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Cumberland Pharmaceuticals Reports Third Quarter 2010 Financial Results
Date:11/11/2010

s sNDA to the FDA for the use of Acetadote in patients with non-acetaminophen acute liver failure. The sNDA includes data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have an improved chance of survival without a transplant. The study showed that these patients can also survive a significant number of days longer without transplant, which would provide patients requiring transplant increased time for a donor organ to become available.

In May 2010, the FDA accepted the sNDA and granted a priority review with a response expected in September 2010. In August 2010, the FDA extended its review of the sNDA by three months. Cumberland now anticipates a response from the FDA regarding the sNDA in December 2010.

Launch of Acetadote in Australia

In April 2010, the Therapeutic Goods Administration granted approval to Cumberland's partner Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, for the commercialization of Acetadote in Australia. In October 2010, Phebra commenced with the Australian launch of Acetadote and began promoting wide distribution of the product. This introduction of Acetadote in Australia marked the introduction of Cumberland's products into international markets.

In addition to Australia, Phebra has exclusive marketing rights to Acetadote for New Zealand and has obtained marketing approval in that country. Phebra is also Cumberland's marketing partner for Acetadote in certain Asia Pacific markets, and continues to work toward obtaining approval for the product in those areas as well.  

SUPPLEMENTAL FINANCIAL INFORMATIONThe following table presents a reconciliation of Cumberland's net income to EBITDA and adjusted EBITDA. The Company defines EBITDA as net income plus interest, income tax, depreciation and amortization, and presents these measures to assist investors in
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SOURCE Cumberland Pharmaceuticals Inc.
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