Public HealthHRA Pharma Granted European Marketing Authorization For EllaOne(R) - Next Generation Emergency Contraceptive
HRA Pharma, 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), its next generation emergency contraceptive,
has been granted marketing authorization by the European Commission. The
unanimous decision by all member states enables HRA Pharma to begin marketing
ellaOne throughout the European Union, making it the only approved product to
have been specifically designed and developed for use as an emergency
contraceptive.
"This milestone is testimony to emergency contraception as a
real therapeutic need and to the potential of ulipristal acetate as a viable
solution," said Dr. Erin Gainer, CEO of HRA Pharma. "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."
The European Commission"s marketing authorization follows the
positive opinion issued by the Committee for Medicinal Products for Human Use
of the European Medicines Agency in March 2009. ellaOne will be progressively
launched and marketed throughout the entire European Union, directly by HRA
Pharma in the UK, Germany, Italy and France and via partner companies
elsewhere.
Current hormonal emergency contraception (based on
levonorgestrel) is very well tolerated, but its efficacy decreases
significantly as time elapses after unprotected intercourse. Based on the new
chemical entity ulipristal acetate, ellaOne has been shown to have sustained
efficacy and has thus been approved for use up to five days after unprotected
intercourse, without compromising the safety or tolerability profile of
levonorgestrel.
HRA Pharma has long been a leader in emergency contraception,
providing solutions to unmet needs for millions of women in over 50 countries
since the launch of its pioneering product NorLevo. The company plans to file
for marketing approvals in countries worldwide under the trademarks ellaOne
and ella, and continues to research pharmaceutical developments in the field
of reproductive health that are better adapted to women"s lifestyles. HRA
Pharma is currently developing its compound ulipristal acetate for other
indications outside of emergency contraception, including uterine fibroids.
HRA Pharma