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Record number of stroke and heart disease drugs in clinical trials or await approval

2/27/2009

The Pharmaceutical Research and Manufacturers of America released a report Thursday showing a record number of stroke and heart disease medications in clinical trials or awaiting Food and Drug Administration approval, with more than 300 this year, compared to 146 in 2005.


 


The period from the mid-1990s to early this decade saw a wave of new approvals of drugs for chronic conditions, including cardiovascular disease, as drug makers recognized the market's increased need for them. Over the last few years, however, new drug launches in general have declined in recent years, seriously depressing top-line industry sales growth.


 


 


The news is also good news for the generic industry as well, since the drop off in new blockbuster drug introductions in recent years has led to what many have described as the "patent cliff" period, where the number of big-branded drugs that come off patent, opening up the doors to new generic competition, is expected to shrink dramatically in the coming years.


 


 


According to IMS Health data, $131 billion worth of drugs for various conditions will lose patent protection in 2016, followed by a long period of decline.


 


 


PhRMA's report indicates that a new wave of blockbuster drugs could be on the horizon, creating new top-line growth opportunities for retail pharmacy.


 


 


It could also indicate a future surge in the generic drug industry as new drugs entering the market come off patent.


 


 


It is also an important signal to OTC and CPG companies that heart health remains very fertile ground for new item introductions, given the health profile of America.


 


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