Caldolor is used primarily in hospitalised patients who are unable to receive oral therapies for pain relief and fever reduction. If approved for marketing in Canada, it would be the first and only injectable ibuprofen product available in the country for treatment of pain and fever, featuring analgesic, antipyretic and anti-inflammatory properties.
Caldolor was approved by the FDA and launched by Cumberland Pharmaceuticals in the US in 2009.
The agreement is Cumberland Pharma’s third for the international commercialisation of Caldolor. In 2009, it partnered with Phebra for the commercialisation of Caldolor in Australia and New Zealand, and DB Pharm Korea for South Korea. Cumberland manages the commercialisation of Caldolor in the US.
According to the terms of the agreement, Alveda Pharma is expected to seek Canadian regulatory approval for Caldolor and, upon approval, handle ongoing regulatory requirements as well as product marketing, distribution and sales throughout Canada.
However, Cumberland Pharma will maintain responsibility for product formulation, development and manufacturing. In exchange for the license to the product, Cumberland will receive royalties on future sales of Caldolor in addition to upfront and milestone payments as well as a transfer price.
AJ Kazimi, CEO of Cumberland Pharma, said: “Alveda Pharma’s emphasis on filling unmet and under-met medical needs along with their strong experience in marketing hospital injectables makes them an ideal partner for Cumberland. We look forward to working together to expand access to this important drug.”
Albert Beraldo, president of Alveda Pharma, said: “There is a growing body of research that supports the safety and efficacy of Caldolor for the treatment of pain and fever in adults. Due to Caldolor’s attributes and strong performance in clinical trials, we are excited to share this innovative product with physicians and patients and to continue building a strong hospital presence throughout Canada.”