Brilinta rejection adds to AstraZeneca's patent expiration woes

The news last week that regulators want to see more data analysis from a late-stage trial of AstraZeneca's potential blockbuster Brilinta could mean a serious setback for the pharma company. While almost all big drug developers are facing patent and sales losses over the next several years, AstraZeneca is expected to suffer more than most. As the Wall Street Journal notes, AstraZeneca could see up to a quarter of its sales disappear by 2015 thanks to patent losses. The developer hopes that Brilinta, with its projected $2.7 billion in sales by 2015, could offset some of the exclusivity losses.

AZ believes it can answer the FDA's questions and avoid the need for another trial. But Brilinta's delay further demonstrates the agency's growing scrutiny of new drugs. "The probability of success for developing new chemical compounds has fallen from 12 percent a decade ago to 8 percent today, and still is declining," notes the WSJ. "Clinical trials must be up to twice as large. Drug development costs are rising." Concerns about higher hurdles for developers have depressed pharma stock valuations, which are just 11 times estimated 2011 earnings, according to the WSJ.

- here's the Wall Street Journal article