UPDATE: Hospira: Docetaxel Doesn't Have Final FDA Approval Yet
30 Novembro 2010 - 2:26PM
Dow Jones News
Hospira Inc. (HSP) said Tuesday that its drug Docetaxel, a
generic version of the Sanofi-Aventis SA (SNY, SAN.FR) cancer drug
Taxotere and an important growth driver for Hospira, hasn't
garnered final Food and Drug Administration approval as soon as
hoped because the agency had product-label questions.
The generic drug has tentative approval, and on Nov. 15 Hospira
said in a press release that the next item needed--the FDA's
approval for the final drug label--was expected within 10 business
days. But the FDA requested amendments to that labeling, which the
company has submitted for approval, Hospira said Tuesday.
"While Hospira cannot predict the timing for conversion of its
tentatively approved Docetaxel to final approval, Hospira continues
to work closely with the FDA to expedite this matter," the company
said in a filing with the Securities and Exchange Commission.
"Hopefully we'll get approval before the end of the year,"
Thomas Werner, Hospira's chief financial officer, added while
speaking at a Piper Jaffray health-care conference Tuesday.
Werner noted that the FDA requested certain changes to the
packaging insert and labeling, and said it appears the issue was
created by Sanofi switching to a single-vial product with double
the concentration from a prior two-vial version. A Hospira
spokesman said there isn't an issue with the drug itself, which the
company already sells outside the U.S.
J.P. Morgan analysts said this new development likely is "a more
minor delay with approval still a matter of when, not if." But if
U.S. approval for Hospira's "key growth driver for 2011" doesn't
come this year as J.P. Morgan forecasted, the delay could knock
about 10 cents off the firm's 2010 per-share earnings estimate of
$3.55, analysts said.
Hospira said in October that its adjusted $3.40 to $3.45 per
share earnings guidance for this year didn't include any
contribution from Docetaxel or another generic cancer drug called
Gemcitabine, although the company saw a chance both could launch
domestically in November. It announced the launch of Gemcitabine--a
generic version of the Eli Lilly & Co. (LLY) chemotherapy drug
Gemzar--on Nov. 15.
Hospira shares recently traded down 0.6% to $55.95, but are up
9.7% on the year.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com
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