Watson, Richter enter licensing agreement for Esmya

MORRISTOWN, N.J. — A subsidiary of Watson Pharmaceuticals has entered a licensing agreement with a subsidiary of Hungarian drug maker Richter to develop and market a drug for uterine fibroids, the two companies said Thursday.

Watson Labs and PregLem said European studies had shown Esmya (ulipristal acetate) to be a safe and effective treatment for the disease, a benign tumor condition that affects between one-fifth and one-fourth of women of reproductive age worldwide. Watson expected to start phase-3 studies of the drug in the United States in 2011.

Under the agreement, Watson will pay PregLem $17 million plus royalties based on U.S. and Canadian sales, as well as milestone payments. The companies also will collaborate on additional formulations of the drug, sharing development costs.

“Esmya represents a significant strategic addition to our portfolio of women’s health products and is potentially the first effective treatment for uterine fibroids in more than 20 years,” Watson CEO Paul Bisaro said.