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The first rule to drug discovery is to get to market as quickly as possible. That means pushing the drug through clinical trials and preparing the marketing application fast, but it also means not cutting any corners that result in delays beyond what it would have taken you to do it right the first time.
Last February, the Food and Drug Administration delayed its decision on whether to approve Eliquis by three months because the companies turned in extra data the agency needed to review. It would be nice if the companies could have predicted what data the agency might need and put it in the original application, but let's give the companies a pass for that delay. The drug was given a priority review, increasing the chance that data would be requested in the last three months of the review process, when the FDA has the right to push back the decision. A six-month review plus a three-month delay is still shorter than the standard 10-month review. Human Genome Sciences' (Nasdaq: HGSI ) Benlysta, Regeneron Pharmaceuticals' (Nasdaq: REGN ) Eylea, and Pfizer's Prevnar 13 all got priority reviews, followed by delays, so it happens to the best of them. And considering Eylea's resounding success ($124 million) and Benlysta's relative disappointment ($31 million) in terms of last quarter's sales, this delay won't determine the market viability of Eliquis.
But now the approval of Eliquis has been pushed back further, seemingly because the companies couldn't get the right data to the agency. The companies said the FDA issued a complete response letter requesting "additional information on data management and verification" for one of its trials.
The companies didn't say how long it would take to get the FDA that information, but one has to presume it'll be a few months. And then there's another six-month review period. Figure an approval in early 2013 at the earliest.
In addition to Pfizer and Bristol-Myers losing money because they can't sell the drug, the delay allows Boehringer Ingelheim and Johnson & Johnson (NYSE: JNJ ) to get more established in the atrial fibrillation market without having to worry about Eliquis. Boehringer sells Pradaxa and Johnson & Johnson sells Xarelto.
Eliquis is believed to be the best of the three for atrial fibrillation, but that doesn't much matter if the drug isn't on the market. Better get hopping, Pfizer and Bristol.