BioSante Pharmaceuticals Receives Milestone Payment from Bradley Pharmaceuticals
$7.0 million payment received under licensing agreement
LINCOLNSHIRE, Illinois (March 26, 2007) – BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced receipt of a $7.0 million milestone payment under the terms of its Elestrin™ (estradiol gel) licensing agreement with Bradley Pharmaceuticals, Inc. (NYSE: BDY). The payment is the first of two triggered by the December 2006 FDA approval of Elestrin. BioSante is entitled to receive an additional payment for this milestone in the amount of $3.5 million in December 2007. The net amount of the current milestone received by BioSante after payment to its licensor was $5.25 million. The net amount to BioSante of the December 2007 payment will be $2.625 million.
BioSante received approval from the FDA for the marketing of Elestrin in the United States on December 15, 2006. The FDA approved two doses of Elestrin, 12.5 micrograms per day and 37.5 micrograms per day in a non-conditional full approval. Elestrin 12.5 micrograms per day is the lowest dose of estradiol approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms, and is 50% lower than the next lowest dose currently approved and marketed for the treatment of hot flashes.
In November 2006, BioSante signed an agreement with Bradley Pharmaceuticals, Inc. for the marketing of Elestrin in the United States, through Bradley’s Kenwood Therapeutics division. Under the terms of the agreement, BioSante received an initial net payment of $2.625 million in 2006 based on a total licensing payment of $3.5 million. Bradley expects to launch Elestrin in mid-2007 into the $1.3 billion estrogen therapy market with a sales force of at least 50 sales representatives. BioSante has the right under the agreement to receive up to an additional $40 million ($30 million net after payments to its licensor) upon the achievement of certain sales-based milestones plus royalties upon sales of the product.
“We are pleased with the progress Bradley is making toward the marketing of Elestrin. We look forward to a mid-year 2007 launch,” said Stephen M. Simes, BioSante’s president and chief executive officer. “With about $15.0 million in cash, we are actively working on our recently begun LibiGel Phase III development program,” Simes continued.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bio-identical estradiol and testosterone. BioSante’s lead products include Elestrin™ (estradiol gel), developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGel® (transdermal testosterone gel) in Phase III development for the treatment of female sexual dysfunction (FSD).
The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women’s gel products are licensed by BioSante from Antares Pharma. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration. Additional information is available online at: biosantepharma.cdmail.biz.
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 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 and that transdermal estrogen may be safer than oral estrogen. The North American Menopause Society, the American College of Obstetricians and Gynecologists and the FDA all recommend women use the lowest effective dose of estrogen for the shortest period of time.
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 “may,” “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,” “believes,” “plans,” “hopes,” 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 cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, the success of clinical testing, obtaining regulatory and other approvals and achieving market acceptance, 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 Forms 10-K and 10-Q, which discussion also is 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.