Back to top

Analyst Blog

Cadence Pharmaceuticals 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 Bristol-Myers Squibb (BMY - Analyst Report) 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 now, Actelion (ALIOF) and ViroPharma Pharmaceuticals look attractive. Both stocks carry a Zacks Rank #1 (Strong Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%