for review.’
That’s not all; Orphan Drug status allows a sponsor exclusive marketing rights for a limited period. Orphan Drug Exclusivity (ODE) is typically for a period of 7 years. After it’s granted, the FDA may not approve applications for generic or second innovator products that contain the same active ingredient and are labeled for the same orphan indication.
Nutra Pharma may be helping sufferers of chronic pain mitigate their discomfort, but it’s a company that aims to do a lot more than that. Earlier this year, it announced it had also applied for Orphan Status for its RPI-78M treatment for MG.
In a recent letter to shareholders, Deitsch said, “It is our goal to complete the Phase I/II trials in pediatric MS over the next 18 months and then either move into Phase III trials or seek a licensing partner. As we have always stated, it is our eventual goal over the next several years to market or license our drugs for the treatment of Multiple Sclerosis and HIV/AIDS. This represents the true potential of Nutra Pharma as a Bio-Pharmaceutical company.”
For more information on the company, visit www.NutraPharma.com
Please see disclaimer on the QualityStocks website: http://Disclaimer.QualityStocks.com
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