On February 19, 2020 Humanetics Corporation (Humanetics) reported that it has entered into a definitive agreement with DSM Nutritional Products Ltd of Kaiseraugst Switzerland to acquire all of DSM’s assets related to the manufacture of the active pharmaceutical ingredient (API) in BIO 300, a clinical stage drug being developed by Humanetics for oncology and biodefense applications (Press release, Humanetics, FEB 19, 2020, View Source [SID1234554521]). DSM developed and patented a method to produce a highly pure form of the API.
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Included in the acquisition are patents, trademarks, trade secret manufacturing processes, analytical methods, regulatory filings, and a large number of nonclinical and clinical safety studies. Humanetics plans to transfer the manufacturing process to a site in the United States.
BIO 300 is a clinical stage drug under development to protect normal tissues from the harm caused by radiation. The drug’s radioprotective effects were originally discovered by researchers within the Department of Defense at the Armed Forces Radiobiology Research Institute. Humanetics has received significant federal funding to continue advancement of BIO 300 toward FDA approval. Humanetics has also initiated clinical studies for the use of BIO 300 to reduce the toxicity of radiation used in cancer treatment.
"We have had a long and successful collaboration with DSM, and we are excited to add these important assets to our BIO 300 program," said John Dykstra, Chief Operating Officer at Humanetics. "The assets we are acquiring from DSM will allow us to control and protect our entire manufacturing process from start to finish."