BioSante Pharmaceuticals Announces the Commercial Launch of Elestrin™
Elestrin launched by Bradley Pharmaceuticals
Lincolnshire, Illinois (June 13, 2007) – BioSante Pharmaceuticals, Inc. (AMEX: BPA) today announced the launch of Elestrin (estradiol gel 0.06%) by the Kenwood Therapeutics Division of Bradley Pharmaceuticals, Inc. (NYSE: BDY). Elestrin is an effective, ultra-low dose transdermal estrogen therapy that was approved by the U.S. Food and Drug Administration (FDA) in December 2006 for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.
There are approximately 14,000 OB/GYN physicians in the U.S. who account for the majority of prescriptions in the $1.3 billion U.S. estrogen therapy market. The transdermal estrogen market is about $300 million. In order to support the launch of Elestrin to the OB/GYN specialty market, Bradley will increase the size of its Kenwood sales force and expects Kenwood to have up to 60 representatives.
“The commercial launch of Elestrin is particularly satisfying,” said Stephen Simes, president and chief executive officer of BioSante. “To bring a drug through the development process, including clinical trials and FDA approval, and finally to market where it is available to women with a need for estrogen therapy is a major accomplishment for BioSante. It is an experience and success that creates a base on which to build with the additional products in our pipeline, especially LibiGel® (transdermal testosterone gel) in development for the treatment of female sexual dysfunction.”
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 expected to be commercially launched shortly by Bradley Pharmaceuticals, Inc. in the U.S., and LibiGel® (transdermal testosterone gel) in Phase III development by BioSante for the treatment of female sexual dysfunction (FSD). Also in development is Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive 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, 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.
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.