Amgen Inc. said Friday that it has filed a patent-infringement
lawsuit against Regeneron Pharmaceuticals Inc. and Sanofi SA over
their experimental cholesterol drug, alirocumab.
The suit, filed in the U.S. District Court of Delaware, comes as
Amgen and Regeneron and Sanofi race to be the first to get their
cholesterol drugs to the market.
The suit alleges that Regeneron and Sanofi are violating three
Amgen patents with alirocumab, one of an emerging group of
medicines that lower cholesterol by targeting a gene known as
PCSK.
A representative from Regeneron said the company hasn't been
served with any papers in the matter and doesn't infringe any
"valid claim" in the asserted patents.
In an attempt to speed the approval process, Regeneron and
Sanofi paid $67.5 million to acquire a special voucher held by
BioMarin Pharmaceuticals Inc. earlier this year. The voucher
entitles the holder to ask the FDA for priority review of a drug
application that would otherwise get a standard review, potentially
shortening the review process to six months from the standard 10
months.
Amgen is also seeking regulatory approval of its experimental
cholesterol drug, evolocumab. Amgen said in August that it had
submitted a new drug application to the Food and Drug
Administration.
The Amgen suit is seeking an injunction to stop the manufacture,
use and sale of alirocumab.
Write to Chelsey Dulaney at Chelsey.Dulaney@wsj.com
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