UPDATE:Court Blocks Generic Companies' Access To Sanofi Drug
17 Agosto 2009 - 2:27PM
Dow Jones News
Companies that have or want U.S. Food and Drug Administration
approval to make generic versions of a Sanofi-Aventis SA (SNY)
chemotherapy drug called Eloxatin have been stalled by a court
order, a Sanofi spokesman said Monday.
Both Hospira Inc. (HSP) and Teva Pharmaceutical Industries Ltd.
(TEVA) - which announced only last week that they had won approval
to make versions of the drug - have confirmed they are restrained
by Sanofi's legal challenge.
Hospira noted in a regulatory filing that the Sanofi drug, which
is used to treat stage III colon cancer and advanced colorectal
cancer, garnered U.S. sales of about $1.4 billion last year.
The order from the U.S. Court of Appeals for the District of
Columbia Circuit follows an ongoing legal scrape over other
companies' rights to make versions of the drug, known generically
as oxaliplatin. A federal court in New Jersey had ruled in June
that generic companies didn't infringe upon a patent for the
drug.
But Sanofi spokesman Geoffroy Bessaud said the new court order
stops all generic versions of the drug approved by the FDA, plus
clearance for any future generics.
"We want to protect our rights," Bessaud said.
Hospira and Teva both announced on Tuesday last week that they
had won FDA approval to launch generic versions of oxaliplatin
injections in the U.S. But Hospira disclosed in the Securities and
Exchange Commission filing three days later that its approval for
oxaliplatin products had been suspended due to legal proceedings
that Sanofi launched against the FDA.
Teva has also been affected, spokeswoman Denise Bradley
confirmed.
"Teva is not shipping further product until the legal issue is
resolved," she said in an email Monday. "We are hopeful to have a
decision in the near future."
Hospira also disclosed a warning letter from the FDA relating to
problems with power cords used on drug infusion pumps, which it
recalled. But it said neither the drug delay or power cord issue
should hurt its ability to reach recently announced 2009 financial
goals, which include an increase in its full-year earnings
projection.
Morgan Stanley analyst Marshall Urist called the drug delay "a
modest negative for the stock," but he estimated that resolution
could come in "weeks."
The suspension is temporary until the court has a chance to
consider arguments on the matter that will be filed by this
Tuesday, Hospira said. It added that the issue doesn't relate to
any issues regarding the drug's safety or effectiveness.
Shares of the involved companies sank on Monday amid a
broader-market downturn. Hospira shares were recently 2.4% lower at
$39.13, while Teva shares were 1.5% lower at $50.61.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com