NASHVILLE, Tenn. and SYDNEY, Oct. 14 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection, an injectable product used to treat acetaminophen (paracetamol) overdose, is now commercially available in the Australian market. Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, has an exclusive license from U.S.-based Cumberland Pharmaceuticals to market and distribute the product in Australia. Acetadote was approved for marketing earlier this year by the Australian Therapeutic Goods Administration.
"Paracetamol poisoning is an extremely serious overdose which, if not timely and accurately treated, can be life-threatening," said Dr. Mal Eutick, President and Chief Executive Officer of Phebra. "We are pleased to introduce Acetadote to the Australian medical community as an important treatment alternative to other available therapies."
Acetadote, which has been available in the United States since Cumberland's 2004 introduction of the product, is used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products.
"Acetadote has become a standard of care for treating acetaminophen poisoning in the U.S., and we are proud to work with Phebra to extend the product's benefits to the Australian medical community," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Phebra's established distribution network and marketing experience with more than 70 hospital products gives us confidence in its ability to make this life-saving drug available to a broad audience. We are also extremely pleased to mark Cumberland's entry into international markets with this important product launch."
Cumberland, which focuses its commercial distribution efforts on the U.S. market, is partnering with a growing list of international pharmaceutical companies to make its products available outside of the United States. Phebra is Cumberland's marketing partner in Australia for both Acetadote and Caldolor, Cumberland's injectable ibuprofen product.
Under the agreement between Cumberland and Phebra, Phebra is responsible for ongoing regulatory requirements, marketing, distribution and sales of Acetadote in Australia, New Zealand and the Asia Pacific. Phebra's sales force will immediately begin reaching out to hospitals to promote wide distribution of the product in Australia. Phebra has also obtained marketing approval in New Zealand and will continue to work toward obtaining approval for the Asia Pacific markets. Cumberland maintains responsibility for product formulation, development and manufacturing, and for providing Phebra with finished product, labeled and packaged for its specific territories. In exchange for the product license, Cumberland receives upfront and milestone payments, a transfer price and royalties on future sales.
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, 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 on Cumberland Pharmaceuticals, please visit the company website at www.cumberlandpharma.com.
Phebra Pty Ltd. is an Australian based specialty pharmaceutical company that develops and markets critical medicines in Australia, New Zealand, Asia, Canada and parts of Europe. Phebra specialises in the development, manufacture, marketing and distribution of innovative medicines for the hospital market, with focus in nine therapeutic areas including antidotes, oncology and pain. The company is dedicated to providing high quality medicines for serious and life-threatening conditions and to meeting the needs of the hospital specialty pharmaceutical market. For more information about Phebra please refer to the company website at www.phebra.com.
Important Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that reflect Cumberland's and Phebra's current views with respect to future events, based on what they believe 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 companies' 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 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 related to the companies, including those set forth 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 19, 2010. There can be no assurance that the results or developments anticipated by Cumberland and Phebra 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 and Phebra undertake 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.
SOURCE Cumberland Pharmaceuticals Inc.