BioStem Technologies Announces Letter of Intent With CCM Pharma Solutions
BioStem Technologies, Inc. recently announced it has signed a Letter of Intent with CCM Pharma Solutions. 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. Its current development effort is increasingly directed toward 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 MM to 35 MM each in gross annual revenue sales per product over the term of exclusivity in the market totaling $120 MM to $140 MM 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.
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.
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 composed 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.
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