Nutra Pharma Corp.’s (NPHC) 7-year Marketing Exclusivity for Pediatric MS RPI-78M is more than just Luck

In September 2015, Nutra Pharma Corporation (OTCQB: NPHC), in what CEO Rik Deitsch has called “the most substantial event in the history of our drug discovery efforts,” was granted Orphan Status for RPI-78M for the treatment of Juvenile or Pediatric Multiple Sclerosis (MS). 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.’

Orphan Drug status also 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. It may, however, accept such applications, and it may accept and approve applications for drugs having the same active moiety, for a different indication. Also, the FDA may accept and approve a subsequent orphan drug application for the ‘same drug’ and the ‘same orphan indication’, if the applicant demonstrates that the product is ‘clinically superior’, safer, more effective or significantly more convenient than the first drug.’

The Orphan Drug Act was passed by Congress in 1983 to encourage research and development of treatments for rare diseases. An orphan drug is a drug intended to treat a condition affecting fewer than 200,000 persons in the United States, or which will not be profitable within 7 years following approval by the FDA. Orphan status and FDA approval are not the same thing. Orphan status does not mean that the FDA has approved the drug.

The right to marketing exclusivity is a valuable one, as Martin Shkreli and Turing Pharmaceuticals have shown. An enlightening article (http://dtn.fm/4bKpR) in Science Translational Medicine tells the amazing saga of Daraprim, or pyrimethamine. The drug was approved by the FDA back in 1953 and manufactured by GlaxoSmithKline (NYSE: GSK), which disposed of its U.S. marketing rights to CorePharma in 2010. CorePharma was later acquired by Impax, which sold Daraprim to Turing for $55 million. In the GlaxoSmithKline days, Daraprim went for about $1 per tablet. After its acquisition by CorePharma, it was selling for around $10 per tablet. Now, Shkreli has appeared before Congress to explain Turing’s decision to raise the price from $13 to $750.

Nutra Pharm has also applied (in December 2015) for Orphan Status for its RPI-78M treatment of myasthenia gravis (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

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