AstraZeneca Plc, the U.K.'s second- largest pharmaceutical company, said Canadian generic-drug maker Cobalt Pharmaceuticals Inc. asked U.S. regulators to approve a copy of its Crestor cholesterol treatment.
Cobalt is applying to sell the treatment before the expiration of two patents, the London-based company said. AstraZeneca has 45 days to file a patent-infringement lawsuit that would stop the Food and Drug Administration from approving the application for 30 months.
Crestor, which helps reduce the artery-clogging form of cholesterol in the blood, was AstraZeneca's third-best selling product last year, bringing in $2.03 billion. The U.K. company has had four experimental medicines fail in the last two years, and needs Crestor, the ulcer pill Nexium and the schizophrenia drug Seroquel for profit growth.
``Astra's pipeline is weak, we all know that, so any suggestion that major earnings drivers might come under pressure from generics is going to hurt the stock price,'' Nick Turner, an analyst at Mirabaud Securities who rates that stock ``neutral,'' said in a phone interview. ``It's difficult to see how Cobalt could get around these patents. There's little real substance behind an early Crestor generic.''
Different Doses
Mississauga, Ontario-based Cobalt, which is applying for four different doses of the medicine, claims that its versions won't infringe on patents that expire in 2016 and in 2020, AstraZeneca said.
``AstraZeneca is evaluating Cobalt's allegations and certifications,'' said the U.K. company. ``AstraZeneca has full confidence in its intellectual property portfolio protecting Crestor.''
The U.K. drugmaker's shares declined 8 pence, or 0.3 percent, to 2,365 pence as of 10:11 a.m. in London. AstraZeneca has declined about 14 percent this year, the second-worst performance in the 13-member Bloomberg Europe Pharmaceutical Index.
AstraZeneca, scheduled to report third-quarter earnings today, is positioning itself to take a bigger share of the market for cholesterol treatments. Norwalk, Connecticut-based consulting firm IMS Health Inc. estimates the market is worth $21.6 billion- a-year, making it the biggest-selling category of drugs.
Pfizer Inc.'s cholesterol drug Lipitor, the world's best- selling medicine, will lose patent protection in 2010, and generic copies of Merck & Co.'s similar Zocor went on sale last year. |
