Daiichi Sankyo, Charleston Laboratories to collaborate on pain products

TOKYO—Daiichi Sankyo and Charleston Laboratories Inc., a specialty pharmaceutical company specializing in the research and development of novel pain products that prevent or significantly reduce nausea and vomiting, have announced a strategic collaboration. Through this agreement, Daiichi Sankyo and Charleston Laboratories, through its wholly owned subsidiary LOCL Pharma Inc., will collaborate on the development and U.S. commercialization of Charleston Laboratories’ novel hydrocodone combination products, including CL-108. Daiichi Sankyo Inc., the U.S. subsidiary of Daiichi Sankyo Co. Ltd., will serve as the commercialization partner for CL-108 in the United States.

“Charleston is extremely pleased to enter into this exclusive US license agreement with Daiichi Sankyo,” Paul Bosse, founder, president and CEO of Charleston Laboratories, said in a press release. “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.”

Under the agreement, Daiichi Sankyo will pay Charleston Laboratories $200 million, which will be split evenly between an upfront cash payment and a near-term milestone, with the potential for up to an additional $450 million in milestone payments tied to filing and approval of Charleston Laboratories’ novel fixed-dose hydrocodone products in the United States. Charleston Laboratories will be responsible for manufacturing activities related to CL-108 and will have the right to co-promote the drug candidate and other hydrocodone products in the United States. It will also be eligible for an 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,” Dr. Mahmoud Ghazzi, global head of Development and executive vice president at Daiichi Sankyo Co. Ltd., commented in a statement.

CL-108 is currently being evaluated as a treatment for the treatment of moderate to severe acute pain and reduction of Opioid-Induced Nausea and Vomiting (OINV). The drug candidate combines 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone and 325 mg of acetaminophen. Charleston Laboratories recently concluded a Phase 3 trial of CL-108 for these indications in 465 patients, and the compound demonstrated high statistical significance in both primary endpoints related to pain reduction and OINV symptoms.

“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,” added Ryan Baker, Charleston Laboratories’ founder and chief operating officer. “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.”

While hydrocodone currently stands as the most widely prescribed medication in the United States, with more than 131 million prescriptions each year, up to 30 percent of those patients suffer from opioid-induced nausea, with some 15 percent experiencing vomiting. As a result, OINV side effects can result in poor pain control due to compliance issues or return visits and represents a sizeable healthcare cost burden.

SOURCE: Daiichi Sankyo press release