AstraZeneca has won U.S. approval to market its cholesterol-lowering drug Crestor to treat the clogging of arteries, which may boost sales of the blockbuster drug in an increasingly competitive market.
Crestor is the first of the widely used statin family of cholesterol drugs -- the world's top-selling medicines -- to win approval to treat atherosclerosis.
The news is a welcome fillip for Britain's second-biggest drug company, which earlier this week suffered a setback in a clinical trial of Crestor in heart failure patients. The company also faces a generic challenge to key patents on the medicine.
AstraZeneca shares initially rose on the news on Friday but fell back as Citigroup cut its price target for the stock, due to concerns about slowing growth for key products.
AstraZeneca views Crestor as a vital growth driver for the business in the years ahead and has been running a major program of clinical trials to try to prove its superiority to other similar statin drugs.
"This new indication gives Crestor an important differentiator from competitors in the cholesterol-lowering marketplace," AstraZeneca said in a statement.
More specifically, the approval could give Crestor an edge over other potent cholesterol fighters such as Lipitor from Pfizer and Vytorin sold by Schering-Plough and Merck .
"FDA today approved Crestor as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total-C (cholesterol) and LDL-C to target levels," U.S. Food and Drug Administration spokesman Christopher Kelly said.
Statin drugs work to reduce levels of low-density lipoprotein (LDL), or so-called bad cholesterol.
Not all analysts, however, were convinced the enhanced label would make a major difference.
"We are not optimistic that the atherosclerosis claim will be sufficient to drive significant Crestor market share gains," Citigroup analyst Kevin Wilson said in a note.
Wilson also cut his forecast for AstraZeneca earnings and reduced his share price target to 23.75 pounds from 26.50, reflecting recent decelerating growth for key drugs Nexium, Seroquel and Arimidex, as well as Crestor.
That knocked the shares, which were down 0.8 percent at 21.63 pounds -- a two-year low -- after an earlier high of 22.05.
Crestor, which AstraZeneca licensed from Japan's Shionogi, had initially had been hampered by safety concerns.
Sales have since taken off, reaching $2 billion worldwide in the first nine months of 2007, with the amassing of generally positive data from clinical trials and the absence of any new safety red flags.
Shares in Shionogi, which receives royalties on the drug, ended 2.3 percent higher at 2,000 yen after the news compared with a 1.2 percent decline for Nikkei benchmark average.
AstraZeneca disclosed last week that Canada's Cobalt Pharmaceuticals was seeking U.S. regulatory permission to sell a generic version of Crestor in a move threatening sales of the product, although not for three years or so.
Many analysts viewed the challenge as opportunistic and AstraZeneca itself said it was confident in various key patents defending the product, which run until 2016, 2020 and 2021.