ObsEva initiated a corporate restructuring to refocus its development and commercialization strategy. ObsEva believes the changes are necessary due to the commercial landscape and potential additional capital needed to fund the completion of the linzagolix clinical development program, as the FDA has notified the Company of review issues regarding deficiencies in the NDA for linzagolix for uterine fibroids.
These review issues preclude discussion of labeling and post-marketing commitments at this time. While ObsEva continues to engage in communications with the FDA, including submission of documentation as well as a plan for the provision of additional data addressing the deficiencies, the Company believes that resolution of the identified review issues may not be feasible by the September 13, 2022 target action date under the Prescription Drug User Fee Act (PDUFA). The FDA’s review of the NDA is still ongoing and ObsEva has not been informed of any final decision by the agency.
Based on this assessment, ObsEva’s Board of Directors has decided to undertake the following actions:
- Termination of the license agreement with Kissei for linzagolix;
- Planned corporate restructuring to resize the Company to be able to meet ObsEva’s other license obligations and assess strategic options with respect to pipeline development;
- Application to the Swiss court for a moratorium to facilitate the planned restructuring.
In consideration of the cost of ongoing development and the competitive impact of a potential delay in approval of linzagolix for uterine fibroids by the FDA, ObsEva has decided to terminate the license agreement with Kissei for linzagolix. Termination of the linzagolix license agreement will cause ObsEva’s licensing agreement with Theramex for linzagolix to be assigned to Kissei. Linzagolix was granted marketing authorization for the management of moderate to severe symptoms of uterine fibroids in reproductive age women over 18 years old by each of the European Commission and the UK Medicines and Healthcare Products Regulatory Agency in June 2022.
ObsEva intends to restructure its operations to support existing license agreements, namely its global license agreement with Organon for the development and commercialization of ebopiprant and its sublicense agreement with Yuyuan BioScience for the development and commercialization of nolasiban in the People’s Republic of China. In addition, ObsEva will assess strategic options with respect to pipeline development and the worldwide rights it holds for nolasiban, excluding China.
Based on an evaluation of the Company’s current assets and liabilities and cash runway, ObsEva’s Board of Directors has decided to apply to the competent court in Geneva, Switzerland, for a court-sanctioned moratorium. If granted, the moratorium will provide the Company with temporary protection against debt-enforcement and bankruptcy proceedings in Switzerland, with a view to make it possible for the Company to undertake restructuring measures under the supervision of one or more court-appointed administrators.
Consistent with ObsEva’s plans to restructure its operations, ObsEva will initiate a mass dismissal process, pursuant to Swiss law. A final decision on the extent of the restructuring will be taken following a consultation process with the Company’s employees.
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