Uppsala, Sweden and Pickering, Canada, August 9, 2017/CNW/ – Klaria AB (Klaria) (Parent Company, Klaria Pharma Holding AB, Stockholm OMX Nasdaq:KLAR) and Purdue Pharma (Canada) today announce they 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.
“We are very excited to enter into this collaboration with a development partner with such broad experience and expertise in the field as well as direct market knowledge and legacy,” says Dr. Scott Boyer, CEO, Klaria. “Wider patient access to naloxone is one of the goals of many health authorities throughout the world and we believe KL-00514 can provide broad access and relative ease of use for a very competitive cost.”
“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.”
Landau added: “Investing in drug development to bring value to patients has always been an integral part of Purdue Canada’s contributions to the healthcare system and to Canadian patients. In the case of KL-00514, subject to successful clinical development and subsequent approval by Health Canada, those who use diverted medications and suffer from accidental or intentional overdose may also benefit”.
KL-00514 will be co-developed by Klaria and Purdue Pharma (Canada). 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 (Canada) 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.
Both Purdue Pharma (Canada) and Klaria look forward to seeing the results of the development program at which time we will determine our ability to submit the product for approval with regulators in Canada.
About Klaria AB
Klarias develops innovative products with clear competitive advantages in the therapy areas of migraine and breakthrough cancer pain. Klaria’s products are based on a patented drug delivery film which is combined with clinically-tested and established active drugs substances. Klaria is listed on Nasdaq First North under the name KLAR. FNCA Sweden is the Certified Advisor for Klaria Pharma Holding AB. The complete company description can be downloaded from www.klaria.com
About Purdue Pharma (Canada)
Purdue Pharma (Canada) is a research-based pharmaceutical company with its headquarters, R&D operations, and manufacturing located in Pickering, Ontario. The company is a leader in the research and development of medicines for the treatment of pain and central nervous system disorders (ADHD) and a growing pipeline of prescription and over the counter products. Privately held, Purdue Pharma (Canada) is independently associated with the worldwide Purdue/Napp/Mundipharma network of companies. For more information, please visit our website www.purdue.ca
Chief Executive Officer
Sarah L. Robertson
Director of Communications
Purdue Pharma (Canada)
Pickering, ON, Canada