Healthcare Industry News: LibiGel
News Release - August 7, 2008
BioSante Pharmaceuticals Announces Reacquisition of Elestrin(TM), FDA Approved for Treatment of Hot FlashesLINCOLNSHIRE, Ill.--(HSMN NewsFeed)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX ) announced today that it has reacquired Elestrin (estradiol gel) from Nycomed US who in February 2008 acquired Bradley Pharmaceuticals, Inc., BioSante’s previous licensee of Elestrin. BioSante immediately will assume all manufacturing, distribution and marketing responsibilities for Elestrin. Elestrin is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women, and is U.S. Food and Drug Administration (FDA) approved for the treatment of hot flashes in menopausal women.
“We are pleased to reacquire Elestrin since Nycomed concentrates on dermatology products and neither Bradley nor Nycomed to date were successful in marketing Elestrin,” said Stephen M. Simes, BioSante’s president & CEO. “BioSante will pursue the best course of action to maximize the value of Elestrin. These considerations will become part of our formal strategic review being led by Deutsche Bank Securities Inc. who we recently engaged as our strategic advisor to assist us in our ongoing process to explore strategic alternatives in order to maximize value to our stockholders.”
In addition to Elestrin which BioSante developed through FDA approval in 2006, BioSante actively is developing LibiGel® (testosterone gel) for the treatment of female sexual dysfunction (FSD) in menopausal women, specifically hypoactive sexual desire disorder (HSDD). Today in the U.S. there is no FDA approved pharmaceutical product for either FSD or HSDD, a market estimated to be approximately $2.0-$4.0 billion in size. BioSante believes LibiGel, if approved by the FDA, may be the first pharmaceutical product approved in the U.S. for the treatment of HSDD in menopausal 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. Elestrin is administered using a metered dose applicator that delivers 12.5 micrograms of estradiol, a dose that is 67 percent lower than the lowest dose transdermal estradiol patch that is FDA approved for the treatment of hot flashes in the U.S.
Elestrin 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 12.5 microgram 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<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 total, single-entity U.S. estrogen therapy market is estimated at approximately $1.4 billion in annual sales, of which the transdermal segment, mostly patches, is about $260 million. 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. 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 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: 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 “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 market conditions applicable to strategic alternatives, the availability of strategic alternatives to BioSante, timely and successful implementation by BioSante of one or more strategic alternatives, whether such strategic alternatives will result in increasing stockholder value, BioSante’s eventual need for additional financing to implement its current business plan, 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.
Source: BioSante Pharmaceuticals
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