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VistaGen Therapeutics, Inc. (VSTA) Drug Rescue Programs Seen as Viable Solution to Derailed Drug Candidate Development
VistaGen Therapeutics is a stem cell company which centers its attention on drug rescue and regenerative medicine – a type of tissue engineering and molecular biology that deals with the process of replacing, engineering or regenerating human cells, to restore or establish normal function. Believing better cells lead to better medicine, the company feels a vital aspect to making these cells is controlling the differentiation of human pluripotent stem cells commonly referred to as, ‘the building blocks’ of all cells within the human body. VSTA’s stem cell R&D teams have focused on controlling the differentiation of pluripotent stem cells for over 15 years to produce multiple types of mature, functional, adult human cells, with emphasis on human heart and liver cells for drug rescue applications.
The company believes a notable number of pharmaceutical companies are experiencing critical R&D productivity issues as evidenced be their low number of FDA-approved products each year. As an example, the U.S. pharmaceutical industry invested over $51 billion in R&D and the Center for Drug Evaluation and Research (CDER) of the FDA approved a total of only thirty-nine (39) novel drugs, known as New Molecular Entities (NMEs). In 2013, CDER approved only twenty-seven (27) NMEs, thirteen (13) of which NME approvals (48%) were received by only five (5) pharmaceutical companies, including Bayer (2), GlaxoSmithKline (4), Johnson & Johnson (3), Roche (2) and Takeda (2).
Despite significant R&D investment levels by the global pharmaceutical industry since 2003, the FDA has only approved an average of twenty-six (26) NME’s annually. The company’s position is that many pharmaceutical companies with established products that are no longer patent protected are also experiencing substantial market pressure from generic competition. As a result of weak R&D productivity, shrinking product pipelines and generic competition, VSTA believes there will continue to be a critical need among pharmaceutical companies to license the new, safer Drug Rescue Variants they are focused on developing.
Pointing to estimates that show about one-third of all potential new drugs candidates fail in their development stages due to unexpected safety concerns, VSTA presents its drug rescue programs as a viable solution which can recapture substantial value from the prior investment by pharmaceutical companies whose research has been paused on the once promising drug candidate due to heart or liver safety concerns.
For more information on the company, visit www.vistagen.com
