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HRA Pharma Offloads Commercial Rights To Uterine Fibroid Therapy In U.S. And Canada

This article was originally published in The Pink Sheet Daily

Executive Summary

Specialty pharma PregLem gains rights to develop and sell ulipristal acetate for benign gynecological disorders in U.S. and Canada.

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PregLem Weighs Financing Options Well Ahead Of Uterine Fibroid Drug Launch

Esmya, an oral therapy being developed for symptomatic uterine fibroids, showed non-inferiority to GnRH agonists in a Phase III study.

PregLem Weighs Financing Options Well Ahead Of Uterine Fibroid Drug Launch

Esmya, an oral therapy being developed for symptomatic uterine fibroids, showed non-inferiority to GnRH agonists in a Phase III study.

Regulatory News, In Brief

Emergency contraceptive goes before advisory panel: Laboratoire HRA Pharma's emergency contraceptive ulipristal acetate gets a review from FDA's Reproductive Health Drugs Advisory Committee June 17. The company gained European Commission marketing authorization for the drug under the brand name EllaOne on May 15, 2009 (1"The Pink Sheet" DAILY, May 26, 2009). It can be used up to five days after unprotected sex, longer than Teva Pharmaceuticals' Plan B (levonorgestrel). Earlier this year, HRA Pharma agreed to sell Geneva-based PregLem rights to commercialize the same active ingredient to treat uterine fibroids and other benign reproductive disorders in the U.S. and Canada (2"The Pink Sheet" DAILY, April 15, 2010)

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