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news.HRA Pharma and Watson Pharmaceuticals have signed a licensing agreement for the commercialisation of HRA Pharma's emergency contraceptive Ulipristal acetate in Canada.
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Ulipristal acetate, a new oral emergency contraceptive designed and developed by HRA Pharma, has received approval from the European Commission and the Food and Drug Administration in May 2009 and August 2010, respectively, as safe and effective in preventing unintended pregnancy for up to 120 hours, or five days, post-unprotected intercourse or contraceptive failure.
Marketed since October 2009 in Europe under the brand name ellaOne, Watson plans to launch the product in the US market as ella in the fourth quarter of 2010.
HRA Pharma plans to file a new drug submission for Ulipristal acetate with Health Canada before the end of 2010 and if approved, Watson is expected to be responsible for marketing and commercialisation of the drug in Canada.
HRA Pharma CEO Erin Gainer said that they were excited to expand their partnership with Watson for Ulipristal acetate into Canada.
Watson Global Brands executive vice president Fred Wilkinson said that as Watson continues to prepare for the fourth quarter 2010 launch of the ella (Ulipristal acetate) emergency contraceptive in the US, they were pleased that if approved in Canada, Watson will be responsible for bringing this emergency contraceptive to women across North America.