Australian TGA approves Acetadote for treatment of paracetamol poisoning

Cumberland Pharmaceuticals Inc. ( 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."