Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced it has entered into an exclusive agreement with China's Winhealth Pharma Group for the licensing rights of Acetadote® (acetylcysteine) Injection, used to prevent or reduce liver damage resulting from acetaminophen overdose, and Caldolor® (ibuprofen) Injection, which is used to treat pain and fever in the hospital setting. The agreement will provide Winhealth licensing rights to commercialize both FDA approved drugs in China, the second largest market for pharmaceuticals in the world after the U.S. There have been patents issued for both brands in China.
Winhealth currently markets 12 pharmaceutical brands throughout China via partnerships with Boehringer Ingelheim, Novartis, Pfizer, and Roche, among others. Under the terms of the agreement with Cumberland, Winhealth is responsible for seeking regulatory approval for the two injectable brands in China and will handle ongoing regulatory reporting, product marketing, distribution and sales in China (including Hong Kong and Macau) following approval. Cumberland maintains responsibility for intellectual property, product formulation, development, and other supporting activities. In exchange for the license to the product, Cumberland will receive upfront and milestone licensing payments, as well as royalties on future sales of both drugs.
"Winhealth has grown tremendously in recent years, making them an ideal partner as we look to bring our medicines to patients in China," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are delighted that, through this agreement, Chinese hospitals will have the opportunity to improve the quality of care offered to their patients."
Cumberland has significantly expanded its international network of partners in recent years. In addition to its arrangement with Winhealth, Cumberland has licensed rights for Caldolor to partners in South Korea, Spain, and India. The Company has also licensed rights for both Caldolor and Acetadote in Australia and New Zealand.
"We are very selective in the brands we add to our portfolio," said Mr. Wang Wei, Chairman of Winhealth Pharma Group. "We believe Acetadote and Caldolor are innovative products with a strong track record and an excellent fit for the Chinese market. In addition, it ties nicely to our company's Contract Development and Commercialization Organization (CDCO) positioning and will allow us to continue our advancement in the Chinese pharmaceutical and healthcare industry."
Following regulatory approval, Winhealth will use its existing sales force to promote these injectable products throughout China. Both offer unique benefits for hospitalized patients in China.
In the U.S., Acetadote is used in 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. Acetadote has become a standard of care for treating acetaminophen poisoning in the U.S. since its introduction. Cumberland has developed a next generation formulation of the product that does not contain any stabilizing or preservative agents.
Caldolor features analgesic, antipyretic and anti-inflammatory properties and is designed for the treatment of pain and fever, primarily in hospitalized patients who are unable to receive oral therapies. In clinical trials, Caldolor has demonstrated significant reductions in post-operative pain when compared with opioids alone while significantly reducing opioid requirements.
Both brands are approved by the FDA for use in adults as well as children.