|
 U.S. District Judge Randolph Moss in Washington, D.C. ruled that
AstraZeneca was not likely to win a lawsuit claiming it should get
seven more years of exclusive rights to the drug thanks to its
recent approval to treat a rare pediatric illness.
Generic drugmakers including Novartis AG unit Sandoz, Apotex and
Mylan have said in court filings that they are prepared to launch
generic versions of Crestor, which lost patent protection earlier
this month.
AstraZeneca spokeswoman Michele Meixell said in an emailed statement
the company was "disappointed" with the decision.
AstraZeneca's bid to extend its exclusivity had drawn sharp
criticism from former presidential candidate and Senator Bernie
Sanders, a Democrat from Vermont, who along with seven Democratic
U.S. Representatives had urged the U.S. Food and Drug Administration
in a July 7 letter not to let the company exploit a "loophole."
Allergan plc has already been selling generic Crestor in the U.S.
since May under a licensing agreement with AstraZeneca, and is not
affected by Tuesday's order.
Crestor, which accounted for more than 20 percent of AstraZeneca's
$23.6 billion in sales last year, was approved by the FDA for the
treatment of high cholesterol in 2003.
In May, the FDA approved the addition of a new indication for use to
the drug's label for the treatment of homozygous familial
hypercholesterolemia in patients 7 to 17 years old. The rare genetic
disease, which causes high cholesterol and sometimes heart disease,
affects about one in a million people.
[to top of second column] |
In June, AstraZeneca won seven years of exclusive marketing rights
for the new indication under the federal "orphan drug" program.
Orphan drug exclusivity is granted to new drugs or new indications
of existing drugs for rare diseases, to encourage research that
might otherwise not be profitable.
AstraZeneca then sued the FDA seeking to block final approval of any
new generic Crestor. The company claimed that federal law required
drugs to include all pediatric indications on their labels.
Moss's decision on Tuesday is in line with a ruling last year by
another judge in the same court, who allowed generic versions of
Otsuka's antipsychotic drug Abilify to go on the market even though
the drug had recently been approved for a rare disease.
The case is AstraZeneca Pharmaceuticals LP et al v. Burwell et al,
U.S. District Court, District of Columbia, No. 1:16-cv-01336.
(Reporting By Brendan Pierson in New York; Editing by Alexia
Garamfalvi and Alan Crosby)
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed. |
