NASHVILLE – Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today announced it has entered into an exclusive agreement with China’s Harbin Gloria Pharmaceuticals Co., Ltd. (SHE:002437) for the commercialization of Acetadote (acetylcysteine), its injectable drug used to treat acetaminophen overdose, and Caldolor (ibuprofen) Injection, which is used to treat pain and fever in the hospital setting. The agreement will provide Harbin Gloria exclusive rights to register and commercialize both drugs in China.
Pictured at left: Hong Bing Yang, CEO, Harbin Gloria, and A.J. Kazimi, chairman, CEO and principal financial officer, Cumberland Pharmaceuticals.
Under the terms of the agreement, Harbin Gloria is responsible for seeking regulatory approval for the two injectable products in China, and would handle ongoing regulatory reporting, product marketing, distribution and sales in the territory following approval. Cumberland maintains responsibility for the intellectual property, product formulation, development and other supporting activities. In exchange for the license to the product, Cumberland will receive upfront and milestone licensing payments, as well as royalties on future sales of both drugs.
“We are delighted to partner with Harbin Gloria Pharmaceuticals to expand the global presence of these products and improve the quality of care available to hospitalized patients in China,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “Expanding into new international markets is a key component of our growth strategy, and this partnership represents an important milestone in achieving that strategy and establishing a strong presence in Asia.”
While Cumberland focuses its proprietary commercial efforts on the United States, the Company has significantly expanded its international network of partners in recent years. In addition to its arrangement with Harbin Gloria, Cumberland has licensed rights for Caldolor to partners in South Korea, Malaysia, Dubai, Canada, Australia and New Zealand.
“Both of these drugs fill an important need and we are pleased to partner with Cumberland to make them available to the hospital market and patients in China,” said Zhu JiMan, Chairman of Harbin Gloria Pharmaceuticals. “We are encouraged by the strong clinical data and FDA approval of both products in the U.S. and look forward to securing regulatory approval and formally launching these products in our country.”
Following regulatory approval, Harbin Gloria will use its existing sales force to promote these injectable products throughout China. Both offer unique benefits not currently available to hospitalized patients in China. In the U.S., Acetadote is used in emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counterpain relief and fever reducing products. Acetadote has become a standard of care for treating acetaminophen poisoning in the U.S. since its introduction in 2004.
Harbin Gloria is expected to introduce the first injectable ibuprofen product in China. It features analgesic, antipyretic and anti-inflammatory properties and is designed for the treatment of pain and fever, primarily in hospitalized patients who are unable to receive oral therapies. In clinical trials, Caldolor has demonstrated significant reductions in post-operative pain when compared with opioids alone while significantly reducing opioid requirements.
SOURCE: Cumberland Pharmaceuticals Inc.
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.
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® (acetylcysteine) Injection for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States; and Kristalose® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information, please visit the company website at www.cumberlandpharma.com.
About Harbin Gloria Pharmaceuticals
Harbin Gloria Pharmaceuticals focuses on the research, development, and commercialization of injectable drugs in a variety of categories including antibiotics, medical nutrition, orthopedics, rheumatology, oncology, gastroenterology and cardiovascular medicine. Established in 2000, the Company is based in Harbin, China, and primarily sells its products throughout China’s hospital market. For more information, please visit www.gloria.cc.
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 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 Acetadote on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to drug manufacturers, maintaining and building an effective sales and marketing infrastructure, government regulation, the possibility that patent rights may provide only limited protection from competition, and other factors related to the Company including those under the headings “Risk factors” and “Management’s discussion and analysis of financial condition and results of operations” in Cumberland’s Form 10-K filed with the SEC on March 11, 2011. There can be no assurance that the results or developments anticipated by Cumberland will be realized or, if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on 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.