Healthcare Industry News: LibiGel
News Release - November 8, 2006
BioSante Pharmaceuticals Signs Bio-E-Gel(R) Marketing Agreement With Bradley Pharmaceuticals, Inc.Payments Could Exceed $40 Million Plus Royalties
LINCOLNSHIRE, Ill.--(HSMN NewsFeed)--BioSante Pharmaceuticals, Inc. (Amex:BPA ) today announced that it has signed an exclusive agreement with Bradley Pharmaceuticals, Inc. (NYSE:BDY ) for the marketing of Bio-E-Gel® (transdermal estradiol gel) in the United States. 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. In addition, Bradley has agreed to pay to BioSante royalties on sales of Bio-E-Gel, if and when Bio-E-Gel is approved by the U.S. Food and Drug Administration (FDA) and marketed by Bradley.
Bio-E-Gel is currently being reviewed by the FDA. BioSante submitted the Bio-E-Gel new drug application (NDA) in February 2006. Bradley, through its Kenwood Therapeutics division, has agreed to market Bio-E-Gel and target estrogen prescribing physicians in the U.S. comprised mostly of gynecologists with at least 49 Kenwood sales representatives. The total amount of the up-front and milestone payments mentioned above is net of BioSante's obligations to Antares Pharma, BioSante's licensor of the transdermal estradiol gel formulation in Bio-E-Gel.
"We are excited to have met another milestone toward our planned commercial launch of Bio-E-Gel," said Stephen M. Simes, president & CEO of BioSante. "We believe Bradley is an excellent mid-sized specialty pharmaceutical company to market Bio-E-Gel and that Bradley is in an excellent position to capture a share of the U.S. estrogen therapy market, which is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, is about $250 million. We look forward to working with Bradley toward a successful launch of Bio-E-Gel in 2007."
Dan Glassman, president & CEO of Bradley said, "We are impressed with the clinical results of the Bio-E-Gel development program and we believe Bio-E-Gel and its low dose regimen will be an attractive alternative for physicians who treat and for women who suffer from menopausal symptoms."
Bio-E-Gel is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women. Bio-E-Gel 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. Bio-E-Gel 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 designed 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. The women in the study were randomly assigned to one of four treatment arms: low-dose (0.87 g), mid-dose (1.7 g) or high-dose (2.6 g) of Bio-E-Gel, or matching placebo. The U.S. Food & Drug Administration (FDA) defined endpoints were a significant decrease over placebo in both the number and severity of hot flashes at week 4 and week 12 of treatment.
Study results showed a clear dose response in the reduction in the number and severity of hot flashes in the low, mid, and high doses tested. The most effective Bio-E-Gel dose decreased the number of hot flashes by 85 percent by 12 weeks of treatment, from 12.9 hot flashes per day at baseline to 1.6 per day at the end of the 3 month study. The decrease compared to placebo treatment was significant (p less than 0.0001), with a mean decrease of 11.3 hot flashes per day with Bio-E-Gel and a decrease of 6.1 per day with placebo by study end.
The lowest dose of Bio-E-Gel 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 Bio-E-Gel 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 lowest dose group completed the Phase III study.
Importantly, more than 80 percent of women who used Bio-E-Gel reported "great" or "moderate" results, a highly significant improvement over placebo treatment (p less than 0.0001). In its new drug application (NDA), BioSante is seeking approval for all three doses of Bio-E-Gel.
According to 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 NDA for Bio-E-Gel currently is undergoing FDA review and includes data from the pivotal Phase III clinical trial of Bio-E-Gel and data from three additional clinical trials; a transfer study, a sunscreen study and a pharmacokinetic study.
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.
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 168 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 Bio-E-Gel® (transdermal estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel new drug application (NDA) was submitted to the FDA in the first quarter 2006. 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 Inc. 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 Bio-E-Gel may not be approved by the FDA or that Bio-E-Gel 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.
Source: BioSante Pharmaceuticals
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