December 09, 2015
December 9, 2015 -- Coral Springs, Florida -- Nutra Pharma Corporation (OTCQB: NPHC), a biotechnology company marketing Nyloxin® and Pet Pain-Away in the over-the-counter (OTC) pain management market, and which is also developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that they have applied for an Orphan Drug designation from the US-FDA for the Company's RPI-78M drug candidate for the treatment of Myasthenia Gravis (MG). On September 8, 2015, the Company announced that they had been granted an Orphan Designation for the treatment of Pediatric Multiple Sclerosis. The designation is designed to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.
“We have been clear over the last year that we would be moving our drug platforms forward," stated Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. "This includes our work in Pediatric Multiple Sclerosis as well as additional potential Orphan Designations for our therapeutic pipeline,” he continued. “We expect to receive the orphan designation for MG. In the meantime, we will continue to work with our FDA consultants to prepare for an Investigative New Drug Application as we develop the clinical trial protocols for Pediatric MS," he concluded.
Myasthenia gravis is a chronic autoimmune neuromuscular disease characterized by varying degrees of weakness of the skeletal (voluntary) muscles of the body. The name myasthenia gravis, which is Latin and Greek in origin, literally means "grave muscle weakness." The hallmark of myasthenia gravis is muscle weakness that increases during periods of activity and improves after periods of rest. Certain muscles such as those that control eye and eyelid movement, facial expression, chewing, talking, and swallowing are often, but not always, involved in the disorder. The muscles that control breathing and neck and limb movements may also be affected. RPI-78M is believed to be effective in the treatment of MG through the modulation of the immune system, preventing autoimmune effects.
The designation of RPI-78M as an Orphan Drug would provide Nutra Pharma with a 7-year period of market exclusivity in the U.S. upon approval of the drug, as well as tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, 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 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. The Orphan Drug Act of 1983 is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as those affecting fewer than 200,000 Americans at any given time.
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 with a very large therapeutic window. 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 diseases.
About Nutra Pharma Corp.
Nutra Pharma Corporation operates as a biotechnology company specializing in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases, including Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain. Additionally, the Company markets drug products for sale for the treatment of pain under the brand Nyloxin® and Pet Pain-Away.
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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 Orphan Drug application for RPI-78M 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.