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Azur Pharma Ltd. Enters Into Definitive Agreement With BioSante Pharmaceuticals Inc [nasdaq: BPAX], to Acquire U.S. Rights to Elestrin (TM)

DUBLIN, December 4 /PRNewswire/ -- Azur Pharma Limited ("Azur") today announced that it has entered into a definitive agreement with BioSante Pharmaceuticals, Inc ("BioSante")(Nasdaq: BPAX) to acquire U.S. rights to Elestrin(TM). 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 U.S. Food and Drug Administration ("FDA") in December 2006 and is patented through June 2022.

Under the terms of the agreement, Azur paid BioSante US$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 U.S., comprised mostly of gynecologists, through its women's health and urology sales force. Mr. 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 Mr. Stephen M. 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. Azur is in an excellent position to capture an important share of the U.S. estrogen therapy market, which is currently estimated at approximately US$1.4 billion in annual sales, of which the transdermal segment, mostly patches, is about US$260 million. We look forward to working with Azur on the successful marketing of Elestrin."

About Elestrin(TM)

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. Elestrin is administered using a metered dose applicator that delivers 12.5 micrograms of estradiol, one of the two lowest estradiol doses approved by the FDA for the treatment of hot flashes. The gel dries quickly in one to two minutes.

About Azur Pharma

Azur is a privately held pharmaceutical company dedicated to enhancing patients' lives by developing and marketing pharmaceutical products in specialist therapeutic areas. Azur's strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development and approved pharmaceutical products.


About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel(R) (transdermal testosterone gel) in Phase III clinical development by BioSante under a FDA Special Protocol Assessment for the treatment of female sexual dysfunction, and Elestrin(TM) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S.


SOURCE Azur Pharma Limited
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