NBI Pharmaceuticals

After years of researching ways to help people use nutrients to promote their health, in 2010 Drs. Neustadt and Pieczenik began working with the FDA to create natural, safe and effective products to treat rare diseases. They thus created the company, NBI Pharmaceuticals.

The FDA calls rare diseases, "orphan diseases", and in its first year, NBI Pharmaceuticals received 15 deisgnations for orphan disease products. Their research targeted various cancers, neurological and mitochondrial diseases. These designations included four for MK4™ for the possible treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), hepatocellular carcinoma (HCC) and promyelocytic leukemia. The research presented by NBI Pharmaceuticals to the FDA was based on published human clinical trials, case reports and basic research showing MK4's mechanisms of action against cancer cells.

Timothy Cote, MD, who was director at the time of the FDA's Office of Orphan Products Development (OOPD), called the doctors find out who they were. No other company in the history of the orphan drug program has ever received so many designations, let alone so quickly. Dr. Cote asked how NBI Pharmaceuticals, without any employees or backing of large pharmaceutical companies, could have done what no other pharmaceutical company had ever done before.

They are bringing to the pharmaceutical world the same focus, rigourousness of research and unique paradigm that they brough to the dietary supplement world. They are now in discussions to begin clinical trials for their first product to treat two rare cancers.