NASHVILLE, Tenn., May 11 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.
U.S.-based Cumberland Pharmaceuticals has granted an exclusive license to Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, for commercialization of Acetadote in Australia. Phebra is now preparing for the Australian launch of the product, which it expects to commence in the coming weeks.
"We are delighted to obtain TGA approval for Acetadote and to make this product available to Australian hospitals," said Dr. Mal Eutick, President and Chief Executive Officer of Phebra. "We believe that using Acetadote to treat paracetamol poisoning offers a significant clinical benefit for patients and their caregivers in comparison to alternative courses of treatment, and look forward to communicating the product's benefits to the Australian medical community."
Acetadote 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. Since Cumberland Pharmaceuticals' U.S. introduction of the product in 2004, Acetadote has become a standard of care for treating acetaminophen poisoning.
Under their agreement, Phebra is responsible for ongoing regulatory requirements, marketing, distribution and sales of Acetadote in Australia, New Zealand and the Asia Pacific while Cumberland maintains responsibility for product formulation, development and manufacturing. In exchange for the product license, Cumberland receives upfront and milestone payments, a transfer price and royalties on future sales.
"Cumberland looks forward to working with Phebra to leverage their established distribution network and hospital marketing experience to make this life-saving drug available to a broader audience," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We believe Acetadote will provide an important treatment alternative for patients in the Australian market."
Acetadote® (acetylcysteine) Injection is used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen (paracetamol), a common ingredient in many over-the-counter painkillers. It is the only approved injectable product in the United States for the treatment of acetaminophen overdose. 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. 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.