Update: Astra wilts on FDA delay

15th Sep 2010 07:12

No news is bad news seems to be the market's view as shares in Anglo-Swedish drugs giant AstraZeneca retreated on news that the US Food and Drug Administration (FDA) has not yet made a decision on Astra's ticagrelor blood thinning drug.The FDA said the Prescription Drug User Fee Act (PDUFA) date has been revised from 16 September 2010 to 16 December 2010. AstraZeneca was putting a brave face on things and said it will continue to work closely with the FDA to support the review of the ticagrelor new drug application, but the market regarded the three month delay as a setback.In July, the FDA's Cardiovascular and Renal Drugs Advisory Committee recommended the drug to reduce the risk of major adverse cardiac events in patients with acute coronary syndromes, though there was one dissenting voice on the eight-person committee. Ticagrelor is currently under regulatory review in nine additional territories around the world, including the European Union, Canada, and Brazil, Astra said. One of the issues that could be dogging the drug stateside, which Astra intends to market under the Brilinta brand, is the difference in effectiveness between US and non-US participants in the Phase III head to head trial with Sanofi-Aventis/Bristol-Myers Squibb's blockbuster blood thinning drug Plavix (clopidogrel). Both drugs have been tested for their effectiveness when taken in conjunction with aspirin.AstraZeneca spokeswoman Abigail Baron was quoted by trade publication PharmaTimes World News as saying that the company remained "confident in the application."Broker Jefferies International's cautious response to the FDA announcement seems to encapsulate what the market is thinking, It says that Astra is pinning a lot of hopes on Brilinta, the success of which could replace a proportion of the expected revenue loss from a number of patent expiries over the next five years. It believes success is not assured, however. "Although there was a positive panel vote in July, we remain cautious over the drug's US approval, labelling, and commercial potential," the broker said.