Allergan and partner Gedeon Richter say they anticipate filing an NDA for Allergan’s uterine fibroids therapy ulipristal acetate during the second half of 2017, on the back of positive data from a second pivotal Phase III U.S. trial. The selective progesterone receptor modulator (SPRM) is marketed by Gedeon Richter in Europe under the trade name Esmya® and in Canada under the trade name Fibristal™, but has yet to be approved in the U.S.
The Venus II study involved 432 U.S. patients, randomized to receive either 5 mg or 10 mg of ulipristal or placebo. The trial met all of its co-primary and secondary endpoints, including percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding on treatment during treatment course one. A significantly greater number of patients in both the 10-mg ulipristal group of patients (54.8%) and the 5-mg ulipristal group (42.0%) achieved absence of bleeding compared with the placebo group (0%). A significantly higher number of patients in the 10-mg ulipristal group (55.4%) and in the 5-mg ulipristal group (34.6%) achieved absence of bleeding within 10 days after treatment initiation in treatment course one, compared with those in the placebo group (0.0%).
Positive data from the first Phase III U.S. Venus I trial was reported in May 2016. “We are pleased with the favorable results of Venus II supporting the efficacy and safety profile of ulipristal acetate as shown in our Venus I trial,” said David Nicholson, chief R&D officer, Allergan. “We are confident that the results of our Phase III trials for ulipristal acetate may potentially offer the first and only oral treatment option for women suffering from uterine fibroids in the U.S.”
Esmya and Fibristal are approved in their respective markets for for the preoperative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Allergan has inked a number of product and company buyout deals within the last few weeks. Earlier this month Allergan reported on a deal with Assembly Biosciences, through which it negotiated rights to four of the latter’s microbiome-founded gastrointestinal disease candidates. The firm in parallel announced the acquisition of an exclusive option to acquire Lysosomal Therapeutics, a Cambridge, MA-based developer of drugs for neurological disorders, including Parkinson’s disease. Within the last month Allergan confirmed a definitive agreement to acquire regenerative medicines firm LifeCell for $2.9 million in cash. In November 2016 Allergan completed the acquisition of Chase Pharmaceuticals Corporation, a clinical-stage biopharmaceutical company focused on the development of improved treatments for neurodegenerative disorders