Nutra Pharma Corp (NPHC)

[maverick81]

NPHC - ORPHAN DRUG STATUS DESIGNATION


In September of 2015 NPHC was granted Orphan Designation by the US-FDA for the treatment of Pediatric Multiple Sclerosis. We are currently working with potential sites of care to conduct a Phase I/II in Pediatric MS. The designation of RPI-78M as an Orphan Drug provides Nutra Pharma with a 7-year period of market exclusivity in the U.S. once the drug is approved. Additional benefits over conventional drug applications include: tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, plus assistance from the FDA in the drug development process and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees which could be in excess of $2.5 million. The granting of Orphan Drug Designation allows the Company to move forward with their preparation of an Investigative New Drug Application and proposal of clinical trials. The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. According to the FDA, the Orphan Drug program has successfully enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. Evaluate Ltd., in its 2014 EvaluatePharma Orphan Drug Report, estimated that orphan drug sales will constitute 19% of the total share of prescription drug sales by 2020, totaling $176 BILLION.


Profitability and Market Value of Orphan Drug Companies: A Retrospective, Propensity-Matched Case-Control Study

Link to the article:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0164681

"We conducted a retrospective, propensity score matched study of publicly-listed orphan companies. Cases were defined as holders of orphan drug market authorisation in Europe or the USA between 2000–12. Control companies were selected based on their propensity for being orphan drug market authorisation holders. We applied system General Method of Moments to test whether companies with orphan drug market authorization are valued higher, as measured by the Tobin’s Q and market to book value ratios, and are more profitable based on return on assets, than non-orphan drug companies."

Publicly listed pharmaceutical companies that are orphan drug market authorization holders are associated with higher market value and greater profits than companies not producing treatments for rare diseases.

SUMMARY: HAVING ORPHAN DRUG STATUS IS A BIG DEAL!!



Multiple Sclerosis (MS)

Multiple Sclerosis (MS) is thought to be an autoimmune disease that primarily causes central nervous system problems. In MS, the insulating fatty material surrounding the nerve fibers, also known as myelin, which functions to speed signaling from one end of the nerve cell to the other, is attacked by cells of the immune system causing problems in signal transduction. MS is the most common of demyelinating disorders, having a prevalence of approximately 1 per 1,000 persons in most of the United States and Europe. According to the Accelerated Cure Project for Multiple Sclerosis, a national nonprofit organization, 400,000 people in the US are affected by MS and another 2.1 million globally, with 10,000 new cases diagnosed in the US every year. According to the National Multiple Sclerosis Society, although MS occurs most commonly in adults, it is also diagnosed in children and adolescents. Estimates suggest that 8,000-10,000 children (up to 18 years old) in the United States have MS, and another 10,000-15,000 have experienced at least one symptom suggestive of MS. Studies suggest that two to five percent of all people with MS have a history of symptom onset before age 18.


RPI-78M has been utilized in two clinical studies, which were completed at the Charles Dent Metabolic Unit located in London, England. The last trial was classified as a Phase IIb/IIIa study. These studies provided important safety data, showing RPI-78M to be well tolerated by the patients. Further study is warranted to provide data on the potential efficacy of RPI-78M to treat the symptoms of AMN.

RPI-78M has shown efficacy in animal models (EAE) for MS and ReceptoPharm is planning new animal studies to gain more insight into the levels of protection that the drugs afford. In one study conducted in August 2007, all members of an untreated animal control group developed signs of disease with different levels of paralysis/muscle weakness. A similar group in the August 2007 study treated with RPI-78M showed no disease in 90% of the animals in both acute and chronic applications of the test. Moreover, there were no toxicities reported though the animals which received doses the equivalent of 280 times a human dose.

* MS 15-18 billion dollar per year market

* No descent drugs for treatment of MS. They Shut off immune system

* Modulates the immune system.

* 300 patients trialed - disease progression stops and symptoms improve. AMAZING

* FDA Trials Phase II coming

* Addresses multiple health conditions
http://www.receptopharm.com/drug_development/

* RPI-78M is being developed for the treatment of Multiple Sclerosis (MS) and Adrenomyeloneuropathy AMN).Other neurological disorders that may be served by RPI-78M include Myasthenia Gravis (MG) and Amyotrophic Lateral Sclerosis (ALS)

* Collaboration: University of Maryland,production of RPI-78M for the planned upcoming clinical trials in Pediatric Multiple Sclerosis
https://finance.yahoo.com/news/nutra-pharma-announces-collaboration-university-123000318.html

It feels good Knowing that I am invested into a company that is actively seeking to create a revolutionary new drug that could help thousands of children with MS... Yet another reason I am invested in NPHC.


MARKET VALUES OF MS

MS affects an estimated 2.5 million people globally with approximately 400,000 sufferers in the United States. There are 12 approved drugs for the treatment of this disease. According to an April 2015 article published in the journal Neurology , the average annual cost of these drugs has increased to over $60,000 per person. In 2013, sales by one manufacturer, Teva, were reported to be $4.328 billion for its drug, Copaxone. Biogen has the largest market share in the MS drug category; bringing in $8 billion from the sales of Avonex, Tysabri and Tecfidera. The global multiple sclerosis therapeutics market is expected to reach USD 24.8 billion by 2024 according to a May, 2016 report by Grand View Research, Inc.

MS MARKE VALUE CURRENTLY 8 BILLION AND EXPECTED TO REACH 24.8 BILLION BY 2024!!!!!


MOST COMPANIES WITH ORPHAN DRUG STATUS HAVE MARKET CAPS IN THE HUNDREDS OF MILLIONS! OWC*P RAN TO 300 MILLION MARKET CAP JUST ON THE RUMOR OF GETTING ORPHAN DRUG STATUS!!

NPHC deserves a market cap FAR HIGHER than what we have today!!



Mav