Charleston Laboratories & Daiichi Sankyo Announce Major Collaboration

Charleston Laboratories, Inc., through its wholly owned subsidiary LOCL Pharma, Inc., and Daiichi Sankyo recently announced the parties have entered into a strategic collaboration for the development and US 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 III 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 US, with more than 131 million prescriptions annually. Opioid-induced nausea affects up to 30% of these patients, with approximately 15% 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, under the terms of the agreement, Daiichi Sankyo, Inc., the US subsidiary of Tokyo-headquartered Daiichi Sankyo Co., Ltd. (TSE: 4568), will be the exclusive commercialization partner for CL-108 in the US. 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 US.

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 US. 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, US Commercial of Daiichi Sankyo, Inc. “Daiichi Sankyo has proven success in the US 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 US, and we feel they are the ideal strategic fit for Charleston’s lead asset, CL-108.”

“Charleston is extremely pleased to enter into this exclusive US license agreement with Daiichi Sankyo,” said Paul Bosse, Founder, President and Chief Executive Officer of Charleston Laboratories. “We look forward to applying our strong clinical and regulatory capabilities toward the goal of improving patient well-being. This agreement highlights Charleston’s tenacity and our long-term commitment to build a preeminent pain company that benefits patients and shareholders alike.”

Charleston Laboratories, Inc. is a privately held, specialty pharmaceutical company focused on the research and development of novel pain products to significantly reduce the burdensome side effects related to opioid analgesics and other products. For more information, please visit www.charlestonlabs.com.

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. For more information, please visit: www.daiichisankyo.com.