Monday, December 7, 2015

Nutra Pharma Corp. (NPHC) is “One to Watch”

Nutra Pharma Corp. is a biotech company working in collaboration with its subsidiaries to develop an innovative pipeline of biopharmaceutical products for the management of neurological disorders, cancer, autoimmune, and infectious diseases. At the core of Nutra Pharma’s intellectual property is a unique platform for extracting neurotoxins from Asian cobra venom and transforming them into non-toxic therapeutics.

The ReceptoPharm subsidiary, Nutra Pharm’s drug discovery arm, is focused on the development of new therapeutic agents based upon specialized receptor-binding proteins found in nature, especially those found in snake venom from the cobra. ReceptoPharm’s R&D pipeline consists of several novel therapies in various stages of development to prevent and/or treat multiple sclerosis (MS), human immunodeficiency virus (HIV), adrenomyeloneuropathy (AMN), herpes, rheumatoid arthritis (RA) and pain. The subsidiary also provides small and start-up biotech companies a full range of contract research services through its ISO class 5 and GMP certified facilities in Plantation, Florida.

Nutra Pharma recently received Orphan Drug Status from the FDA for the treatment of pediatric MS for its drug, RPI-78M. The designation of RPI-78M as an Orphan Drug provides Nutra Pharma with a seven-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 Nutra Pharma to move forward with its 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.

ReceptoPharm holds all of the intellectual property for Nutra Pharma’s drug pipeline, while Nutra Pharma directly holds all of the property dealing with their over-the-counter drugs. This includes Nyloxin, an OTC pain reliever for humans, and Pet Pain-Away, a pain reliever for dogs and cats. The company’s Nyloxin product is the first OTC pain reliever clinically proven to treat moderate to severe chronic pain. The drug is available as an oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia and as a topical gel for treating joint pain and pain associated with repetitive stress and arthritis.

Nutra Pharma is a revenue-generating company with 12 patents and patents pending, three completed phase 1/phase 2 clinical trials, and 12 FDA-registered OTC products in the United States. The company also has regulatory clearance for Nyloxin in India, where management believes its initial distribution streams could become the company’s biggest market. Management is also defining its plan to expand into China and Canada while strengthening its position the United States.

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