Promethazine/hydrocodone/paracetamol

August 31, 2017 By Alex Keown , BioSpace.com Breaking News Staff TOKYO – After three years Daiichi Sankyo is calling it quits regarding its partnership with Charleston Laboratories and taking a loss of about $250 million. This morning, the Japanese firm said it will forgo further involvement with the development and commercialization of Charleston Laboratories’ hydrocodone products, including the Phase III CL-108 (hydrocodone, acetaminophen, promethazine). All rights will be returned to Charleston Laboratories. In 2014, the two companies forged a deal worth up to $650 million for Charleston Laboratories’ fixed-dose combination hydrocodone products for pain and opioid-induced nausea and vomiting. Withdrawing from the deal will cost the Japanese company about $250 million in the second quarter, Daiichi Sankyo said. That cost reflects payments made to Charleston Laboratories over past two years. An updated consolidated financial forecast reflecting that loss will be reported in Daiichi Sankyo’s next earnings call. Daiichi Sankyo said the decision to terminate the deal was made due to a refocusing of the company’s commercial efforts on its own product line in the U.S. pain franchise as well as other molecules in our pipeline. “We would like to thank Charleston Laboratories for its partnership and commitment to patients suffering with acute pain and opioid-induced nausea and vomiting. Daiichi Sankyo remains dedicated to bringing innovative medicines to patients and will continue to explore future opportunities that support our corporate strategy to expand our business and achieve long-term growth,” Ken Keller , president of Daiichi Sankyo’s administrative and commercial division, said in a statement. For its part, Charleston Laboratories is centralizing its comprehensive acute pain portfolio and accelerating the process to bring CL-108 to market, the company said this morning. Paul Bosse , president and chief executive officer of Charleston Laboratories, said the company intends to resubmit a New Drug Application to the U.S. Food and Drug Administration soon. If approved, Bosse said the drug can help the patients needing assistance with handling opioid-induced nausea. “By addressing OINV, we believe that patients will achieve proper pain relief, shortened recovery time, and fewer days on opioid medication. Through decreasing a patient’s use of opioids, we aim to reduce the risk of misuse and abuse. Charleston Laboratories is dedicated to ensuring safe and responsible prescribing and use of our opioid analgesic portfolio,” Bosse said in a statement. Approximately 40 percent of patients prescribed opioids for pain experience OINV. That translates to approximately 75 million instances of OINV in the United States each year, Charleston Laboratories said.