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February 16, 2010
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Recently, Cadence Pharmaceuticals, Inc. (CADX) suffered a setback when the U.S. Food and Drug Administration (FDA) refused to approve its intravenous painkiller Ofirmev because of deficiencies in its third-party manufacturing facility. The FDA, however, stated that Ofirmev is an acceptable trade name for IV acetaminophen.
The U.S. agency issued a complete response letter to the company in response to the New Drug Application (NDA) filed for the approval of intravenous (IV) acetaminophen. The agency indicated in the letter that deficiencies were found at Cadence's third party manufacturing facility during the FDA's facility inspection, completed on Feb 5, 2010. The company stated that its third party manufacturer intends to respond promptly to the findings. Furthermore, Cadence intends to ask for a meeting with U.S. regulatory authorities to ensure that the deficiencies are adequately addressed and the NDA gets approved.
However, the FDA did not cite any issues related to the safety or efficacy of the candidate, nor did it ask for any additional studies to be conducted prior to approval. As a reminder, Cadence is seeking approval to market the drug to treat pain and fever in adults and children.
Ofirmev is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used therapy for treating pain and fever in the United States. It is available in more than 600 combination and single-ingredient prescription and over-the-counter products.
The exclusive rights to Ofirmev in the United States and Canada were acquired by Cadence in 2006 from Bristol-Myers Squibb (BMY) in 2006. The drug is marketed by Bristol-Myers as Perfalgan in Europe and other parts of the world. IV acetaminophen is approved in approximately 80 countries globally, including major European markets, where it is the market leader among all injectable analgesics.
Cadence Pharmaceuticals currently has a Zacks Rank #3 (Hold), implying that the stock is expected to perform in line with the broader U.S. equity market over the next one to three months. We are Neutral on the company in the long-term as well. The Neutral recommendation implies that the stock is expected to perform in line with the overall U.S. equity market over the next six to twelve months. Therefore, we advise investors to retain the stock over this time period.
Read the full analyst report on "CADX"
Read the full analyst report on "BMY"
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