Now that the FDA has refused to approve its new Brilinta bloodthinner, the AstraZeneca team may regret choosing that name. In any event, the agency issued a so-called complete response letter and wants more analysis of a key clinical study, although there was no request for addtional trials as a prerequisite for possible approval (see the statement).
The move - which hits AstraZeneca just as patents are due to expire on such best sellers as the Nexium heartburn pill and Seroquel schizphrenia treatment - is a bit of a shocker to Wall Street, given that Brilinta was already approved in Europe and, moreover, an FDA advisory panel last summer voted 7-to-1 to recommend marketing approval (back story). In fact, FDA approval had already been delayed since last September, suggesting a favorable ruling was in the cards.
In retrospect, however, a mysterious aspect to the key clinical trial should have raised doubts. That trial compared Brilinta to Plavix in 18,624 patients in 43 countries who were being treated for a blocked artery or heart attack. The results showed the med reduced heart attacks, strokes and cardiovascular death 16 percent compared with Plavix after a year’s treatment. And all patients were given aspirin.
But about 9 percent of the patients - all of whom were from the US - saw no benefit. The FDA tried to explain the difference by suggesting the aspirin dosage given US patients was higher, but there was no clear understanding, as the panel grappled with differing methods for treating patients beyond aspirin dosing. And so now, Wall Street wags are scrambling to forecast the fallout, which is expected to result in a delay of at least 12 months.
"As the most important product in AstraZeneca's pipeline, the magnitude of the delay will be critical to Brilinta's success in the US, given the expected introduction of Plavix generics" in spring 2012, assuming the FDA grants a six-month pediatric extension and competition from a forthcoming Merck bloodthinner, writes Leerink Swann analyst Seamus Fernandez, in an investor note. "While Brilinta still has the potential to achieve blockbuster sales outside the US over time, we expect a slow launch given the wide availability of generic Plavix in Europe." He predicts US sales of $1 billion by 2016.
Meanwhile, Sanford Bernstein analyst Tim Anderson strikes a pessimistic tone. "How much of a negative depends exactly on what issues FDA has with Brilinta," he writes this morning. "It remains a possibility that patients in the US are treated differently than those outside of the US, and for some reason, this parlays into Brilinta being not as good as Plavix, the current gold standard.
"It could be that AstraZeneca is trying to negotiate as favorable a label as possible, with the sticking point being what was seen with US patients and how this should be described...We think that between a US label that is not going to look great, the current availability of generic Plavix in Europe, and the May 2012 scheduled availability of generic Plavix in the US, Brilinta will ultimately fall short of consensus estimates." His forecast calls for $900 million in sales in 2015.