European pharmaceutical company, HRA Pharma has announced that ellaOne has received authorization from the European Commission to market its new emergency contraceptive, ellaOne (ulipristal acetate). Touted as a next generation drug, ellaOne is the only emergency contraceptive to be specially designed as such. HRA Pharma specializes in designing devices, products, and services in the field of endocrinology and reproductive health. EllaOne is the first drug of its kind to have received marketing approval in Europe.
Dr. Erin Gainer, the CEO for HRA Pharma commented, “This milestone is testimony to emergency contraception as a real therapeutic need and to the potential of ulipristal acetate as a viable solution. Our goal is to ensure that ellaOne is available to the millions of women who might need it, and we plan to put our sales and marketing infrastructure as well as our privileged partnerships into action to accompany this roll-out.”
Marketing authorization by the European Commission is granted only after a positive review is issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Such a positive review was issued in March of 2009. Now that these hurdles have been cleared, it is expected that ellaOne will be given a strong launch and marketed throughout all of the European Union. In the UK, France, Italy, and Germany, HRA Pharma will be the direct marketer of the product, whereas in other geographic locations, partner companies will be in charge of ellaOne’s promotion in the health care market.
While the current emergency contraceptives have few side effects, these hormone-based medications lose their effectiveness as time marches on. Such contraceptives, meant for use after unprotected sex, are based on levonorgestrel. The new kid on the block, ellaOne, is based on the addition of a new chemical formulation, ulipristal acetate. Due to its special formula, ellaOne has been found to be effective and approved for use for up to five days after unprotected sex.
HRA Pharma has been a significant leader in providing emergency contraception and other solutions for women’s problems in some 50 countries since the launching of its other, earlier wonder drug, NorLevo. The company will be seeking approval in countries outside of the EU; marketing the new drug under the names ellaOne and ella. HRA Pharma also hopes to continue to make startling finds in the field of reproductive medicine that are well-suited to the modern woman’s lifestyle.