BioSante Announces Launch of Elestrin™ in the U.S.
LINCOLNSHIRE, Illinois (April 14, 2009) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the initiation of sales and marketing activity of Elestrin (estradiol gel) by Azur Pharma, BioSante’s licensee in the U.S. Azur licensed rights to Elestrin from BioSante in December 2008. Elestrin was approved by the U.S. FDA (Food and Drug Administration) in December 2006 and is patented through June 2022.
“We are excited to announce Azur’s launch of Elestrin,” 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.”
Azur will market Elestrin to estrogen prescribing physicians, comprised mostly of gynecologists. Azur recently increased its Women’s Health and Urology sales force to 65 people to support the launch of Elestrin. Mr. Seamus Mulligan, chairman and CEO of Azur, commented, “We are excited with the potential for Elestrin in the United States given its low dose regimen and proven effectiveness. The product is an important addition to our women’s health product portfolio.”
BioSante is entitled to receive Elestrin milestone 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.
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 3 months of therapy in a single prescription.
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)
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 LibiGelŪ (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. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II 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. Under BioSante’s license agreement with Antares Pharma, BioSante is required to pay Antares a portion of the royalties, license and milestone payments received for products covered by that agreement. 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.
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. 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 report 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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Harris D. McKinney, Inc.