Swedish Klaria and Canadian Purdue Pharma have entered into exclusive development and license and supply agreements for KL-00514 (Naloxone Buccal Film).
KL-00514 is a developmental stage formulation of naloxone intended for acute treatment of intentional or accidental opioid overdose designed to give a rapid and reliable response in patients while providing a compact dosage form that could be distributed widely to patients, caregivers and emergency personnel.
KL-00514 will be co-developed by Klaria and Purdue Pharma. The development program will include formulation selection and optimization, pre-clinical studies and clinical trials. The development agreement includes exclusive global license options for the independently associated Purdue/Napp/Mundipharma network of companies upon achievement of defined milestones. Purdue Pharma will pay Klaria a combination of upfront, milestone, success-based payments plus a royalty on sales. Further terms of the agreements give Klaria exclusive manufacturing rights to supply the global market with KL-00514.
Staged, success-based payments during the development phase and registration and approval process will total approximately $2.3 million USD. Klaria will also receive income from the resulting sales of KL-00514 as a combination of royalties on sales and possible income from the exclusive supply of the product. These payments are currently estimated, as a percentage of sales, to be in the mid- to high-single digit range. Upfront and royalty amounts for other markets for KL-00514 will be agreed separately for each market.
“Collaborating on the development of KL-00514, a product designed to specifically address opioid overdose, is another concrete step we are taking to address a serious public health issue Canadians are facing,” says Dr. Craig Landau, President and CEO, Purdue Pharma (Canada). “Prescription opioid medicines remain a safe and effective treatment option for patients who are appropriately selected and monitored; however, these medicines have risks. It is our goal to provide access to life-saving treatments that support the combined efforts of regulators and governments of all levels to make treatments for intentional or accidental overdose as broadly available as possible.”
Image showing Scott Boyer, CEO of Klaria