Cumberland Pharmaceuticals (Cumberland) and Phebra have entered into an exclusive partnership for the commercialization of Caldolor (ibuprofen) Injection in Australia and New Zealand. Caldolor, an intravenous formulation of ibuprofen, is designed to treat pain and fever in the hospital setting. Cumberland received US FDA approval for Caldolor in June 2009.
As per the deal, Phebra assumes responsibility for obtaining any regulatory approval for the product, and would then handle all ongoing regulatory requirements, product marketing, distribution and sales in the territories. Cumberland will maintain responsibility for product formulation, development and manufacturing. In addition to upfront and milestone payments as well as a transfer price, Cumberland will receive royalties on future sales of Caldolor.
Kazimi, chief executive officer of Cumberland, said: “We are pleased to partner with Phebra to make Caldolor available in Australia and New Zealand.Phebra shares our focus on providing innovative products that improve quality of care for hospitalised patients and address unmet medical needs. With their strong distribution network and success in marketing hospital injectables, we believe there is significant opportunity for Caldolor to fill an important need in these countries.”
Used primarily in hospitalised patients who are unable to receive oral therapies, Caldolor would be the first and only injectable ibuprofen product available in Australia and New Zealand. More than 10m single dose units of injectable narcotic analgesics are sold into the Australian market each year, as part of a combined injectable analgesic market valued in excess of A$32m, said the company.
Mal Eutick, president and chief executive officer of Phebra, said: “We are delighted to partner with Cumberland to bring this important product to a broader, global audience.Based on data resulting from clinical trials for Caldolor, we believe there is great opportunity to promote widespread usage throughout Australia and New Zealand.”