Compensated Awareness Post View
Disclaimer
VistaGen Therapeutics, Inc. (VSTA) Strategy Offers Foresight in Drug Candidate Approval Process
VistaGen Therapeutics believes the U.S. pharmaceutical industry is facing a drug discovery and development crisis. In 2012, the U.S. pharmaceutical industry invested over $48 billion in research and development. As a result the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) approved a total of 39 novel drugs, known as New Molecular Entities (NMEs). In 2013, the FDA approved 27 NMEs.
Despite the aforementioned monumental investment by the pharmaceutical industry, since 2003, the FDA has approved an average of 26 NMEs per year. VSTA believes the high cost of drug development and relatively low annual total of FDA-approved NMEs are attributable in large part to the cost of failure associated with unexpected heart and liver safety issues. In turn, the company believes unexpected heart and liver safety issues often result from limitations of the major toxicological testing systems used in the pharmaceutical industry, namely animals and cellular assays based on transformed cell and immortalized cell lines and explanted primary cells, including human cadaver cells.
After spending millions of dollars over nearly a decade to discover, optimize, and validate the potential efficacy of a promising new drug candidate and subsequently move it into preclinical development, a biotechnology or pharmaceutical company can see their drug candidate fail to progress due to unexpected heart or liver safety issues. The company then often discontinues the program for their once-promising drug candidate and indefinitely pause developmental progress despite the positive data that shows potential therapeutic and commercial benefits. As a result, the company’s significant prior investment in discovery and development may be lost.
VistaGen is in the business of believing that using human heart and liver cells can make better toxicological testing systems and better drug candidates. The company believes that the human heart and liver cells they make, and the toxicological testing systems in which they use them, can transform drug development in the pharmaceutical industry. It is estimated that about one-third of all potential new drugs candidates fail in preclinical or clinical development due to unexpected safety concerns.
For more information on the company, visit www.vistagen.com
