Friday, March 9, 2012

VistaGen Therapeutics (VSTA) Addresses the Cost of New Drug Development

One of the clear contributors to the exploding price of healthcare is the cost of researching a new drug and bringing it successfully to market. The cost of drug development has grown enormously over the years, and yet there is no formally agreed upon way to calculate the total cost of a new drug. But everyone agrees that the numbers are huge, and it’s this very scale of investment that causes the problem. The cost of sophisticated facilities, equipment, researchers, manufacturing, preclinical and clinical trials, and other elements, many of which may be shared between numerous projects, covering multiple years of development, can make it almost impossible to come up with a strict breakdown of money spent per drug. As a result, estimates vary widely.

However, if the primary job of a given company is to develop and bring to market new drugs, there is a more simplified method of viewing new drug development costs. This method involves adding up all of the R&D costs reported by a pharmaceutical company over a given period of time, perhaps many years, and then dividing that by the total number of drugs developed by that company that are approved by the FDA during that time. There are still a number of variables involved in doing this, but it represents an eye-opening window into the costs of drug development. Using this method, which factors in the number of new drug candidates that end up failing for one reason or another, the cost is arguably several billion dollars per FDA-approved drug and, in extreme cases, as high as $10 billion per FDA-approved drug.

As it turns out, the biggest cost component of all is drug failure, which is exactly what VistaGen’s stem cell technologies are designed to prevent, failure in development related to unexpected heart toxicity. A new drug can look great until it gets into human trials, or perhaps even out into the public market. At that time, unforeseen problems associated with heart toxicity or other issues, such as liver toxicity, can bring the entire program to a halt. VistaGen uses its stem cell technology-based Human Clinical Trials in a Test Tube™ platform to create viable human heart cells that a drug can be tested on in the lab, long before facing the massive expenses involved in advanced human testing and approval. With VistaGen’s technology, big Pharma can catch potential heart toxicity problems early on, making the necessary modifications in the chemical structure to rescue an otherwise effective and valuable drug candidate. It’s a win-win situation, where the pharmaceutical industry can save a literal fortune, and patients can have a better chance at getting the medications they need at a more reasonable price.

For additional information, visit the company’s website at www.VistaGen.com

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