BioSante Pharmaceuticals Signs Elestrin™ Marketing Agreement with Azur Pharma
Payments could reach $144.5 million plus royalties
LINCOLNSHIRE, Illinois (December 4, 2008) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has signed an exclusive agreement with Azur Pharma for the marketing of Elestrin(estradiol gel) to treat moderate-to-severe hot flashes in menopausal women in the United States. Upon execution of the agreement, BioSante received $3.325 million comprised of a $0.5 million product licensing fee and $2.825 million for transfer of the Elestrin trademark and inventories, among other items. BioSante also is entitled to receive additional payments of up to an aggregate of $144.5 million if certain sales-based milestones are achieved. In addition, Azur has agreed to pay to BioSante royalties on sales of Elestrin ranging from 10 percent to 20 percent depending on the annual sales level.
Azur has agreed to market Elestrin using its womenís health and urology sales force of approximately 50 sales people that targets estrogen prescribing physicians in the U.S. comprised mostly of gynecologists. In addition, Azur has agreed to minimum marketing expenditures in the first two years of the agreement.
“We are excited to sign this agreement with Azur,” said Stephen M. Simes, president & 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, of which the transdermal segment, mostly patches, is about $260 million. We look forward to working with Azur on the successful marketing of Elestrin.”
Seamus Mulligan, Chairman and CEO of Azur Pharma said, “We are impressed with the potential for Elestrin in the United States and we believe Elestrin and its approved ultra-low dose regimen will be an attractive alternative for physicians who treat and for women who suffer from menopausal symptoms.”
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 and 67 percent lower than the lowest dose estrogen patch approved by the FDA for the treatment of hot flashes. The gel dries quickly in one to two minutes.
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® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) 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.
Under BioSanteís license agreement with Antares Pharma, BioSante is required to pay Antares 25 percent of license and milestone payments received for products covered by that agreement in the U.S. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II/III clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™). Additional information is available online at biosantepharma.cdmail.biz.
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. (Website: www.azurpharma.com)
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as “will,” “potential”, “could,” “can,” “intends,” “continue,” “plans,” “expects” or comparable terminology, are forward-looking statements. Examples of forward-looking statements in this news release include statements regarding the expected timing of the initiation of clinical trials and the submission of regulatory applications. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements.
Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed in BioSante’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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