Cumberland Pharmaceuticals and Phebra team up to commercialize Caldolor injection

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, today announced they have entered into an exclusive partnership for the commercialization of Caldolor® (ibuprofen) Injection in Australia and New Zealand. An intravenous formulation of ibuprofen, Caldolor is designed to treat pain and fever in the hospital setting. Cumberland Pharmaceuticals received U.S. Food and Drug Administration approval for Caldolor in June 2009.

Under the terms of the agreement, 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.

"We are pleased to partner with Phebra to make Caldolor available in Australia and New Zealand," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Phebra shares our focus on providing innovative products that improve quality of care for hospitalized 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 hospitalized patients who are unable to receive oral therapies, Caldolor would be the first and only injectable ibuprofen product available in Australia and New Zealand for the treatment of pain and fever, featuring analgesic, antipyretic and anti-inflammatory properties. More than 10 million 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 Au$32Million(1).

"We are delighted to partner with Cumberland to bring this important product to a broader, global audience," said Dr. Mal Eutick, President and Chief Executive Officer of Phebra. "Based on data resulting from clinical trials for Caldolor, we believe there is great opportunity to promote widespread usage throughout Australia and New Zealand."

A recently published study in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, entitled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen for the Management of Postoperative Pain in Adults," concluded that postoperative patients receiving Caldolor required less narcotic and experienced less pain compared to patients receiving morphine alone. The World Health Organization has recommended a multi-modal approach to pain management, with non-opioid analgesics such as ibuprofen recommended as first-line treatment(2).