Daiichi Sankyo Inks $650 Million Deal for Hydrocodone Combination Products

Daiichi Sankyo and the specialty pharmaceutical company Charleston Laboratories, Inc., through its wholly owned subsidiary LOCL Pharma, Inc., announced have formed a strategic collaboration for the development and US commercialization of Charleston Laboratories' 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.  . 

Under the agreement, which is pending Hart-Scott-Rodino clearance, 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 fixed-dose hydrocodone products in the United States.In addition, Charleston Laboratories will receive escalating, tiered, double-digit share of the gross operating margin from the products

Daiichi Sankyo, Inc., the US subsidiary of Tokyo-headquartered Daiichi Sankyo Co., Ltd., will be the commercialization partner for CL-108 in the United States. 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 United States. CL-108 combines 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone. and 325 mg of acetaminophen.

Source: Daiichi Sankyo

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