With approval in sight, ObsEva sells regional rights to women's health drug for tiny upfront

ObsEva has found a taker for its near-approval uterine fibroid treatment linzagolix. With the oral GnRH antagonist on the cusp of approval on both sides of the Atlantic, ObsEva has sold rights to the drug in Europe and certain other territories to Theramex.

The deal grants Theramex rights to the drug outside of the U.S., Canada and Asia, positioning it to deploy its sales representatives in Europe, Brazil and Australia and third-party distributors in 60 countries to try to turn the treatment into a commercial success. Theramex will pay €5 million ($5.7 million) upon signing the agreement as part of a deal that could be worth €72.8 million if all milestones are hit.

Most of the money, €54 million, is tied to sales, with the rest linked to development and commercial milestones. As such, the near-term cost of the deal to Theramex is likely to be small, particularly in light of the advanced position of linzagolix in the pipeline. The bigger paydays will arrive if linzagolix racks up significant sales, with ObsEva securing around 35% royalties on commercial sales. 

A European Medicines Agency committee recommended the approval of linzagolix in the treatment of symptoms of uterine fibroids late last year, suggesting the authorization of the product should now be a formality. Yet, last week ObsEva said “further questions on the marketing authorisation application for linzagolix may be forthcoming, thereby extending the application timeline.” 

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If approved, linzagolix will face competition. The European Commission approved oral GnRH receptor antagonist Ryeqo in the treatment of moderate-to-severe symptoms of uterine fibroids last summer, positioning Gedeon Richter, which has rights to the drug through a deal with Myovant Sciences, to target the market. 

AbbVie also has an oral GnRH antagonist, Orilissa, on the market in the U.S. The FDA is set to decide whether to approve linzagolix in September. ObsEva is working with Syneos Health on commercialization in the U.S.