HRA Pharma (http://www.hra-pharma.com), a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology, announced today that ellaOne(R) (ulipristal acetate, 30mg), its new generation emergency contraceptive, has been launched in France, Germany and the United Kingdom via local HRA teams. HRA Pharma will progressively launch ellaOne in all European countries over the coming months.
ellaOne(R) is the first representative of a new therapeutic class, selective progesterone receptor modulators, and is the first molecule to have been specifically designed and developed for use as an oral emergency contraceptive. Clinical trials performed on more than 4000 women have shown that a single dose of ellaOne significantly reduces the number of pregnancies versus the number of expected pregnancies in absence of emergency contraception. ellaOne is different from currently used levonorgestrel-based emergency contraceptives, in that it maintains efficacy for 5 days after unprotected intercourse while its safety and tolerability profile has been demonstrated to be comparable to that of levonorgestrel.
"Our company is committed to advancing the discovery and development of new medicines tackling unmet needs in the field of reproductive health," said Erin Gainer, CEO of HRA Pharma. "The European launch of ellaOne is the result of more than 10 years of research and development and represents an important milestone, as it is the first licensed product to have been specifically designed and developed for use as an oral emergency contraceptive."
Since pioneering the launch of levonorgestrel for emergency contraception in 1999, HRA Pharma has been a leader in emergency contraception, providing solutions to unmet needs for millions of women in over 50 countries. The European launch of ellaOne is the first step in the international commercialisation of this product. The company plans to file for marketing approvals in countries worldwide under the trademarks ellaOne and ella, and continues to develop innovative projects in the field of reproductive health.