Cumberland Pharmaceuticals (Cumberland) has entered into an exclusive agreement with DB Pharm Korea for the commercialisation of Caldolor (ibuprofen) injection in South Korea. Designed to treat pain and fever in the hospital setting, Caldolor was approved by the FDA and launched by Cumberland in the US earlier this year.
As per the terms of the agreement, DB Pharm Korea is responsible for seeking regulatory approval for Caldolor in South Korea, and following approval would handle ongoing regulatory reporting, product marketing, distribution and sales in the territory.
Reportedly, Cumberland maintains responsibility for product formulation, development and manufacturing, and will provide finished product for sale. In exchange for the license to the product, Cumberland will receive upfront and milestone payments, a transfer price and royalties on future sales of Caldolor.
The company said that following the regulatory approval for Caldolor in South Korea, DB Pharm Korea would promote the product to key South Korean hospitals, through its existing sales force.
Hong Kee Lee, representative director for DB Pharm Korea, said: “We believe Caldolor can fill an unmet need in the hospital market in South Korea, and look forward to communicating its benefits to the medical community here. Cumberland’s strong clinical data and profile for use of the product should help facilitate regulatory approval and encourage widespread hospital use in our country.”