AstraZeneca has been forced to launch new safety trials of one its most important new drugs as its application for regulatory approval in the United States has ran into delays.
The Anglo-Swedish drugs group's shares plunged on news that it will miss the planned autumn launch date for Crestor, an anti-cholesterol drug, which analysts believe could be a giant seller in a country increasingly worried about obesity among its citizens.
It blamed delays at the US Food and Drug Administration, which will be two months late in deciding whether to approve the drug.
The company also said it was launching expensive new trials on high dosages of the drugs. Beyond a certain dose, side effects include a potentially fatal muscle wasting condition, and recent trials have involved giving patients progressively larger dosages. It is understood the company is to try different doses on different patients to get a clear idea of the level at which the side effects kick in.
Crestor is the latest in a class of cholesterol-lowering drugs called statins, which included Bayer's Baycol. Bayer's product was withdrawn last year after being linked with about 100 deaths.
Some analysts expressed concern yesterday that the FDA could decide to wait for the conclusions of these new studies, which is likely to extend the delay into next year.
Meanwhile, Percy Barnevik, the fallen hero of Swedish business, was re-elected as chairman of AstraZeneca yesterday, after being forced to make a humiliating public apology over the pension scandal that has engulfed him.
Board members rallied to support Mr Barnevik, who was forced last month to return more than half of a £61m pension he had paid himself on retiring as chief executive of ABB, the Swiss-Swedish engineering group where he made his name. The award had never been disclosed to the ABB board.
Mr Barnevik said: "AstraZeneca operates high standards of corporate governance and its policies and approach are spelt out clearly. I am sorry that events in recent weeks regarding another company have led some to question the suitability of my continuing as chairman."
Sir Peter Bonfield, a long-standing AstraZeneca board member, was appointed senior non-executive director last month to act as a conduit for shareholder concerns.Reuse content