UPDATE 2-AstraZeneca infant lung drug faces U.S. delay
(Updates with analyst comment, share price)
LONDON, Nov 28 (Reuters) - AstraZeneca Plc (AZN.L) faces a delay in getting a new infant lung drug from its recently acquired MedImmune biotech unit to market in the United States.
The Anglo-Swedish drugmaker said on Friday it had received a so-called "complete response letter" from the U.S. Food and Drug Administration (FDA) asking for additional information on motavizumab.
The move will delay approval of the antibody drug for preventing serious respiratory syncytial virus (RSV), but the company said it was confident it could respond to the outstanding questions and did not expect to have to conduct further clinical trials.
"MedImmune will continue discussions with the FDA reviewers and, subject to this dialogue, currently expects to resubmit in the first half of 2009," AstraZeneca said in a statement.
WestLB analyst Simon Mather said the FDA decision could delay the launch of the product by 18 months. He sees peak annual sales potential for motavizumab of $1.25 billion.
Motavizumab is a successor to MedImmune's existing medicine Synagis for RSV, a serious condition which affects around 125,000 infants in the United States each year.
Clinical tests suggest the new drug is more effective in reducing hospitalisations than the older product, which is expected to remain an important seller for the time being, since its patent does not expire until 2015.
AstraZeneca did not give details about the FDA questions on motavizumab, but Mather said they could be related to safety, as skin rashes were seen in some infants in the Phase III trial of the medicine.
Shares in AstraZeneca were 2 percent higher in early trade, in line with UK rival GlaxoSmithKline Plc (GSK.L) and a firmer market for European drug stocks.
AstraZeneca bought MedImmune for $15.6 billion last year to bolster its pipeline of new medicines and increase its presence in the fast-growing biotechnology sector. Many analysts said at the time it had overpaid for the business. (Reporting by Ben Hirschler; Editing by Rupert Winchester)
