Skip to NavigationSkip to content

AstraZeneca rises on Crestor hopes

Published on 29/10/03 at 04:15pm

AstraZeneca made significant stock market gains following indications its new superstatin Crestor will receive a positive review from US regulatory authorities.

Analysts Deutsche Bank predicted the drug will be recommended for approval at a 10-40 mg dose range by a US FDA advisory committee when it meets next week.

Shares in the company rose by 3.7% to 2,495p on Thursday aided by the broker 's expectations for the drug and its assertion that shares in the company will rise still further.

Crestor is an important new product for AstraZeneca as it negotiates its way through the loss of exclusivity on its blockbuster ulcer treatment Losec. The drug is already on the market in several countries, including Canada, the Netherlands and the UK.

Concerns over its side-effects have, however, led to the drug's financial potential being dented. Next week's advisory committee meeting is expected to discuss the side-effects ahead of FDA's deadline for approval on August 12.

A spokesman for AstraZeneca said the company believed it had strong enough data to secure US approval.

"AstraZeneca is confident in the regulatory package submitted for Crestor and looks forward to presenting data from the extensive clinical trial programme demonstrating its efficacy and safety", he told Reuters.

Although analysts have predicted peak year annual sales of $3 billion for the product, regulators have been re-examining the safety of all statins after Bayer's Lipobay/Baycol product was withdrawn in 2001 because of links to serious side-effects.

Crestor's approval process was stalled last year after the FDA requested additional clinical data, which AstraZeneca submitted in February this year.

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches