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news.Cumberland Pharmaceuticals and Phebra's 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.
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US-based Cumberland Pharma has granted an exclusive license to Phebra, an Australian based pharmaceutical company, for commercialisation of Acetadote in Australia. Phebra is now preparing for the Australian launch of the product, which it expects to commence in the coming weeks.
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.
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.
Mal Eutick, president and CEO of Phebra, said: “We are delighted to obtain TGA approval for Acetadote and to make this product available to Australian hospitals.
“We believe that using Acetadote to treat paracetamol poisoning offers a 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.”
Kazimi, CEO of Cumberland Pharma, said: “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. We believe Acetadote will provide an important treatment alternative for patients in the Australian market.”