GSK withdraws regulatory filings for nausea drug Zunrisa/Rezonic; progresses deal with Ligand

UK-based drugs giant GlaxoSmithKline says that it has 'made the difficult decision to discontinue the regulatory filings for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced and post-operative nausea and vomiting.' Regulatory applications were filed in a number of countries worldwide and GSK is currently communicating with those authorities and all study investigators.

GSK has made this decision, after regulatory consultation, based on the company's assessment that significant further safety data would be required to support the registration of casopitant on a worldwide basis, which would take a considerable time to produce. Consequently, all on-going regulatory files for casopitant are being withdrawn.
Back in June, GSK received a complete response letter from the US Food and Drug Administration with regard to Rezonic (casopitant) requesting additional information, but further details of what the agency had requested were not provided.

$500,000 milestone for Ligand

Meantime, GSK has agreed to accelerate the timing of a $500,000 payment to USA-based partner Ligand that would otherwise have been required upon the identification of a new lead chemical series for advancement in its alliance with GSK. This chemical series is from a program being evaluated as a potential treatment for inflammatory indications identified through the collaboration. Including this milestone, Ligand has earned a total of $4 million from GSK in connection with the discovery of eight new leads in the collaboration.

In addition, under the amended agreement Ligand and GSK agreed to waive exclusivity on two biological targets, allowing both GSK and Ligand the freedom to pursue independent research programs with such targets in addition to the current alliance programs. Furthermore, pursuant to the amended agreement Ligand will gain full research, development and/or commercialization rights to certain targets and back-up compounds associated with the drug-screening collaboration.