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news.Watson Pharmaceuticals and HRA Pharma have announced an exclusive licensing agreement for Watson to become the commercial partner for ulipristal acetate (UPA), a selective progesterone receptor modulator, in the US.
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UPA is a new emergency contraceptive developed by HRA Pharma specifically for emergency contraceptive use, that is approved and marketed by HRA Pharma in Europe as ellaOne since October 2009. UPA is at the New Drug Application (NDA) stage in the US.
According to the data recently published in the Lancet, which evaluated the efficacy of UPA as compared to levonorgestrel for emergency contraception among 1696 women in the UK, Ireland and the US, UPA provides effective, alternative emergency contraception for up to five days after unprotected sexual intercourse.
Under the terms of the licensing agreement, Watson will make payments to HRA Pharma, based on the achievement of certain milestones. In addition, Watson will also pay HRA Pharma a royalty on US sales of the product. Watson will be responsible for all US commercialization and marketing expenses.
Fred Wilkinson, executive vice president of global brands at Watson, said: “The opportunity to collaborate with HRA Pharma on the US commercialization of UPA fits nicely within our broader strategy to expand our emerging position in women’s health care and to provide women with a vast array of safe, effective treatment options in contraception as well as other important therapeutic areas.
“The published clinical results are significant, and we are optimistic about the prospects of providing US women with a new emergency contraceptive option.”
Erin Gainer, CEO of HRA Pharma, said: “We are excited to further our international expansion by partnering with Watson to bring UPA to the US.
“For over a decade, our mission has been to design custom-made solutions in women’s health that fill therapeutic gaps and improve overall patient health. Our first step into the US with Watson, who shares this same commitment to women’s health care, represents a crucial milestone for us in our vision of making UPA available to women worldwide.”