BioSante to distribute, market menopause treatment in the United States

LINCOLNSHIRE, Ill. BioSante Pharmaceuticals announced the initiation of sales and marketing activity of Elestrin (estradiol gel) by Azur Pharma, BioSante’s licensee in the United States.

Azur licensed rights to Elestrin from BioSante in December 2008. Elestrin was approved by the U.S. Food and Drug Administration in December 2006 and is patented through June 2022.

Elestrin (estradiol gel 0.06%) is a clean, clear, fast-drying estrogen formulation for the treatment of vasomotor symptoms associated with menopause. It is supplied in a dose-metered pump with the flexibility of delivering either a one-pump or a two-pump dose. The one-pump dose systemically delivers one of the lowest effective doses of estrogen approved by the FDA. The formulation is applied once daily over a small area of the upper arm, and provides up to three months of therapy in a single prescription.

 “We are excited to announce Azur’s launch of Elestrin,” said Stephen Simes, president and CEO of BioSante. “We believe Azur has excellent, established relationships with the leading U.S. gynecological practitioners who write the majority of estrogen prescriptions. We also believe Azur is in an excellent position to capture an important share of the U.S. estrogen therapy market, which is currently estimated at approximately $1.4 billion in annual sales.”