Daiichi Sankyo and Charleston Laboratories, through its wholly owned subsidiary LOCL Pharma, have entered into a strategic collaboration for the development and U.S. commercialization of Charleston Laboratories’ novel hydrocodone combination products, including CL-108, being studied for the treatment of moderate to severe acute pain as well as the reduction of opioid-induced nausea and vomiting (OINV).
CL-108 combines 12.5mg of immediate-release promethazine with 7.5mg of hydrocodone and 325mg of acetaminophen. Charleston recently completed a 465-patient, phase III trial studying the effects of CL-108 as a treatment for moderate to severe acute pain and the reduction of OINV, where CL-108 demonstrated high statistical significance (P<0.01) in both primary endpoints relative to pain reduction and the symptoms of OINV.
Hydrocodone is one of the most widely prescribed medications in the U.S., with more than 131 million prescriptions annually. Opioid-induced nausea affects up to 30% of these patients, with approximately 15% experiencing vomiting. These unwanted side effects can result in poor pain control related to difficulties with compliance or return visits to the physician or hospital for further treatment. As a consequence, OINV poses a significant burden for patients and prescribers, while contributing significant costs to the healthcare system.
Daiichi Sankyo, the U.S. subsidiary of Tokyo-headquartered Daiichi Sankyo Co., will be the commercialization partner for CL-108 in the U.S. Charleston Laboratories will be responsible for manufacturing activities for CL-108 and will receive the right to co-promote this and other hydrocodone products in the U.S.
Charleston Laboratories will receive $200 million, split evenly between an upfront cash payment and a near-term milestone, and up to an additional $450 million in milestone payments connected to the filing and approval of its novel, fixed-dose hydrocodone products in the U.S. In addition, Charleston Laboratories will receive an escalating, tiered, double-digit share of the gross operating margin 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 OINV to benefit patients,” said Dr. Mahmoud Ghazzi, M.D., Ph.D., global head of development and executive vice president at Daiichi Sankyo Co.