ObsEva SA (NASDA: OBSV) has announced plans to commence corporate restructuring and refocus its commercial and development strategy.
FDA points to shortfalls in ObSeva’s linzagolix NDA
The US Food and Drug Administration has informed ObsEva of review problems concerning shortfalls in the New Drug Application (NDA) for linzagolix for the treatment of uterine fibroids. ObsEva thinks the changes are necessary because of the commercial environment and prospective additional capital required to fund the finalization of the linzagolix clinical development program. Discussions of labeling and post-marketing obligations are currently off the table due to review-related concerns.
While ObsEva keeps communicating with the FDA, including by submitting documentation and a strategy for providing additional information to address the shortfalls, the management says that this might not be possible to resolve the identified review concerns by the Prescription Drug User Fee Act’s target action date of September 13, 2022. The NDA review is ongoing, and ObsEva is yet to receive a final decision.
Based on the assessment, the company’s Board o Directors has decided to terminate the license agreement with Kissei for linzagolix. The license agreement termination with Theramex for linzagolix will be assigned to Kissei. Linzagolix has marketing approval from UK and EC regulators for moderate to severe uterine fibroids treatment in women above 18 years. The company will restructure to resize to be able to meet other license obligations and assess strategic options with respect to pipeline development. Additionally, the company will assess strategic alternatives with respect to pipeline development and global rights for nolasiban, except in China.
ObsEva announces resignation of Chief Scientific Officer
The company also announced Jean-Pierre Gotteland’s resignation as the Chief Scientific Officer and Head of Research Development, effective September 30, 2022. Gotteland will equally step down from ObsEva’s executive committee effective immediately.
Brian O’Callaghan, CEO of ObsEva, stated, “On behalf of the Board of Directors, Executive Committee, and all employees, I would like to thank Jean-Pierre for his contributions to ObsEva over the past seven years. It has been a pleasure to work together and we wish Jean-Pierre all the best in his future endeavors.”