Hospira's Generic Cancer Drug Delayed By Sanofi Challenge
17 Agosto 2009 - 10:39AM
Dow Jones News
Hospira Inc.'s (HSP) plans to launch a generic version of the
Sanofi-Aventis SA (SNY) colon-cancer drug Eloxatin in the U.S. have
been put on hold due to a legal challenge from Sanofi.
Hospira disclosed the delay in a regulatory filing with the
Securities and Exchange Commission late Friday, only days after it
announced Food and Drug Administration approval to launch the
injectable drug, known generically as oxaliplatin.
The company 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 a raised 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."
On Tuesday last week, Hospira said it was launching generic
oxaliplatin domestically, and that it had one of the first generic
versions of the drug in solution form. Hospira noted that the drug
racked up about $1.4 billion in U.S. sales for Sanofi last
year.
Three days later, Hospira said it received notice from the FDA
that the company's oxaliplatin application was suspended due to
"legal proceedings initiated by the innovator company against the
FDA" and a court order issued in that proceeding.
The suspension is temporary until the court has a chance to
consider arguments on the matter that will be filed by Tuesday,
Hospira said. It added that the issue doesn't relate to any issues
regarding the drug's safety or effectiveness.
The drug is a treatment for patients with stage III colon cancer
and advanced colorectal cancer.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com