Charleston Laboratories and Daiichi Sankyo announced that the parties have entered into a strategic collaboration for the development and U.S. commercialization of Charleston Laboratories' novel hydrocodone combination products.
This includes 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 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone and 325 mg of acetaminophen.
Charleston recently completed a 465-patient phase 3 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 OINV1.
Hydrocodone is the most widely prescribed medication in the United States, with more than 131 million prescriptions annually.
Daiichi Sankyo will be the exclusive 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.
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 FDA filing and approval of its novel fixed-dose hydrocodone products in the United States.
Charleston Laboratories will receive escalating, tiered, double-digit share of the gross operating margin from the products, and will be responsible for supplying all product.
For further deal information visit Current Agreements (subscription required)
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