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
About QualityStocks
QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. We offer several ways for investors to find, evaluate, and learn more about investing in these companies.
QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. We offer several ways for investors to find, evaluate, and learn more about investing in these companies.
Sign up for “The QualityStocks Daily Newsletter” at www.QualityStocks.net
The Quality Stocks Daily Blog http://blog.qualitystocks.net
The Quality Stocks Daily Videos http://videocharts.qualitystocks.net
The Quality Stocks “Ones to Watch” http://gotstocks.qualitystocks.net
Please see disclaimer on the QualityStocks website: http://disclaimer.qualitystocks.net
No comments:
Post a Comment