A report in PharmaTimes online points to a report from Fitch Ratings, one of the Big Three credit rating agencies, warning that the U.S. Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 than it did in 2011. According to the FDA’s Center for Drug Evaluation (CDER), in 2011 the FDA approved 30 novel drugs, known as New Molecular Entities (NMEs). Although 2011 was a good year for approvals, since 2002 the FDA has averaged only slightly less than 24 NME approvals per year (23.5), even though the pharmaceutical industry has continued to pump billions of dollars into new drug research and development. The report indicates that the current slowdown began in late 2011.
Today the total cost of getting a new drug to market can easily run over a billion dollars. With the proprietary rights to existing branded drugs starting to run out, meaning a loss in market share to generic versions, pharmaceutical companies are scrambling to come up with new sources of revenue, and FDA approval remains a major hurdle. The report points to three of the industry’s 10 former best-selling medicines that have now lost market exclusivity: Pfizer’s Lipitor (the world’s top-selling drug), Eli Lilly’s Zyprexa, and Sanofi’s Plavix. In addition, Merck’s Singulair will face generic competition in August.
VistaGen is directly addressing a key issue in getting new drugs to market; unexpected heart toxicity that is often discovered only after the drug developer has already spent tremendous amounts of money and effort developing the new drug candidate. VistaGen uses advanced stem cell technology to create functioning human heart cells that provide the basis for superior bioassay systems and the cardiotoxicity testing of new drug candidates. It can tell drug developers early in the process whether there are potential heart toxicity problems, allowing them to deal with the issues before further money and time are wasted. The potential savings for the pharmaceutical industry and healthcare system are enormous.
For additional information, visit the company’s website at www.VistaGen.com
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