NASHVILLE – Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced that it has appointed pharmaceutical industry veteran Tan Cheow Choon as Director of International Business. Based in Singapore, Choon will be primarily responsible for executing Cumberland’s initiative to expand markets for its products across Asia, including establishing, building and managing the Company’s presence there. Cumberland also reported that DB Pharm Korea Co. Ltd. (“DB Pharm Korea”), its commercial partner for Caldolor® (ibuprofen) Injection in South Korea, has submitted an application for regulatory approval of the product in that country, marking the first such submission in Asia.
Choon spent the past 17 years in a variety of senior management roles at international pharmaceutical firms, most recently with Hospira Inc. (“Hospira”), a global pharmaceutical company focused on hospital injectables. As Hospira’s Vice President of Southeast Asia, Choon managed a team of 120 individuals responsible for establishing and expanding operations in more than ten countries including Singapore, Malaysia and Korea, which he grew to a $50 million enterprise in 2010. Choon joined Hospira pursuant to the company’s 2007 acquisition of Mayne Pharma SEA Pte Ltd. (formerly known as Faulding Pharmaceuticals, or “Faulding”), and was instrumental in the successful integration of the two pharmaceutical companies in Asian markets. During his 13-year tenure with Faulding, also a global provider of injectable hospital products, Choon served in a variety of senior management, business development and marketing
capacities, playing a key role in growing Faulding’s presence in Asia.
“We are fortunate to have someone with Choon’s extensive experience in Asian pharmaceutical markets agree to lead Cumberland’s efforts to expand our presence in Asia,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “His expertise in growing acute-care injectable pharmaceuticals coupled with his broad-based knowledge of the Asian hospital market will be integral to establishing the infrastructure necessary to bring our products to this important patient population.”
Cumberland targeted South Korea as a strategic point of entry in Asia and identified DB Pharm Korea as an appropriate commercial partner for that market. In December 2009, Cumberland licensed exclusive commercial rights for Caldolor to DB Pharm Korea and the company subsequently submitted its application for regulatory approval to market the product in South Cumberland Pharmaceuticals Korea. Choon, who will be based in Singapore to more effectively manage relationships with Cumberland’s Asian partners, will be responsible for supporting DB Pharm Korea’s planned launch of Caldolor as well as other product launches in Asia.
In 2009, Caldolor became the first injectable product approved in the United States with a dual indication for treatment of pain and fever in adults. In clinical trials, Caldolor has demonstrated significant reductions in post-operative pain when compared with opioids alone while significantly reducing opioid requirements. The product has also demonstrated clinically meaningful reductions in fever compared to placebo in hospitalized patients. Designed primarily for use in the hospital setting, Caldolor is now on formulary at more than 300 U.S. medical centers.
Cumberland focuses its proprietary commercial efforts on the United States, and is executing a strategy to bring its products to global markets through license agreements with international partners. In addition to its arrangements with DB Pharm Korea, Cumberland has licensed rights to partners for Caldolor in Canada, Australia and New Zealand. Applications for regulatory approval of Caldolor in Australia and New Zealand are currently under review. Cumberland has also licensed rights to Acetadote® (acetylcysteine) Injection, its treatment for acetaminophen poisoning, in Australia and New Zealand. Acetadote was launched for commercial use in Australia in October 2010, representing the Company’s commercial entry into ex-U.S. markets.
Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in
patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, including boxed warning, visit www.caldolor.com.
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. For full prescribing information, visit www.acetadote.net.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company’s primary target markets include hospital acute care and gastroenterology. Cumberland’s product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning and Kristalose® (lactulose) for Oral Solution, a prescription laxative. The Company also recently launched Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information on Cumberland Pharmaceuticals, please visit www.cumberlandpharma.com.
Important Note Regarding Forward-Looking and External Statements
This press release contains forward-looking statements that reflect Cumberland’s current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of operations are subject to influences outside of the Company’s control. Risk factors that could materially affect results of operations include, among others, those factors discussed in Cumberland’s Annual Report on Form 10-K as filed with the SEC on March 19, 2010. There can be no assurance that results or developments anticipated by Cumberland will be realized or, even if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.