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Charleston Laboratories and Daiichi Sankyo Announce Collaboration to Develop and Commercialize Novel, Fixed-Dose Combination Hydrocodone Products for Pain and Opioid-Induced Nausea and Vomiting (OINV) in the US
Date:8/7/2014

8 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.

Under the terms of the agreement, which is pending HSR 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 FDA filing and approval of its novel 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, and will be responsible for supplying all product.  

"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, Global Head of Development and Executive Vice President at Daiichi Sankyo.

"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 '/>"/>

SOURCE Charleston Laboratories, Inc.
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