Daiichi Sankyo and Charleston Laboratories sign collaboration deal worth up to $650 million

Japanese drug major Daiichi Sankyo (TYO: 4568) and privately-held Charleston Laboratories, through its wholly owned subsidiary LOCL Pharma, have entered into a strategic collaboration worth a potential $650 million for the development and US commercialization of novel hydrocodone combination products.

Charleston recently completed a Phase III trial studying the effects of CL-108 as a treatment for moderate to severe acute pain and the reduction of opioid-induced nausea and vomiting (OINV), where CL-108 demonstrated high statistical significance in both primary endpoints relative to pain reduction and the symptoms of OINV. CL-108 combines 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone and 325 mg of acetaminophen.

Hydrocodone is the most widely prescribed medication in the USA, with more than 131 million prescriptions annually. Opioid-induced nausea affects up to 30% of these patients, with about 15% experiencing vomiting making OINV a significant burden for patients and prescribers, while contributing significant costs to the healthcare system.