Pediatric Exclusivity for Hospira's Drug - Analyst Blog
19 3월 2013 - 10:30PM
Zacks
Hospira, Inc.
(HSP) recently gained pediatric exclusivity from the US Food and
Drug Administration (FDA) for its injectable sedation drug,
Precedex (dexmedetomidine HCl). The FDA’s decision resulted in a
six-month extension of the period, during which Precedex’s generic
may not be cleared following its patent expiry.
Hospira stated in its press release that the FDA’s decision to
grant pediatric exclusivity to Precedex does not imply that the
sedative is approved to treat pediatrics. Precedex continues to be
approved for treating adults. Hospira’s pediatric studies on the
drug are currently under FDA review.
Hospira received further good news from the FDA regarding Precedex
when the US regulatory body cleared a premix version of the drug.
The approval of the premix version will provide doctors with a
ready-to-use drug that boasts multiple benefits for patient
care.
Although impressed by the FDA’s decisions on Precedex, we note that
Hospira on the whole is passing through a rough patch due to the
ongoing manufacturing challenges at its Rocky Mountain facility as
well as issues with the Symbiq/Plum pumps. The ongoing
manufacturing issues at its Rocky Mountain facility have hurt the
company’s earnings over the last few quarters. The issue, until
resolved, will remain a major overhang on the stock.
Manufacturing issues at the company’s other facilities, such as at
Lake Forest, McPherson, Austin and IKKT are further challenges for
Hospira.
Hospira carries a Zacks Rank #5 (Strong Sell). Not all stocks in
the medical sector are performing as poorly as Hospira. Stocks such
as CareFusion Corporation (CFN), Abaxis,
Inc. (ABAX) and Edwards Lifesciences
Corporation (EW) are well placed in the sector and carry a
Zacks Rank #2 (Buy).
ABAXIS INC (ABAX): Free Stock Analysis Report
CAREFUSION CORP (CFN): Free Stock Analysis Report
EDWARDS LIFESCI (EW): Free Stock Analysis Report
HOSPIRA INC (HSP): Free Stock Analysis Report
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