(Adds further detail on lawsuit, statement from Sanofi,
background on EpiPen)
By Nate Raymond
April 24 France's Sanofi SA on Monday
sued Mylan NV, accusing the pharmaceutical company of
engaging in illegal conduct to squelch competition to its EpiPen
allergy treatment, which has been at the center of a public
debate over drug prices.
In a lawsuit filed in federal court in Trenton, New Jersey,
Sanofi said Mylan caused it to lose hundreds of millions of
dollars in sales by erecting barriers to U.S. consumers' access
to and use of a rival product, Auvi-Q.
In particular, Sanofi said Mylan offered rebates to
insurers, pharmaceutical benefit managers and state Medicaid
agencies conditioned on Auvi-Q not being an epinephrine
auto-injector device they would reimburse for use by consumers.
Sanofi had introduced the Auvi-Q in 2013 to treat
anaphylaxis in patients who are at risk of or have a history of
the potentially fatal allergic reaction. The company ceased
marketing the product in 2015 following a recall.
In a statement, Sanofi sought damages, which under U.S.
antitrust law would be tripled, for Mylan's conduct in the
market for epinephrine auto-injectors.
"At the time when Sanofi was marketing Auvi-Q, Mylan engaged
in illegal business practices to block a new and innovative
product from competing against their best-selling epinephrine
auto-injector, harming customers who sought to switch to Auvi-Q
and harming Sanofi," Sanofi said.
Mylan did not immediately respond to a request for comment.
The EpiPen, which Mylan acquired in 2007, is a handheld
device that treats life-threatening allergic reactions by
automatically injecting a dose of epinephrine.
Mylan came under fire beginning last year for raising the
price of a pair of EpiPens to $600 from $100 in 2008 and listing
it with Medicaid as a generic product even though it is listed
with the U.S. Food and Drug Administration as a branded one.
The U.S. company, which is registered in the Netherlands,
now sells a $300 generic version.
In January, Mylan said the U.S. Federal Trade Commission had
opened an investigation of the EpiPen after the U.S. Senate
Judiciary Committee asked the agency to look at whether it
violated antitrust law.
In September, Mylan said it agreed to a $465 million
settlement with the U.S. Justice Department over how the drug
was classified for government buyers. The department has not
confirmed the settlement.
(Reporting by Nate Raymond in Boston; Editing by Lisa Von Ahn)