Allergan plus partner Gedeon Richter say they anticipate filing a good NDA for Allergan’ s uterine fibroids therapy ulipristal acetate during the second half of 2017, on the back associated with positive data from a second pivotal Phase III Oughout. S. trial. The selective progesterone receptor modulator (SPRM) is marketed by Gedeon Richter in Europe beneath the trade name Esmya ® and Canada under the trade name Fibristal™, but has however to be approved in the U. S.
The particular Venus II study involved 432 U. S. sufferers, randomized to receive either 5 mg or 10 magnesium of ulipristal or placebo. The trial met all its co-primary and secondary endpoints, including percentage associated with patients with absence of uterine bleeding and time to lack of uterine bleeding on treatment during treatment course 1. A significantly greater number of patients in both the 10-mg ulipristal group of patients (54. 8%) and the 5-mg ulipristal team (42. 0%) achieved absence of bleeding compared with the placebo group (0%). A significantly higher number of patients within the 10-mg ulipristal group (55. 4%) and in the 5-mg ulipristal group (34. 6%) achieved absence of bleeding inside 10 days after treatment initiation in treatment course a single, compared with those in the placebo group (0. 0%).
Positive data from the first Phase III Oughout. S. Venus I trial was reported in May 2016. “We are pleased with the favorable results of Venus II assisting the efficacy and safety profile of ulipristal acetate as shown in our Venus I trial, ” stated David Nicholson, chief R& D officer, Allergan. “We are confident that the results of our Phase III studies for ulipristal acetate may potentially offer the first in support of oral treatment option for women suffering from uterine fibroids within the U. S. ”
Esmya and Fibristal are approved in their respective markets 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 firm buyout deals within the last few weeks. Earlier this month Allergan reported on a deal with Assembly Biosciences, through which it discussed rights to four of the latter’ s microbiome-founded stomach disease candidates. The firm in parallel announced the particular acquisition of an exclusive option to acquire Lysosomal Therapeutics, a Cambridge, MA-based developer of drugs for neurological disorders, which includes Parkinson’ s disease. Within the last month Allergan confirmed the definitive agreement to acquire regenerative medicines firm LifeCell pertaining to $2. 9 million in cash. In November 2016 Allergan completed the acquisition of Chase Pharmaceuticals Corporation, the clinical-stage biopharmaceutical company focused on the development of improved treatments pertaining to neurodegenerative disorders