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
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