BioSante Pharmaceuticals, Inc. (BPA) Receives FDA Approval Of Bio-E-Gel(R) (estradiol gel), To Be Marketed As Elestrin(TM)
LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. today announced that it received U.S. Food and Drug Administration (FDA) approval for the marketing of Bio-E-Gel® (estradiol gel) in the United States. Bio-E-Gel, which will be marketed under the name Elestrin(TM), is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. Two doses of Elestrin(TM), 0.87 grams per day and 1.7 grams per day, were approved. Elestrin(TM) 0.87 grams per day is the lowest dose of estradiol approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms.
BioSante announced the signing of a marketing agreement with Bradley Pharmaceuticals, Inc. (NYSE:BDY - News) on November 8, 2006. Bradley plans to market Elestrin(TM) in the U.S. in 2007 through its Kenwood Therapeutics Division. Upon execution of the agreement, BioSante received $2.625 million. Additional regulatory and sales based milestone payments could bring the total of such payments from Bradley to BioSante to more than $40 million. The FDA approval of Elestrin(TM) has triggered a $7.875 million payment to BioSante, $5.25 million of which will be paid to BioSante within 14 weeks of approval and $2.625 million of which will be paid to BioSante within one year of approval. In addition, Bradley has agreed to pay to BioSante royalties on sales of Elestrin(TM) as well as sales-based milestone payments, when marketed by Bradley. The total amount of the up-front and milestone payments mentioned above is net of BioSante's obligations to Antares Pharma, Inc., BioSante's licensor of the transdermal estradiol gel formulation in Elestrin(TM).
The Kenwood Therapeutics Division of Bradley has agreed to market Elestrin(TM) with at least 49 Kenwood sales representatives targeting estrogen prescribing physicians in the U.S. comprised mostly of gynecologists.
"With FDA approval, BioSante has reached another important milestone. We are proud to have developed Elestrin(TM) from a formulation to FDA approval, and we have no future post-approval clinical development commitments," said Stephen M. Simes, president & CEO of BioSante. "From a commercial viewpoint, we believe Bradley is an excellent mid-sized specialty pharmaceutical company and is in a great position to capture a share of the U.S. estrogen therapy market, which currently is estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, is about $250 million. We are very excited that the lowest dose of Elestrin(TM) has been approved. It is significantly lower than the next lowest dose of estradiol currently on the market. We look forward to working with Bradley toward a successful launch of Elestrin(TM) in 2007."
Daniel Glassman, President & CEO of Bradley said, "By offering the lowest effective dose of estrogen in an elegant, easy-to-use gel, Elestrin(TM) will provide physicians with an important treatment for women suffering from menopausal symptoms. Plans for the launch of Elestrin(TM) in 2007 are well under way."
About Elestrin(TM)
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. Elestrin is administered using a metered dose applicator that delivers 0.87 g of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes.
A 12-week, double-blind, placebo-controlled Phase III study of 484 symptomatic menopausal women was conducted to identify the lowest effective dose to allow estrogen treatment in the safest possible manner. The lead investigator for the multicenter study was Dr. James A. Simon, director of the Women's Health Research Center in Washington, D.C.
Study results showed a clear dose response in the reduction in the number and severity of hot flashes in the doses tested. The lowest dose of Elestrin studied produces very low estradiol blood levels and exhibits a safety profile similar to that observed in the placebo group. There were no significant differences in the safety profile of any dose of Elestrin compared to placebo other than predictable estrogen effects, such as breast tenderness. Further, the application site reactions were minimal and very infrequent, and no subjects discontinued the study due to application site reactions. Nearly all subjects, 97 percent, in the Elestrin 0.87 grams group completed the Phase III study.
Importantly, more than 80 percent of women who used Elestrin reported "great" or "moderate" results, a highly significant improvement over placebo treatment (p less than 0.0001).
According to North American Menopause Society (NAMS), more than two-thirds of North American women have hot flashes during menopause. At present, oral conjugated estrogen is the primary treatment for this menopausal symptom. The U.S. estrogen therapy market is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, is about $250 million.
The new drug application (NDA) for Elestrin included data from the pivotal Phase III clinical trial of Elestrin and data from three additional clinical trials; a transfer study, a sunscreen study and a pharmacokinetic study.
About Estrogens
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 Bradley Pharmaceuticals, Inc.
Bradley Pharmaceuticals, Inc. was founded in 1985 as a specialty pharmaceutical company and markets to niche physician specialties in the U.S. and 38 international markets. Bradley's success is based upon strategically expanding from an Acquire, Enhance and Grow to an In-License, Develop and Bring to Market business model: In-license phase II and phase III drugs with long-term intellectual property protection; Develop these products and submit completed clinical studies to the FDA for NDA approvals and commercialization; Bring to Market these patent-protected brands to fill unmet needs and leverage Bradley's marketing and sales expertise to increase shareholder value. Bradley Pharmaceuticals is comprised of Doak Dermatologics, specializing in therapies for dermatology and podiatry; Kenwood Therapeutics, providing gastroenterology, OB/GYN, respiratory and other internal medicine brands; and A. Aarons, which markets authorized generic versions of Doak and Kenwood therapies. In total, Bradley has 175 sales representatives of which 49 currently are in the Kenwood Therapeutics division.
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(TM) (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGel® (transdermal testosterone gel) 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 avian flu and biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. Additional information is available online at: www.biosantepharma.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 "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, 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. Additional risk factors include the risk that Elestrin may not be successfully marketed. 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.