AstraZeneca - Brilinta

The company: AstraZeneca
The drug: Brilinta
Sales: $24 million for Q3

Expectations for Brilinta were high as AstraZeneca ($AZN) eyed FDA approval in late 2010. The blood thinner was expected to find a big niche among patients who either weren't helped by or couldn't tolerate Plavix, the standard therapy from Bristol-Myers Squibb ($BMY) and Sanofi ($SNY). It also had some particular advantages over the older drug and its other direct competitor, Eli Lilly's ($LLY) Effient. Analysts were looking at $2.7 billion in sales by 2015.

But FDA threw a big wrench in the works. Rather than ushering Brilinta onto the market as AZ hoped, the agency asked for another round of data analysis. And the seeds of doubt were sown. By the time Brilinta finally won the FDA's blessing in July 2011, analysts were cutting their expectations left and right. Many still expected the drug to build up to blockbuster status. But it had lost more than 6 months. Its time to gain market share from Plavix was sorely limited.

What Brilinta needed was a quick, solid launch onto the market, so that it could have a strong position by the time Plavix lost patent protection in May 2012. That didn't happen. While the drug managed to generate $15 million for 2011's third quarter, sales dropped back to $5 million for the final quarter of the year--and its U.S. sales for that period were virtually nil.

The company has managed to keep Brilinta on an upward trajectory this year; sales were $9 million, $18 million and $24 million for the first, second and third quarters. But now, Brilinta is fighting ultracheap Plavix copycats. AstraZeneca does have some clinical data to support Brilinta over Plavix in some patients. It's just that the story is a lot harder to sell when you're wooing patients away from a commoditized pill rather than a similarly priced brand.

Bernstein & Co. analyst Tim Anderson has put it quite simply: Brilinta was "one of the more disappointing new drug launches in the drug industry."

AstraZeneca's new CEO, Pascal Soriot, may not go as far as that. But Soriot does admit that the company "may not have shown our best game as we launched Brilinta." Still, Soriot believes Brilinta can be redeemed, Plavix generics notwithstanding. "I still think there is time to correct course," he told Reuters.

For more:
AZ puts Brilinta up for another head-to-head fight with Plavix
AstraZeneca wins FDA approval for blockbuster hopeful Brilinta
AZ's blockbuster Brilinta runs into FDA roadblock

AstraZeneca - Brilinta
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