BioStem Technologies 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 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. 

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.