BioSante Pharmaceuticals Announces Issuance of New Patent Covering Elestrin™
LINCOLNSHIRE, Illinois (January 5, 2009) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that a new patent has issued covering Elestrin™ (estradiol gel), which is approved in the U.S. for moderate-to-severe vasomotor symptoms, known as hot flashes, associated with menopause. BioSante received approval of Elestrin from the U.S. Food and Drug Administration (FDA) in December 2006.
U.S. Patent 7,470,433 issued on December 30, 2008, and is expected to expire on June 25, 2022. The named inventors of this patent are from BioSante and Antares Pharma, BioSante’s licensor. The patent is assigned to Antares. This new patent is the second issued patent that covers Elestrin providing further protection against generic competition.
On December 4, 2008, BioSante announced that it signed an exclusive agreement with Azur Pharma for the marketing of Elestrin in the United States. Upon execution of the agreement, BioSante received $3.325 million. 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.
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. Two doses of Elestrin, 12.5 micrograms per day and 37.5 micrograms per day, were approved by the FDA and are marketed in the U.S. 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.
Estrogen products today are approved for the treatment of menopausal symptoms, including hot flashes. Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease, breast cancer or dementia. The Women’s Health Initiative (WHI) study reported increased risk of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with 0.625 mg of oral conjugated equine estrogens alone per day, relative to placebo.
The WHI study reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during five years of daily treatment with 0.625 mg of oral conjugated equine estrogens combined with 2.5 mg of medroxyprogesterone acetate per day. Although studies involving hormone use and breast cancer risk have produced varied results, newly reported estrogen-only data provide strong evidence that estrogen alone does not increase the risk of breast cancer, and in fact may decrease the risk. The North American Menopause Society (NAMS), the American College of Obstetricians and Gynecologists and the FDA all recommend women use the lowest effective dose of estradiol for the shortest period of time.
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.
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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