Atrix Laboratories Inc announced that Tecnofarma International Ltd, Atrix's Latin American licensee, received marketing authorisation from the Mexican regulatory authorities for the company's one and three-month prostate cancer products.
Eligard 7.5mg (leuprolide acetate for injectable suspension), a one-month prostate cancer product was launched in May. Eligard 7.5mg and 22.5mg are indicated for the palliative treatment of hormone sensitive advanced prostate cancer.
"We estimated the private market in Mexico to be approximately $4 million. However, regardless of the size of the market, it is our goal to make Eligard a global product and give access to this new treatment option for prostate cancer patients around the world," said Michael R. Duncan, Atrix's vice president and general manager.
Additionally, Tecnofarma has submitted for marketing authorisations in Peru, Venezuela, Bolivia, Chile and in other countries of the region. Tecnofarma currently markets Eligard in Argentina. The estimated total market for hormone therapies like Eligard is approximately $3.3 million.
In 2002, Tecnofarma entered into a supply agreement for Eligard in Latin America including Mexico. Atrix will manufacture the products in its Fort Collins, Colorado facility.
Eligard products, like other hormonal treatments for prostate cancer, cause a transient increase in serum concentrations of testosterone during the first week of treatment. Response to these products should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.