In calendar year 2013, the U.S. FDA’s Center for Drug Evaluation and
Research (CDER) approved 27 novel new medicines (NMEs) approved under New Drug
Applications (NDAs) and Biologics License Applications (BLAs). This comes from
a report from the FDA that also says submissions for novel new medicines in the
last decade have been relatively flat, with the exception of 2012.
While all applications submitted in 2013 were not accepted for filing as
of December 31, 2013, CDER forecasts that about 36 total applications were
submitted for 2013, meaning nine were left on the table for one reason or
another.
This information is of particular value to VistaGen Therapeutics, a
small-cap biotech company focused on reviving once-promising drug candidates
that were shelved due to toxicity issues. The expense of failure is staggering
for the company and investors that have invested considerable time and money in
their drug candidates. This high cost of failure associated with unexpected
heart and liver toxicity and metabolism issues drives the cost to develop drug
candidates higher and results in relatively low annual number of FDA-approved
NMEs.
VistaGen believes that the majority of pricey and unexpected heart and
liver toxicity and metabolism issues stem from limitations of the major
toxicological testing systems currently used in the pharmaceutical industry,
namely animal testing and cellular assays based on transformed cell lines and
human cadaver cells.
The company’s solution is its Human Clinical Trials in a Test Tube™,
which utilizes human pluripotent stem cells (hPSCs), cells that have the
ability to be geared and developed into any other kind of cell in the human
body, and differentiates them into useable human heart cells and human liver
cells. VistaGen’s strategy is to apply this technology combined with medicinal
chemistry to generate new, proprietary drug rescue variants of once-promising
small molecule drug candidates that were discarded for safety concerns.
Using mature human heart cells produced from its stem cell technology,
VistaGen has developed CardioSafe 3D™, a novel, three-dimensional (3D) bioassay
system for predicting the in vivo cardiac effects, both toxic and non-toxic, of
drug rescue variants and other small molecule drug candidates before they are
tested in animals and humans. The company is further expanding its drug rescue
capabilities by developing LiverSafe 3D™, a novel bioassay system using
hPSC-derived human liver cells to assess potential liver toxicity and adverse
drug-drug interactions in drug rescue variants and other new drug candidates
early in development, before animal and human testing. Identifying toxicity
issues early in the development process can save considerable research, money
and other resources.
Of the 27 drugs recently approved by CEDR, at least two pertained to
cardiac disease. VistaGen is well-positioned to take advantage of unmet needs
in this niche market of the healthcare industry.
For more information on VistaGen visit www.vistagen.com
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