Cumberland Pharmaceuticals Licenses Caldolor(R) (ibuprofen) Injection to DB Pharm Korea for Commercialization in South Korea
Press Release
Source: Cumberland Pharmaceuticals Inc.
On 9:00 am EST, Wednesday December 9, 2009
Nashville, Tenn., Dec. 9 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX - News) today announced that it has entered into an exclusive agreement with DB Pharm Korea Co. Ltd., a Korean-based pharmaceutical company, for the commercialization of Caldolor® (ibuprofen) Injection in South Korea. Designed to treat pain and fever in the hospital setting, Caldolor was approved by the U.S. Food and Drug Administration and launched by Cumberland in the United States earlier this year.
Under 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. 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.
"We are very pleased to expand our network of international partners for Caldolor with this new agreement," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "DB Pharm Korea has a strong infrastructure to handle commercialization of hospital pharmaceutical products, and we look forward to working with them toward making Caldolor available to a larger population of patients."
Following regulatory approval for Caldolor in South Korea, DB Pharm Korea would promote the product to key South Korean hospitals through its existing sales force. Used primarily in hospitalized patients who are unable to receive oral therapies, Caldolor is expected to be the first and only injectable ibuprofen product available in South Korea for the treatment of pain and fever, featuring analgesic, antipyretic and anti-inflammatory properties.
"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," said Hong Kee Lee, Representative Director for DB Pharm Korea. "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."
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.(1)
In October 2009, Cumberland Pharmaceuticals entered into an agreement with Phebra Pty Ltd. for commercialization of Caldolor in Australia and New Zealand. The Company also has an agreement with Alveda Pharmaceuticals Inc. to make the product available in Canada. Cumberland handles commercialization of Caldolor in the United States.
SOURCE: Cumberland Pharmaceuticals Inc.
surf's up......crikey
