With nearly 600 million people either living within its confines or about to enter them, the European Union offers the second largest pharmaceutical market in the world after the United States, due to its strong intellectual property laws and high standard of living.
Due to this large market opportunity, many pharmaceutical companies make it a priority to get their drugs approved in Europe. Last week, Rule Breakers pick CV Therapeutics
CVT first attempted to get Ranexa approved in the EU to treat chronic angina back in early 2004. Unfortunately, the European Medicines Agency (Europe's equivalent of the FDA) rejected CVT's application in October 2005 because it wanted more clinical trial data before granting CVT approval to market Ranexa.
It will most likely take the EMEA approximately seven to 10 months (seven is the minimum) to give another positive or negative opinion on Ranexa, and then another two more for the approval or rejection to be finalized. If it's approved, CVT would then have to get down to the arduous task of negotiating reimbursement rates for Ranexa with the individual EU countries, which takes another couple of months. All in all, if approved, it will be another year at minimum before Ranexa will be sold in the EU.
In 2005, Europe accounted for nearly one-third of all pharmaceutical drug sales in the world. With a $170 billion pharmaceutical drug market (about 65% the size of the U.S. market), growing at a rate of 7%, the EU could be a big boon to CVT's sales of Ranexa if it can achieve a better label than it did in the U.S.
Even though it might take a little while to hear about any possible EU marketing approval, with trial results from the Ranexa Merlin study about to be announced in the first quarter of next year, investors won't have to wait much longer to get a better idea of what sort of sales potential Ranexa will have.
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