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
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