Hyloris Pharmaceuticals SA, has announced that its partner for Maxigesic IV, AFT Pharmaceuticals, has signed an exclusive license and distribution agreement with Hikma Pharmaceuticals for the U.S. commercialization of Maxigesic IV, a novel, patented, non-opioid treatment for post-operative pain.

Under the terms of the agreement with AFT, Hikma will have exclusive rights for the sales, marketing, and distribution of Maxigesic IV in the U.S. Hyloris is eligible to receive $4 million in regulatory based milestones as well as commercial milestones plus a share of any additional product-related income received by AFT in the U.S.

Hikma is a global pharma company focused on complex and differentiated branded generics and generic pharmaceuticals and is a leading supplier of injectable hospital products in the U.S. across a broad range of indications, including respiratory, oncology and pain management. The Company generated group revenue of $2.34Bn in 2020.

Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “This partnership marks a major milestone for Hyloris and represents an important step forward in bringing much needed innovation in post-operative pain management to patients and physicians in the U.S. Hikma’s large U.S. footprint, their scale, network and business values make them an ideal partner for the successful rollout of Maxigesic IV in the U.S. The misuse of and addiction to opioids is a major public health issue with nearly 50,000 deaths annually in the U.S. due to opioid-involved overdoses. There is an urgent need for safer and more effective non-opioid pain treatments in the post-operative hospital setting, and thanks to its unique, dual mode-of-action, Maxigesic IV has the potential to become a valuable pain treatment option without the side effects and risk of addiction associated with opioids.”

Globally, approximately 1.2 billion vials1 are sold per year in the non-opioid analgesic space and the market for post-operative pain is growing rapidly and is forecasted to reach $1.7 billion in 2028 in the U.S., up from $745 million in 20192. In 2019, 51 million surgical procedures were performed in the U.S. and the overall treatment of post-operative pain has not substantially improved over the past 20 years, with the misuse of opioids remaining a key public health issue. The Centers for Disease Control and Prevention estimate that the total economic burden of prescription opioid misuse in the U.S. alone is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.