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$3.5 million payment received under licensing agreement
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced receipt of a $3.5 million milestone payment under the terms of its Elestrin™ (estradiol gel) licensing agreement with Bradley Pharmaceuticals, Inc. (NYSE: BDY). The payment is the second of two triggered by the December 2006 U.S. Food and Drug Administration (FDA) approval of Elestrin and brings the total upfront and milestone payments received to $14.0 million. BioSante has the right under the agreement to receive up to an additional $40 million upon the achievement of certain sales-based milestones and has been receiving royalties since the mid-year launch of the product.
"We are pleased to receive this Elestrin milestone payment. We look forward to a full year of marketing in 2008 and expect that Elestrin sales will increase as prescribing physicians become more familiar with it," said Stephen M. Simes, BioSante's president and chief executive officer. "With about $30.0 million in cash, we actively are working on our LibiGel® (transdermal testosterone gel) Phase III development program," Simes continued.
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 a 50 percent lower dose of estradiol than the lowest dose patch for the treatment of moderate-to-severe vasomotor symptoms.
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 bioidentical estradiol and testosterone. BioSante's lead products include Elestrin™ (estradiol gel) developed through U.S. Food and Drug Administration (FDA) approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc., BioSante's licensee, and LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante for the treatment of female sexual dysfunction (FSD). 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 $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, drug delivery, and aesthetic medicine (BioLook™).
Elestrin is a fast-drying gel formulation of bio-identical estradiol, the same estrogen produced naturally in women. Elestrin was developed to be 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. The gel dries quickly in one to two minutes. Elestrin is administered using a metered dose applicator thereby allowing for precise titration from dose to dose.
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.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 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. Also, 25 percent of the upfront and milestone payments received from Bradley are paid to our licensor of the formulation in Elestrin. 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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for BioSante Pharmaceuticals, Inc.
Alan Zachary, McKinney/Chicago; (312) 944-6784 ext. 316
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