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Cumberland Pharmaceuticals Inc. recently announced encouraging top-line results from a phase IV study on Caldolor (the intravenous formulation of ibuprofen) for the treatment of pain in tonsillectomy patients aged between 6 and 16 years. The study evaluated the safety and efficacy of Caldolor.

It was found that use of Caldolor leads to a statistically significant lower number of narcotic doses in post-operative patients. Caldolor also exhibited efficacy in reducing pain, nausea and vomiting.

The company is also evaluating Caldolor for use in children suffering from fever and plans to seek approval for a pediatric indication for Caldolor.

We remind investors that Caldolor is approved by the US Food and Drug Administration (FDA) had approved Caldolor for the management of mild to moderate pain, in combination with opioid analgesics for moderate to severe pain and for the reduction of fever in adults.

However, Caldolor carries a boxed warning regarding an increase in the risk of serious cardiovascular and gastrointestinal side effects. It is contraindicated for the treatment of peri-operative pain in patients undergoing coronary artery bypass graft (CABG) surgery.

The other marketed products at Cumberland Pharma are Acetadote (acetylcysteine) for acetaminophen poisoning and Kristalose, a prescription laxative.

In February 2012, the company entered into an agreement with China’s Harbin Gloria Pharmaceuticals Co., Ltd. for the commercialization of Acetadote and Caldolor in China.

We note that several pharma companies have been working on expanding their business in China. Some deals include Pfizer’s (PFE - Analyst Report) joint venture with Zhejiang Hisun Pharmaceuticals for the development, manufacture and commercialization of off-patent products in China and across the world, AstraZeneca’s (AZN - Analyst Report) joint venture with WuXi (WX - Snapshot Report) for the development and commercialization of MEDI5117 in China, Merck KGaA’s (MKGAF) acquisition of Beijing Skywing Technology Co., Ltd. and Novartis’ (NVS - Analyst Report) acquisition of a majority stake in Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

Our Recommendation

We currently have an Outperform recommendation on Cumberland Pharma. The stock carries a Zacks #2 Rank (Buy rating) in the short run.


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