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.
Cumberland Pharmaceuticals Inc.