September 8, 2015 -- Coral Springs, Florida -- Nutra Pharma Corporation (OTC: NPHC), announced today that they have received Orphan Drug designation from the US-FDA for the Company's RPI-78M drug candidate for the treatment of Multiple Sclerosis in children.
“Receiving Orphan Drug Designation by the FDA is a significant milestone for our Company,” stated Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. “Juvenile MS is an important disease area that is currently not being addressed by other drugs on the market and, based on our pre-clinical and open-label studies using RPI-78M, we believe that it has the ability to successfully navigate the approval process,” he continued. “Our next steps are to prepare an Investigative New Drug Application with the FDA and to develop the clinical trial protocols needed for drug approval," he concluded.
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, totalling $176bn.
RPI-78M was originally derived from an extract of cobra venom and is an antagonist of the nicotinic acetylcholine receptor. The drug has a remarkably low toxicity and has a wide range of applications. Scientific publications have demonstrated that native and modified neurotoxins can protect nerve cells from early cell death. Furthermore, it is expected that RPI-78M may be beneficial in neuromuscular disorders where the activity of nicotinic acetylcholine receptor has been compromised. The proprietary technology is covered by patents describing the application and use of RPI-78M in the treatment of autoimmune and viral diseases.
About Nutra Pharma Corp.
Nutra Pharma Corporation operates as a biotechnology company marketing Nyloxin® and Pet Pain-Away in the over-the-counter (OTC) pain management market. It is also developing drugs for the treatment of Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), and Adrenomyeloneuropathy (AMN). The Company has specialized in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases. For additional information about Nutra Pharma, visit:
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The granting of Orphan Drug status for RPI-78M by the FDA should not be construed as an indication in any way whatsoever of the future value of the Company’s common stock or its financial value. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.