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Bionutrics to test equivalency of generic drug candidate SNG1001a
By Angela McDaniels
Seattle, Jan. 18 - Bionutrics Inc. said it will conduct studies to demonstrate the bioequivalency of its generic drug candidate SNG1001a in order confirm the formulation and biostudies previously undertaken in India.
SNG1001a is a controlled-release generic formulation of a branded drug in a treatment category with annual U.S. sales in excess of $1.4 billion, the company said.
Bionutrics expects to submit an Abbreviated New Drug Application to the Food and Drug Administration - the company's first - after the completion of these studies.
"We expect this development effort, if successful, to result in a filing with the FDA within the next 12 months," chairman and chief executive officer Ronald H. Lane said in a company news release.
"SNG1001a has the opportunity to be a 'first to file' ANDA, which could be awarded periods of marketing exclusivity," Lane added.
The company plans to use Kirk Pharmaceuticals LLC of Ft Lauderdale, Fla., as its designated manufacturer. Bionutrics cited this as an underlying reason for the previously announced, intended acquisition of Kirk Pharmaceuticals, according to the release.
"U.S. development initiation of SNG1001a is the first step by Bionutrics in commercializing a product employing the company's proprietary oral controlled-released drug delivery technology," Nirmal Mulye, Bionutrics chief scientific officer, said in the release. "This is the first product in our extensive drug pipeline to reach this stage."
Bionutrics is a specialty pharmaceutical company based in Phoenix that develops, manufactures and commercializes oral, controlled-release generic drugs and improved formulations of previously approved drugs.
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