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By Brendan Pierson
July 19 (Reuters) - A U.S. judge on Tuesday refused to issuea temporary restraining order blocking the approval of newgeneric versions of AstraZeneca's blockbustercholesterol drug Crestor in the United States.
U.S. District Judge Randolph Moss in Washington, D.C. ruledthat AstraZeneca was not likely to win a lawsuit claiming itshould get seven more years of exclusive rights to the drugthanks to its recent approval to treat a rare pediatric illness.
Generic drugmakers including Novartis AG unitSandoz, Apotex and Mylan have said in court filings thatthey are prepared to launch generic versions of Crestor, whichlost patent protection earlier this month.
AstraZeneca spokeswoman Michele Meixell said in an emailedstatement the company was "disappointed" with the decision.
AstraZeneca's bid to extend its exclusivity had drawn sharpcriticism from former presidential candidate and Senator BernieSanders, a Democrat from Vermont, who along with sevenDemocratic U.S. Representatives had urged the U.S. Food and DrugAdministration in a July 7 letter not to let the company exploita "loophole."
Allergan plc has already been selling genericCrestor in the U.S. since May under a licensing agreement withAstraZeneca, and is not affected by Tuesday's order.
Crestor, which accounted for more than 20 percent ofAstraZeneca's $23.6 billion in sales last year, was approved bythe FDA for the treatment of high cholesterol in 2003.
In May, the FDA approved the addition of a new indicationfor use to the drug's label for the treatment of homozygousfamilial hypercholesterolemia in patients 7 to 17 years old. Therare genetic disease, which causes high cholesterol andsometimes heart disease, affects about one in a million people.
In June, AstraZeneca won seven years of exclusive marketingrights for the new indication under the federal "orphan drug"program. Orphan drug exclusivity is granted to new drugs or newindications of existing drugs for rare diseases, to encourageresearch that might otherwise not be profitable.
AstraZeneca then sued the FDA seeking to block finalapproval of any new generic Crestor. The company claimed thatfederal law required drugs to include all pediatric indicationson their labels.
Moss's decision on Tuesday is in line with a ruling lastyear by another judge in the same court, who allowed genericversions of Otsuka's antipsychotic drug Abilify to go on themarket even though the drug had recently been approved for arare disease.
The case is AstraZeneca Pharmaceuticals LP et al v. Burwellet al, U.S. District Court, District of Columbia, No.1:16-cv-01336. (Reporting By Brendan Pierson in New York; Editing by AlexiaGaramfalvi and Alan Crosby)
