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Agreements

Date: 2011-05-19

Type of information: Licensing agreement

Compound: ellaOne® (ulipristal acetate)

Company: HRA Pharma (France) ASKA Pharmaceutical (Japan)

Therapeutic area: Gynecology - Women's health

Type agreement:

licensing
development
commercialisation

Action mechanism:

Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator that reversibly blocks the progesterone receptors in targeted tissues. 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 existing levonorgestrel-based methods.

Disease: emergency contraception

Details:

ASKA Pharmaceutical and HRA Pharma have announced the conclusion of exclusive licensing agreements for ASKA Pharmaceutical to develop and market ulipristal acetate in Japan in response to multiple women’s reproductive health issues, in particular emergency contraception.
Ulipristal acetate for emergency contraception, known as ellaOne® in Europe as well as ella® in the United States, has undergone an exhaustive program of trials in both the USA and Europe. HRA Pharma partnered with the American National Institute of Health first beginning its work to develop the emergency contraceptive pill nearly 12 years ago. Since that time it has undergone pre clinical and full clinical tests in over 4,000 women. The European Medicines Agency (EMA) approved ellaOne® in 2009 following its submission and the US regulatory authorities granted its license mid of last year. It is now available to women in the UK, France, Germany, and 23 other major European countries.

Financial terms:

Financial details of the agreement were not disclosed.

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Is general: Yes