Nutra Pharma Announces Orphan Drug Applications for RPI-78M
May 26, 2015
Nutra Pharma has announced that they have engaged Medical Strategy Consultants, LLC to aid in the creation and filing of Orphan Drug applications with the US Food and Drug Administration.
May 26, 2015 -- Coral Springs, Florida -- Nutra Pharma Corporation (OTC: NPHC), a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that they have engaged Medical Strategy Consultants, LLC to aid the company in the filing of Orphan Drug applications with the U.S. Food and Drug Administration ("FDA"). The first application under development is for the treatment of Pediatric Multiple Sclerosis with the Company's lead drug candidate, RPI-78M.
“RPI-78M has been studied extensively for autoimmune and neurologic disorders," stated Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. "Our goal now is to get the drug into trials as soon as possible. We believe that taking RPI-78M to an Orphan indication will be the most expedient and cost-effective way to get this therapy into the hands of those who need it most,” he continued. "We're confident that we can help patients who suffer from Pediatric Multiple Sclerosis and we are dedicated to moving this process forward immediately. Should Orphan Drug Designation be granted, regulatory approval of RPI-78M could be significantly expedited; and, upon marketing approval, receiving market exclusivity for RPI-78M would be extraordinarily beneficial to Nutra Pharma,” he concluded.
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. 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 decision to proceed with an Orphan Drug Designation submission is part of Nutra Pharma’s plan to move forward with the preparation of an Investigative New Drug Application.
Nutra Pharma has engaged Medical Strategy Consultants, LLC to assist the Company in the filing of multiple Orphan Drug Designation applications with the FDA. The first application under development is for the treatment of pediatric multiple sclerosis with the Company's lead drug candidate, RPI-78M. In order to create the application, RPI-78M needed to meet several key criteria. This included preclinical data in support of the drug that provided a reasonable rationale for the treatment of the disease based on its potential ability to treat the symptoms of multiple sclerosis.
Multiple Sclerosis (MS) is the most common autoimmune disorder affecting the central nervous system. The National Multiple Sclerosis Society estimates that MS affects approximately 400,000 people in the U.S. and 2.5 million worldwide. MS symptoms can start anywhere between 10 and 80 years of age, but onset is usually between 20 and 40 years, with a mean of 32 years and is twice as common in women as in men. In 2013, 20,000 people died from MS, up from 12,000 in 1990. 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 U.S. 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.
Venoms have proven to be a potent source of molecular tools which have greatly enhanced our understanding of cell function. The approval of several neurotoxins as human therapeutics has unveiled new opportunities for the treatment of disease. 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.
For additional information about Nutra Pharma, visit: http://www.NutraPharma.com or http://www.nyloxin.com http://www.petpainaway.com
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 engagement of the Medical Strategy Consultants 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.