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(2) Accelerated FDA Approval Process - EconoTimes)
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Pompano Beach, FL, March 26, 2018 -- BioStem Technologies, Inc. (OTC: BSEM) (“BioStem” or the “Company”), a global life sciences corporation providing innovative technologies with a focus in Pharmaceuticals and Regenerative Medicine, today announced that it has signed a Letter of Intent (“LOI”) with CCM Pharma Solutions ("CCM"). CCM has identified several drugs in the cardiovascular, metabolic disease and CNS disease space, some of which represent over a billion dollars in annual sales. BSEM and CCM will co-develop NDA and ANDA drugs through the 505(b)(2) accelerated FDA approval process.
BioStem’s Pharmaceutical division is excited to add these products into its pipeline. Our current development effort is increasingly directed towards improved solid-to-liquid drugs which follow an NDA 505(b)(2) regulatory pathway. Four initial products have been identified for co-development with CCM with a currently expected market revenue potential up to $30-35MM each in gross annual revenue sales per product over the term of exclusivity in the market totaling $120MM to $140MM in revenue potential. With additional funding, the Company expects to increase its research and development emphasis on new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program and identifying additional products for reformulation.
The 505(b)(2) pathway both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. One benefit of leveraging the development of NDA 505(b)(2) drugs is that these products can potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route, upon approval of the FDA.
"Our collaborative goal with CCM Pharma Solutions is to develop products that will be of great benefit to patients requiring liquid dosage forms of current branded drug products, putting the patient and their Quality of Life first," said Larry Jones, Chief Revenue Officer of BioStem Technologies.
About CCM Pharma Solutions
CCM Pharma Solutions focuses on prescription drugs in large and growing markets, including obesity and lifestyle-induced diseases. A primary driver of the CCM Pharma Solutions value proposition is in the field of reformulation of popular drugs 505(b)(2), and the development of new chemical entities. This results in the leveraging of their known safety and efficacy, thereby minimizing the risk of failure.
About BioStem Technologies, Inc. (OTC PINK: BSEM): BioStem Technologies, Inc. is a global life sciences corporation, providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine. The Company’s mission is to discover, develop and produce the most effective Pharmaceutical and Regenerative Medicine products in the world. The Company is comprised of a diverse group of scientists, physicians, and entrepreneurs who collaborate to create innovative products. These technologies improve the Quality of Life for our patients and, as a result, drive shareholder value.
Forward-Looking Statements: Except for statements of historical fact, the matters discussed in this press release are forward-looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "future," "plan" or "planned," "expects," believe" or "projected." These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition, and additional risk factors, as discussed in reports filed by the Company with OTC Markets.
BioStem Technologies, Inc. Phone: 954-380-8342 Website: http://www.biostemtech.com Email: [email protected] Twitter: @Biostemtech Facebook: BioStem Technologies Investor Relations: Andrew Van Vurst [email protected] (954) 380-8342
