PHOENIX, Dec. 13 /PRNewswire-FirstCall/ -- Bionutrics, Inc., (OTC: BNRX - News) announces planned clinical trials for the first in a series of new proprietary dietary supplement candidates.
Bionutrics announced that it has completed formulation of the first in a series of proprietary products developed to address lipid metabolism and assist in the maintenance of normal cholesterol. The Company expects to begin a human, double-blind, placebo controlled, clinical trial in January to confirm the effectiveness of its first new product.
Ronald Howard Lane, Ph.D., Bionutrics' Chairman and Chief Executive Officer stated, "We are very hopeful of the outcome of the clinical trials for this series of new proprietary products that we are developing. Success of these trials will give Bionutrics an opportunity to generate revenue while pursuing its longer term 505(b)(2) drug development program with Nostrum Pharmaceuticals."
Bionutrics and Nostrum Pharmaceuticals, Inc. announced a product and technology license agreement on September 8, 2004, wherein Nostrum contracted to supply Bionutrics with certain drug technology in connection with 505(b)(2) drug candidates. Drug applications referred to as 505(b)(2) candidates commonly include potential drug products that are potentially "brandable," may have higher margins than generics, but lower development cost that new chemical entities. Nostrum, is a New Jersey based pharmaceutical company specializing in formulation and delivery drug technology, which has focused on alternative, 505(b)(2) delivery of existing chemical formulations. In exchange for the technology and product rights extended to Bionutrics, Nostrum received shares of Bionutrics' common stock, making Nostrum the largest shareholder of the Company. Bionutrics has certain obligations under the license agreement, which if not met would give Nostrum a right of rescission (which would trigger the return of its Bionutrics' stock). The date for fulfillment of the obligations has been extended to December 31, 2004. There is no assurance that Bionutrics will meet those requirements of the licensing agreement.
"Safe Harbor" statements under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements including but not limited to, the Company's current expectations, belief, future plans and strategies, anticipated events or trends concerning matters that are not historical facts. Such forward-looking statements include, among others, statements of future plans relating to the Company's product development, financial plans, business strategy and growth strategy. These statements are subject to risks and uncertainties including capital needs, new product development, future research, clinical trials and their outcomes, product demand and market acceptance, reliance on key strategic alliances, availability of raw materials, regulatory environment and government approval processes, requirements still to be met in the Bionutrics/Nostrum licensing agreement, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission.