CL-108 combines 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone and 325 mg of acetaminophen. Charleston recently completed a Phase III trial studying the effects of CL-108, which demonstrated high statistical significance.
Daiichi’s U.S. subsidiary will be the commercialization partner for CL-108 in the U.S. and Charleston will be responsible for manufacturing, and will receive the right to co-promote this and other hydrocodone products in the U.S.
Charleston Laboratories will receive $200 million, in an upfront cash payment and a near-term milestones and as much as an additional $450 million in milestones for the filing and approval of its fixed-dose hydrocodone products. Charleston will also receive an escalating share of profits from the products.
"We are proud to partner with Charleston Labs on this exciting and unique fixed-dose combination tablet, which will seek to simultaneously address severe pain and opioid-related nausea and vomiting to benefit patients," said Dr. Mahmoud Ghazzi, MD, Ph.D., global head of development and executive vice president at Daiichi Sankyo Co.
"From our inception, it has been our goal to identify an industry-leading partner that is patient-focused, with a shared appreciation for the importance of educating healthcare providers on the significant issue of Opioid-Induced Nausea and Vomiting," said Ryan Baker, founder and chief operating officer of Charleston Labs. "Daiichi Sankyo has successfully commercialized several medicines in the U.S., and we feel they are the ideal strategic fit for Charleston's lead asset, CL-108."