AstraZeneca PLC's (AZN) new blood-thinning drug Brilinta has again failed to win approval from U.S. regulators, jeopardizing new revenue the group needs to offset the impact of expiring patents on some of its top- selling products.
The U.K.-based company is the European drug maker most exposed to losing patent protection for key medicines and Brilinta, a new heart drug, is AstraZeneca's key pipeline product.
But hopes of getting Brilinta to market soon were dashed Friday when the U.S. Food and Drug Administration asked for more information about a key study on the medicine.
The setback will seriously delay the product's launch in the world's biggest pharmaceuticals market and prompt downgrades in broker revenue estimates for the U.K. drug maker.
Jefferies said it now expects the drug's arrival in the U.S. to be delayed by at least six months, jeopardizing around $200 million of AstraZeneca's estimated sales for next year.
"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," the broker said.
Brilinta, like the market's leading anticlotting drug Plavix, is designed to keep blood platelets from sticking together in order to prevent blood clots that can lead to heart attacks and strokes. Plavix is marketed by Sanofi-Aventis SA ( SNY) of France and U.S.-based Bristol-Myers Squibb Co. (BMY).
AstraZeneca won marketing approval in Europe earlier this month for Brilinta and investors had generally expected a similar vote from the U.S. FDA. However, the U.S. regulator, which in September put off a decision on whether to approve Brilinta because it wanted more time to consider the evidence, said it now wants more details on the Plato study into the drug.
Results from AstraZeneca's Plato study, which included 18,624 patients who had been treated for a heart attack or worsening chest pain, showed that Brilinta was generally more effective than Plavix.
However, there have been some concerns that Brilinta doesn't work as well in American patients as it does in those overseas.
AstraZeneca said the FDA hadn't requested additional studies, including clinical trials, before they approve the drug. It said it's evaluating the FDA's "complete response letter" and will provide the additional analysis of the Plato data as soon as possible. It said it remains confident about its submission and its ability to meet the FDA's requests.
However, the news of the further delay hit AstraZeneca's shares, sending them down more than 6% in morning trade. At 1235 GMT they were down 181p at 2972p, a 5.7% decline and the biggest fall on the FTSE 100.
"While it is difficult to speculate regarding the exact nature of the FDA's requests, there is a high likelihood that it will be regarding the data from the U.S. cohort and the role of high dose aspirin in generating the U.S. data," said brokerage Shore Capital said in a note.
Brokerage Seymour Pierce said the news demonstrates that AstraZeneca is having difficulties with the U.S. regulatory environment. "We remain of the opinion that the impact of development and regulatory risk is under-estimated by the market," it said.
Investors will be very keen to get an update on Brilinta's prospects when AstraZeneca reports fourth-quarter results on Jan. 27.
Source: Dow Jones
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