Women’s health drug company ObsEva recently won two regulatory approvals in Europe for its uterine fibroids drug, but the drug ran into hurdles at the FDA, so the biotech decided to drop the drug entirely.
A regulatory decision on the drug, linzagolix, is scheduled for Sept. 13. ObsEva Say On Wednesday, the FDA flagged flaws in small molecule new drug applications. The company did not describe the agency’s concerns, but said it did not believe they could be resolved by the September target date.
FDA review of linzagolix continues. However, due to the cost of continuing to develop the drug and the competitive impact of delayed regulatory decisions, ObsEva said it had decided to terminate the licensing agreement that granted the rights to the biotech’s small molecule. The next step is corporate restructuring. Geneva, Switzerland-based ObsEva also said it would take legal steps in its home country to apply for a court-approved moratorium to provide temporary protection for debt enforcement and bankruptcy proceedings. The move could make it possible for ObsEva to be restructured under court supervision.
Uterine fibroids are noncancerous growths that form in the uterus. They can cause pain and bleeding. The exact cause of these fibroids is unknown, but pharmaceutical companies are seeking ways to modulate estrogen production as a pharmacological approach to treating them. The rise and fall of hormones, especially estrogen, is thought to contribute to the development and progression of fibroids. Linzagolix is an oral drug designed to bind to and block the receptor GnRH in the pituitary gland. This approach lowers the levels of both hormones, which leads to lower estrogen levels. An FDA-approved uterine fibroids drug from AbbVie Myovant already addresses the same goal.
June 17, European Commission Approved by Linza Golix For the treatment of uterine fibroids.UK medicines regulator follow Less than two weeks later his own approval decision. The ObsEva drug is marketed in Europe under the brand name Yselty.
ObsEva has licensed linzagolix from Kissei Pharmaceutical of Japan. It has two other drugs in development. Ebopiprant is in mid-development to reduce inflammation and uterine contractions in preterm labor. The worldwide rights to ebopiprant have been licensed to Organon, and ObsEva has said it will support the agreement with the company. Depending on how the drug progresses, ObsEva could earn up to $475 million in milestone payments, as well as royalties on sales of commercialized products.
A second remaining ObsEva drug, nolasiban, is in early testing to improve pregnancy and live birth rates after IVF. Yuyuan Bio has the rights to develop and commercialize norasiban in China. ObsEva said it plans to find others to obtain rights to the drug, excluding Yue Yuen’s rights in China.
According to its annual report, ObsEva ended 2021 with a cash position of $54.7 million. The number of employees at the end of the year was 51. The company said on Wednesday that its restructuring would lead to a “mass dismissal procedure” under Swiss law.
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