Antares Pharma’ partner BioSante has said that the LibiGel Safety Study External Executive Committee has recommended continuation of the LibiGel phase-III clinical program.
The decision of the committee was based upon review of phase-III Cardiovascular and Breast Cancer Safety Study for LibiGel. The data demonstrated a very low cardiovascular event rate in the LibiGel phase-III clinical studies.
The Executive Committee evaluated study information from over 1,000 women enrolled, totaling approximately 600 women-years of exposure in the LibiGel safety study. All serious adverse events including those in the cardiovascular categories as well as non-serious adverse events have been reviewed by the committee.
Paul Wotton, President and CEO of Antares, said: “We are very pleased to see further and encouraging progress made with LibiGel, which uses the Antares Pharma ATD system, an FDA approved technology. A transdermal gel offers an ideal means to deliver drugs like testosterone in a controlled and reproducible way with a convenient to use dosage form. We have an advanced and deep pipeline of ATD based products, including LibiGel, where we have significant intellectual property and commercialization rights. We expect to earn additional milestone and royalty payments in the future from our multi-product agreement with BioSante.”