In accordance with the agreement, pending Hart-Scott-Rodino clearance, Charleston will receive $200 million, which will be split evenly between an upfront cash payment and a near-term milestone, and an additional $450 million in milestone payments based on regulatory filing and approval of its novel fixed-dose hydrocodone products in the United States. Hydrocodone is currently the most prescribed medication in the US, with approximately over 131 million prescriptions annually.
"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, PhD, Global Head of Development and Executive Vice President at Daiichi Sankyo Co., Ltd.
CL-108 – is a novel, fixed-dose, bi-layered tablet containing 12.5mg of immediate release promethazine with a modified release of 7.5 mg of hydrocodone and 325mg of acetaminophen. Based on a 465 –patient phase 3 trial study conducted by Charleston, CL - 108 had high statistical improvements (P<0.01) in both primary endpoints relative to pain reduction and the symptoms of OINV.
"CL-108 represents an opportunity at the intersection of innovation and patient need," said Ken Keller, President, U.S. Commercial of Daiichi Sankyo, Inc. "Daiichi Sankyo has proven success in the U.S. primary care arena, a key market for pain management, and we look forward to the potential of CL-108."
"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 Laboratories. "Daiichi Sankyo has successfully commercialized several medicines in the United States, and we feel they are the ideal strategic fit for Charleston's lead asset, CL-108."
Daiichi Sankyo currently a world leader in the primary care market will be the commercialization partner for CL-108 in the U.S. Charleston Labs will still be responsible for manufacturing CL-108 and will receive the right to co-promote this and other hydrocodone products in the United States
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