HRA Pharma, a privately-held, European pharmaceutical company that develops healthcare solutions in reproductive health and endocrinology and makes them available worldwide, and Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, announced that they have entered into a licensing agreement for the commercialization of HRA Pharma’s next generation emergency contraceptive ulipristal acetate in Canada.
This agreement marks the next step for the commercialization of ulipristal acetate in North America and the second collaboration between the two companies in the field of reproductive health. Recently, the US Food and Drug Administration (FDA) approved ulipristal acetate, which Watson will market in the US under the name ella, as a prescription-only emergency contraceptive. HRA Pharma plans to file a New Drug Submission for ulipristal acetate with Health Canada before the end of 2010. If approved, Watson will be responsible for marketing and commercialization of ulipristal acetate in Canada.
“HRA Pharma strives to improve reproductive health with products and services that are accessible to women worldwide, and Watson continues to share this mission with us,” said Dr Erin Gainer, CEO, HRA Pharma. “We are excited to expand our partnership with Watson for ulipristal acetate into Canada. Our two companies share the commitment to making emergency contraception with ulipristal acetate available to women across North America.”
“As Watson continues to prepare for the fourth quarter 2010 launch of the ella (ulipristal acetate) emergency contraceptive in the US, we are pleased that if approved in Canada, Watson will be responsible for bringing this important emergency contraceptive to women across North America,” said Fred Wilkinson, executive vice president, Watson Global Brands. “We are committed to expanding our women’s health product franchise, and expanding our marketing presence globally with products that offer additional options and meet unmet medical needs. Extending our marketing relationship with HRA into Canada represents continued progress in achieving our vision for Watson as a leader in women’s health.”
Ulipristal acetate is a novel oral emergency contraceptive designed and developed by HRA Pharma. It was approved in May 2009 by the European Commission and in August 2010 by the FDA 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.