Women’s health pharmaceutical company ObsEva recently welcomed two regulatory approvals in Europe for its uterine fibroids drug, but that pill has hit a wall at the FDA so the biotech has decided to walk away from the drug altogether.
The drug, linzagolix, was set for a regulatory decision by Sept. 13. ObsEva said Wednesday that the FDA has flagged deficiencies in the small molecule’s new drug application. The company did not describe the agency’s concerns but said that it believes it might not be possible to resolve them by the September target date.
The FDA’s review of linzagolix is continuing. However, citing the cost of continuing to develop the drug and the competitive impact of a delayed regulatory decision, ObsEva said it has decided to terminate the licensing agreement that gave the biotech the rights to the small molecule. The next move is a corporate restructuring. Geneva, Switzerland-based ObsEva also said it will pursue legal measures in its home country by applying for a court-sanctioned moratorium that provides temporary protection against debt enforcement and bankruptcy proceedings. The move could make it possible for ObsEva to restructure under court supervision.
Uterine fibroids are non-cancerous growths that form in the uterus. They can lead to pain and bleeding. The exact cause of these fibroids is not known, but drug companies are pursuing ways of regulating estrogen production as a pharmacological approach to treating them. The rise and fall of hormones, particularly estrogen, is thought to contribute to the development and progression of uterine fibroids. Linzagolix is an oral drug designed to bind to and block a GnRH, a receptor in the pituitary gland. This approach reduces levels of two hormones, which in turn leads to a reduction in estrogen levels. FDA-approved uterine fibroid drugs from AbbVie and Myovant already address the same target.
On June 17, the European Commission approved linzagolix for treating uterine fibroids. The U.K.’s drugs regulator followed with its own approval decision less than two weeks later. The ObsEva drug is marketed in Europe under the brand name Yselty.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
ObsEva had licensed linzagolix from Japan-based Kissei Pharmaceutical. It has two other drugs in its pipeline. Ebopiprant is in mid-stage development for reducing inflammation and uterine contractions in preterm labor. Global rights to ebopiprant were licensed to Organon, and ObsEva said it will support its agreement with that company. Depending on the drug’s progress, ObsEva could earn up to $475 million in milestone payments, plus royalties from sales of a commercialized product.
The second remaining ObsEva drug, nolasiban, is in early-stage testing for improving pregnancy and live birth rates following in vitro fertilization. YuYuan Bioscience holds the rights to develop and commercialize nolasiban in China. ObsEva said it plans to find someone else to pick up the rights to that drug, excluding YuYuan’s rights in China.
ObsEva finished 2021 with a $54.7 million cash position, according to its annual report. The headcount at the end of the year was 51. The company said Wednesday that its restructuring will lead to a “mass dismissal process” in accordance with Swiss law.
Photo: FotografiaBasica, Getty Images
