WASHINGTON (AP) -- AstraZeneca said late Thursday the Food and Drug Administration has again extended its review of the experimental blood thinner Brilinta, the second delay this year for one of the company's potential blockbuster products.
Shares of AstraZeneca PLC fell $2.94, or 5.9 percent, to $46.29 in morning trading.
The London-based company said in a statement the agency requested a new analysis from the company's 18,000-patient study comparing its drug to the market-leading Plavix. The international study showed better outcomes for patients taking Brilinta overall, though U.S. patients actually fared worse.
The FDA did not ask the company to conduct additional studies of the drug, which could have taken millions of dollars and several years to produce.
Jefferies International analyst Jeffrey Holford said the FDA's request would push the drug's approval to the second half of 2011.
"This delay will come as a disappointment to many and may also start to raise uncertainties about the potential scale of the product's likely commercial success," Holford said in a note.
Holford added that AstraZeneca faces substantial exposure to generic competition over the next six years as patents on some of its drugs expire. Brilinta is one of the company's few upcoming products with blockbuster potential. The drug has already received European approval.
A positive decision from FDA would allow Brilinta to compete against Plavix and Eli Lilly and Co.'s Effient in the U.S. With sales of $5.6 billion, Plavix was the third-best selling drug in the U.S. last year. Lilly's drug, which launched last summer, has faced an uphill climb with weaker sales.
In July, FDA advisory committee members voted 7 to 1 to recommend the approval of Brilinta in patients with acute coronary syndrome, or blocked arteries. The FDA was first scheduled to make a decision on the drug in September, but said it needed more time for its review.
Shares of AstraZeneca PLC fell $2.94, or 5.9 percent, to $46.29 in morning trading.
The London-based company said in a statement the agency requested a new analysis from the company's 18,000-patient study comparing its drug to the market-leading Plavix. The international study showed better outcomes for patients taking Brilinta overall, though U.S. patients actually fared worse.
The FDA did not ask the company to conduct additional studies of the drug, which could have taken millions of dollars and several years to produce.
Jefferies International analyst Jeffrey Holford said the FDA's request would push the drug's approval to the second half of 2011.
"This delay will come as a disappointment to many and may also start to raise uncertainties about the potential scale of the product's likely commercial success," Holford said in a note.
Holford added that AstraZeneca faces substantial exposure to generic competition over the next six years as patents on some of its drugs expire. Brilinta is one of the company's few upcoming products with blockbuster potential. The drug has already received European approval.
A positive decision from FDA would allow Brilinta to compete against Plavix and Eli Lilly and Co.'s Effient in the U.S. With sales of $5.6 billion, Plavix was the third-best selling drug in the U.S. last year. Lilly's drug, which launched last summer, has faced an uphill climb with weaker sales.
In July, FDA advisory committee members voted 7 to 1 to recommend the approval of Brilinta in patients with acute coronary syndrome, or blocked arteries. The FDA was first scheduled to make a decision on the drug in September, but said it needed more time for its review.
