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Cumberland Pharmaceuticals Reports Second Quarter 2011 Financial Results
Date:8/4/2011

company for certain cardiovascular indications. The development program was eventually donated to Vanderbilt University, where researchers identified ifetroban as a potentially valuable compound in treating patients for several other niche indications. Cumberland acquired the rights to the ifetroban program from Vanderbilt through Cumberland Emerging Technologies and intends to develop it for several potential indications, including as an Orphan Drug for HRS for which it will pursue seven years of marketing exclusivity.

The FDA has cleared the Company's IND for this product candidate and Cumberland has initiated a Phase II dose escalation study to evaluate Hepatoren for the treatment of HRS.  The Company has commenced manufacturing and filed patent applications to protect intellectual property related to the new indication.  Cumberland believes Hepatoren is an excellent strategic fit given the Company's established presence in the hospital acute care market.

International Markets

During the second quarter, Cumberland executed agreements with partners for commercialization of Caldolor and Acetadote in Malaysia and Taiwan. In Malaysia, the Company is partnering with Insanbakti and in Taiwan with Harvest & Health Co., Ltd.  These agreements are part of a larger initiative to secure distribution of Cumberland's products in Asian markets, and are in addition to a recent license agreement with DB Pharm Korea for Caldolor in South Korea.

The application for regulatory approval of Caldolor in Canada was recently submitted by Cumberland's Canadian partner, Alveda Pharma. Review of the application for regulatory approval of Caldolor in Australia is underway and Cumberland is working to identify additional arrangements for commercialization of its products in other markets as well.

Supplemental Financial InformationThe following table presents a reconciliation of Cumberland's net income to EBITDA. The Company defines
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SOURCE Cumberland Pharmaceuticals Inc.
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