Nashville, Tenn., Dec 09, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that it has entered into an exclusive agreement with DB Pharm Korea Co. Ltd., a Korean-based pharmaceutical company, for the commercialization of Caldolor(R) (ibuprofen) Injection in South Korea. Designed to treat pain and fever in the hospital setting, Caldolor was approved by the U.S. Food and Drug Administration and launched by Cumberland in the United States earlier this year.
Under the terms of the agreement, DB Pharm Korea is responsible for seeking regulatory approval for Caldolor in South Korea, and following approval would handle ongoing regulatory reporting, product marketing, distribution and sales in the territory. Cumberland maintains responsibility for product formulation, development and manufacturing, and will provide finished product for sale. In exchange for the license to the product, Cumberland will receive upfront and milestone payments, a transfer price and royalties on future sales of Caldolor.
"We are very pleased to expand our network of international partners for Caldolor with this new agreement," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "DB Pharm Korea has a strong infrastructure to handle commercialization of hospital pharmaceutical products, and we look forward to working with them toward making Caldolor available to a larger population of patients."
Following regulatory approval for Caldolor in South Korea, DB Pharm Korea would promote the product to key South Korean hospitals through its existing sales force. Used primarily in hospitalized patients who are unable to receive oral therapies, Caldolor is expected to be the first and only injectable ibuprofen product available in South Korea for the treatment of pain and fever, featuring analgesic, antipyretic and anti-inflammatory properties.
"We believe Caldolor can fill an unmet need in the hospital market in South Korea, and look forward to communicating its benefits to the medical community here," said Hong Kee Lee, Representative Director for DB Pharm Korea. "Cumberland's strong clinical data and profile for use of the product should help facilitate regulatory approval and encourage widespread hospital use in our country."
A recently published study in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, entitled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen for the Management of Postoperative Pain in Adults," concluded that postoperative patients receiving Caldolor required less narcotic and experienced less pain compared to patients receiving morphine alone. The World Health Organization has recommended a multi-modal approach to pain management, with non-opioid analgesics such as ibuprofen recommended as first-line treatment.(1)
In October 2009, Cumberland Pharmaceuticals entered into an agreement with Phebra Pty Ltd. for commercialization of Caldolor in Australia and New Zealand. The Company also has an agreement with Alveda Pharmaceuticals Inc. to make the product available in Canada. Cumberland handles commercialization of Caldolor in the United States.
SOURCE: Cumberland Pharmaceuticals Inc.
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.
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(R) (acetylcysteine) Injection for the treatment of acetaminophen poisoning and Kristalose(R) (lactulose) for Oral Solution, a prescription laxative. The Company also recently launched Caldolor(R) (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States. Cumberland is dedicated to providing innovative products which improve quality of care for patients. The Company completed the initial public offering of its common stock in August 2009. For more information on Cumberland Pharmaceuticals, please visit www.cumberlandpharma.com.
Important Note Regarding Forward-Looking 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, however, 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 other things, market conditions, intense competition from existing and new products, an inability of manufacturers to produce Caldolor on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to pharmaceutical drug manufacturers, maintaining and building an effective sales and marketing infrastructure, government regulation, the possibility that marketing exclusivity and patent rights may provide only limited protection from competition, and other factors discussed in Cumberland's Registration Statement declared effective by the SEC on August 10, 2009. There can be no assurance that the results or developments anticipated by Cumberland will be realized or, even if substantially 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 forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
(1) World Health Organization. Pain relief and palliative care. In: Clinical Management of HIV and AIDS at District Level. New Delhi, India: WHO Regional Office for South-East Asia Web site. http://www.searo.who.int/linkfiles/publications_ch11.pdf. Updated April 26, 2006. Accessed July 15, 2009.
SOURCE Cumberland Pharmaceuticals Inc.
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