Publish Date : 11-Aug-2014
Daiichi Sankyo and Charleston Laboratories, Inc., through its wholly owned subsidiary LOCL Pharma, Inc., announced today that the parties have entered into a strategic collaboration for the development and U.S. commercialization of Charleston Laboratories’ novel 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 (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 OINV. Hydrocodone is the most widely prescribed medication in the United States, with more than 131 million prescriptions annually. Opioid-induced nausea affects up to 30 percent of these patients, with approximately 15 percent experiencing vomiting. These unwanted side effects can result in poor pain control related to difficulties with compliance or return visits to the physician or the hospital for further treatment. As a consequence, OINV poses a significant burden for patients and prescribers, while contributing significant costs to the healthcare system.
With this collaboration, Daiichi Sankyo, Inc., the U.S. subsidiary of Tokyo-headquartered Daiichi Sankyo Co., Ltd. (TSE: 4568), 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. Under the terms of the agreement, which is pending Hart-Scott-Rodinoclearance, 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 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.
“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.
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