AstraZeneca pushes to protect Crestor from generic competition

No more than a few hundred U.S. children have a rare disease characterized by ultrahigh levels of bad cholesterol.

Yet to the giant drugmaker AstraZeneca, this small group could be worth billions of dollars.

The company is making a bold attempt to fend off impending generic competition to its best-selling drug, the anti-cholesterol pill Crestor, by getting it approved to treat the rare disease. In an unusual legal argument, the company says Crestor is entitled to seven years of additional market exclusivity under the Orphan Drug Act, a three-decade-old law that encourages pharmaceutical companies to develop treatments for rare diseases.

Critics say AstraZeneca is trying to abuse the law, since the overwhelming use of Crestor is for treating adults with high cholesterol, not children with the rare disease.

“This represents a deviation from the intent of the Orphan Drug Act,” said Dr. Martin A. Makary, a professor of health policy at Johns Hopkins Medical School. “It is now being used to dominate the market with retrofitted indications.”

Crestor, a cholesterol-lowering statin, was prescribed 20.3 million times in the United States last year, the second-most of any brand-name drug after Synthroid, a thyroid medicine, according to the prescription tracker IMS Health. The drug, also known as rosuvastatin calcium, is scheduled to lose patent protection on July 8, poten- tially exposing it to an onslaught of generic competition.

The introduction of generics would weigh heavily on AstraZeneca’s bottom line. Crestor is the company’s best-selling drug, accounting for $5 billion of its