) received a major setback when the U.S. Food and Drug
Administration (FDA) asked it to add a "black box" warning to the
label of Ofirmev injection.
The "black box" warning will include information regarding
doses and the risk of liver injury associated with doses that
exceed the recommended daily limit.
We note that Ofirmev is Cadence Pharma's proprietary
intravenous formulation of acetaminophen. It is indicated to
relieve pain with adjunctive opioid analgesics as well as for the
reduction of fever.
The exclusive rights to Ofirmev in the U.S. and Canada were
acquired by Cadence Pharma from
) in 2006. The drug is marketed by Bristol-Myers as Perfalgan in
Europe and other parts of the world.
Ofirmev is Cadence Pharma's sole approved product and the news
of a label warning is a big disappointment for the company.
Shares reacted negatively to the news and lost 3.02%. The
inclusion of the warning to Ofirmev label will adversely impact
sales in the forthcoming quarters.
We remind investors that Cadence Pharma upped its 2013 revenue
guidance in Jul 2013 based on strong Ofirmev sales in the first
half of 2013. Net revenue for Ofirmev is projected in the range
of $103.0 - $105.0 million for 2013, up from the earlier guidance
range of $97.0 million - $103.0 million.
However, the company might fall short of its projected range
given the inclusion of label warning.
Cadence Pharma currently holds a Zacks Rank #3 (Hold). Right
) look attractive. Both stocks carry a Zacks Rank #1 (Strong
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