The female health space is facing pauses in drug development and certain treatments due to the Covid-19 pandemic. On 23 March, ObsEva provided an update regarding the impact of Covid-19 on the company’s clinical development programs.
The company stated that patient screening and randomisation in its ongoing Phase III trials of its oral GnRH receptor antagonist linzagolix for endometriosis-associated pain, EDELWEISS 2 and EDELWEISS 3, are voluntarily being paused until further notice. The Phase III trials were initiated in May 2019. Following the latest developments, enrollment may not be completed before the end of 2020, with top-line data readout potentially pushed to the end of 2021. GlobalData believes that the postponed enrollment completion in the EDELWEISS pivotal trials will subsequently delay linzagolix’s potential approval and launch in the endometriosis indication by several months, and will push initial drug sales into 2023.
This would constitute another, albeit smaller, revenue setback for the company, following the failure of its other asset, the oral oxytocin receptor antagonist nolasiban, for patients undergoing in vitro fertilization (IVF), to meet its primary endpoint in the pivotal Europe-based IMPLANT 4 trial, just as ObsEva was gearing up to file a marketing authorisation application (MAA) for the drug in Europe.
Meanwhile, also on the IVF front, the American Society of Reproductive Medicine (ASRM) issued guidance on fertility treatments during Covid-19 and called for suspension of most treatments. The guidance urges that all new treatment cycles, such ovulation induction, intrauterine inseminations (IUIs), and IVF (both retrievals and frozen embryo transfers) temporarily be suspended, though patients ‘in-cycle’ could continue treatment. The European Society of Human Reproduction and Embryology (ESHRE) has also advised women not to undergo IVF treatment during the pandemic.
According to GlobalData, more than 1,268,000 assisted reproductive technology (ART) cycles were projected to occur in 2020 across the 7MM (US, France, Germany, Italy, Spain, the UK, and Japan). With each monthly IVF treatment cycle consisting of several sequential stages involving daily self-injected hormonal preparations, GlobalData estimates that a potential pause in IVF fertility treatments lasting two to three months could lead to a noticeable drop in ART cycles for the year. This will also impact the demand for and Q2 sales of commonly prescribed drugs involved in the process. The most notable include Merck Serono’s Gonal-F (follitropin alpha), Merck’s Follistim (follitropin beta), Ferring Pharmaceuticals’ Menopur (menotropins) and Rekovelle (follitropin delta), biosimilars Bemfola (follitropin alfa) and Ovaleap (follitropin alfa), and others. Merck has announced plans to spinoff products from its female health business into an independent company.