Azur Pharma Limited (Azur) has entered into a definitive agreement with BioSante Pharmaceuticals, Inc (BioSante) to acquire US rights to Elestrin. Elestrin is a fast drying gel formulation of estradiol which is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. Elestrin was approved by the US Food and Drug Administration (FDA) in December 2006 and is patented through June 2022.

Under the terms of the agreement, Azur paid BioSante $3.3 million comprised of a product licensing fee and payment for the transfer of the trademark and inventories, amongst other items. In addition, Azur Pharma will pay BioSante royalties and contingent milestones based on future net sales of Elestrin.

Azur will market Elestrin to estrogen prescribing physicians in the US, comprised mostly of gynaecologists, through its women's health and urology sales force. Seamus Mulligan, chairman and CEO of Azur, commented, "We are impressed with the potential for Elestrin in the United States given its approved ultra-low dose regimen. The product is an important addition to our women's health product portfolio and we look forward to launching our Elestrin efforts in early 2009."

"We are excited to sign this agreement with Azur," said Stephen M Simes, president and CEO of BioSante. "We believe Azur has excellent, established relationships with the leading US gynaecological practitioners who write the majority of estrogen prescriptions. We also believe Azur is in an excellent position to capture an important share of the US estrogen therapy market, which is currently estimated at approximately $1.4 billion in annual sales, of which the transdermal segment, mostly patches, is about $260 million. We look forward to working with Azur on the successful marketing of Elestrin."

Elestrin is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women. Elestrin is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner.

Azur is a privately held pharmaceutical company dedicated to enhancing patients' lives by developing and marketing pharmaceutical products in specialist therapeutic areas.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism.