It's a mixed bag of AstraZeneca news today: The drugmaker finally won the Euro-OK for its oral cancer med Iressa. Thumbs up, yes? But the Crestor developments weren't so happy. One, a self-appointed patent watchdog group said it had evidence that Crestor's patent was invalid. Two, a JAMA study found that C-reactive protein isn't the risk factor for heart disease that it's been made out to be.
How does that last bit affect Crestor? Well, the new data calls into question the big Jupiter trial, which showed patients with extremely low LDL and CRP had a lower chance of heart attacks. That may be so, experts now say, but it doesn't mean everyone should be tested for CRP. Doh! AstraZeneca had hoped to push CRP screening so that any and all patients with high levels could be put on Crestor.
As for the patent problem, Article One Partners announced that it had a "prior art" that applies to Crestor, which means that there could be a problem with that patent. Essentially, Article One is saying that it has evidence that the technology underlying Crestor's patent was previously patented itself. Of course, that claim has to bear up under scrutiny, but Article One has been successful at getting U.S. regulators to re-examine drug patents. And AstraZeneca is already defending its rights to Crestor exclusivity; several generics makers are salivating after copycat versions of the cholesterol fighter.
But to end on a high note. Iressa nabbed an important approval in Europe, gaining authorization as a treatment for adults with locally advanced or metastatic non-small cell lung cancer whose tumors have an EGFR mutation. It's a mouthful, but it's also a glimmer of hope for the oral drug, which initially was hailed as a potential blockbuster, but then it failed a major trial and AstraZeneca withdrew its application for approval in Europe. Two new trials comparing Iressa with chemotherapy changed regulators' minds, apparently. Now the drugmaker just has to convince doctors and pathologists to look regularly for that mutation.
ALSO: AstraZeneca chief David Brennan--who's also this year's PhRMA chairman--sets out his prescription for healthcare reform in today's Washington Post. Report