20100715_ellaone pr mkt

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Ulipristal acetate (ellaOne®) significantly reduces pregnancy risk
versus levonorgestrel for oral emergency contraception
European Medicines Agency confirms findings from HRA Pharma’s most recent data
Paris, France July 15, 2010 - HRA Pharma announced today that the European Medicines Agency (EMA) review
of the company’s most recent pivotal clinical efficacy has concluded that emergency contraception with
ulipristal acetate (ellaOne®) is significantly more effective than levonorgestrel in reducing pregnancy risk.
The EMA evaluated the complete results of a large Phase 3 pivotal comparative randomized trial vs.
levonorgestrel and a meta-analysis of two comparative studies vs. levonorgestrel including nearly 3 500
women. These data, published in The Lancet in February 2010, reported that ulipristal acetate, compared to
levonorgestrel, nearly halved the risk of pregnancy when taken within 72 hours (O.R. 0.58 [0.33; 0.99],
p=0.0462) of unprotected intercourse and reduced the risk by almost two thirds when taken within 24 hours
(O.R. 0.35, [0.11; 0.93], p=0.0346).
The validation by the EMA of these results comes just weeks after the FDA Advisory Committee for
Reproductive Health Drugs unanimously recommended approval of this drug for emergency contraception in
the US.
HRA Pharma is pleased with this outcome that officially recognizes ellaOne’s unique product profile as the most
effective alternative for oral emergency contraception. ellaOne is the first and only oral emergency
contraceptive indicated for 5 days and is as well tolerated as levonorgestrel.
ellaOne was approved in May 2009 by the European Commission for marketing as an emergency contraceptive
within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. The product was launched
in October 2009 and is marketed today in 22 European countries.
1. Glasier A, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-
inferiority trial and meta-analysis. Lancet 2010; 375: 555-562 2. Summary of Product Characteristics, approved in July 2010. About emergency contraception
Even in countries where highly effective methods are widely used, the rate of unintended pregnancies remains
high. Worldwide, some 80 million unintended pregnancies occur every year (38% of all pregnancies); in the US,
there are about 3 million unintended pregnancies each year (50% of all pregnancies); similar statistics are
reported in other countries (1,2,3).
Using emergency contraceptive pills in the first few days after unprotected intercourse or contraceptive failure
(missed pill, condom breakage) reduces the risk of getting pregnant, giving a woman a second chance to
prevent pregnancy if her birth control failed, or she had sex without using contraception. Making emergency
contraception available and informing women about it can help prevent unintended pregnancies.
1. The potential of long-acting reversible contraception to decrease unintended pregnancy. Speidel J. Joseph; Harper Cynthia C.; Shields Wayne C.; Contraception 78 (2008) 197–200 2. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Finer LB, Henshaw SK. Perspect Sex Reprod Health 2006;38:90–6. 3. The timing of the “fertile window” in the menstrual cycle: day specific estimates from a prospective study. Allen J Wilcox David Dunson, Donna Day Baird BMJ. 2000 November 18;321(7271): 1259–1262. About ulipristal acetate
Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator which reversibly
blocks the progesterone receptors in target tissues. Clinical trials performed on more than 4000 women have
shown that when taken within 5 days of unprotected intercourse, a single dose of 30mg of ulipristal acetate
significantly reduces the number of pregnancies versus the number of expected pregnancies in absence of
emergency contraception. The compound has been approved in May 2009 for marketing in the European
Union and to date has been launched under the trademark ellaOne® in 22 countries. In June 17, 2010, the US
FDA Advisory Committee for Reproductive Health Drugs unanimously recommended approval of this drug for
emergency contraception in the US. ellaOne® is an alternative choice to the currently widely-used
levonorgestrel-based emergency contraceptive, 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. As an innovative compound, ulipristal acetate has multiple applications for reproductive health
and is currently undergoing clinical trials for the treatment of uterine fibroids.

About HRA Pharma
HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and
supporting services in niche areas of health and makes them available to doctors and patients worldwide. A
pioneer in emergency contraception, the company targets therapeutic gaps in the areas of reproductive
health and endocrinology, and uses innovative marketing solutions and socially-conscious programs, such as
contraception education in developing countries, to promote healthy management of drugs and diseases.
Headquartered in Paris, France and with offices in Germany, Italy, Spain and the UK, HRA Pharma has built a
strong network of R&D, manufacturing, distribution and NGO partners which enables it to satisfy critical
patient needs and improve patient health in over 50 countries across the globe. Visit
www.hra-pharma.com for more information.

Source: http://www.hra-pharma.com/downloads/2010_07_15_ellaOne_PR_MKT.pdf


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