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BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced product development highlights and financial results for the year ended December 31, 2006.
"The last year has been a pivotal and transitional time for BioSante," said Stephen M. Simes, BioSante's president and chief executive officer. "We achieved a number of significant milestones with both our hormone therapy products and CaP nanotechnology. Most notably, for our Elestrin™ transdermal estradiol gel product, we filed a new drug application (NDA) in February 2006. We subsequently received U.S. Food and Drug Administration (FDA) approval of Elestrin in December 2006 for the lowest estradiol dose ever approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) in menopausal women. Just prior to the FDA approval, we signed, in November 2006, an agreement with Bradley Pharmaceuticals, Inc. (NYSE:BDY) for the marketing of Elestrin in the U.S.
"We are proud to have achieved an approval from the FDA, especially for a product that will help menopausal women, and for doses that comply with the recommendations of the FDA, the American College of Obstetricians and Gynecologists (ACOG) and other authoritative groups including the North American Menopause Society (NAMS), that the lowest effective dose of estrogen be used to treat menopausal women. Equally important, the lowest dose of Elestrin is significantly lower than the next lowest dose of estradiol currently approved and on the market for the treatment of hot flashes.
"We also are very pleased to have begun the Phase III clinical program for our transdermal testosterone gel, LibiGel® as a therapy for female sexual dysfunction. Based on FDA guidance to us, we believe that two Phase III safety and efficacy trials and one year of LibiGel exposure in a separate safety trial are the essential requirements for submission and, if successful, approval of an NDA.
"Our CaP nanotechnology continues to generate interest from the medical, business and government communities, in areas such as drug delivery and vaccines. In the last year, we made significant progress in our internal H5N1 program and received government grant money to help fund our other CaP work. We look forward to a successful and productive 2007, both with CaP and our transdermal hormone therapies, and a successful launch of Elestrin by Bradley mid-year," concluded Simes.
Product Development Highlights
Hormone Therapy Achievements
* In February 2006, BioSante submitted an NDA for Elestrin.
* In November 2006, BioSante signed an agreement with Bradley Pharmaceuticals, Inc. for the marketing of Elestrin (estradiol gel) in the U.S., through its Kenwood Therapeutics division. Under the terms of the agreement, BioSante received or will shortly receive already triggered milestone payments in the amount of $10.5 million. It is our understanding that Bradley expects to launch Elestrin in mid-2007 into the $1.3 billion estrogen therapy market with at least 50 sales representatives. BioSante has the right under the agreement to receive up to an additional $30 million upon the achievement of certain sales-based milestones plus royalties upon sales of the product.
* 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 and BioSante received three years of marketing exclusivity for Elestrin. Elestrin 12.5 micrograms per day is the lowest dose of estradiol approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms, and is, in fact, 50% lower than the next lowest dose currently approved and marketed for the treatment of hot flashes. BioSante also received notice of allowance for a new patent that covers the formulation used in Elestrin which once issued will expire on June 23, 2021. BioSante personnel are named inventors on the new patent.
* Results of the pivotal Phase III study of the safety and efficacy of Elestrin in the treatment of menopausal symptoms have been published in the March 2007 issue of Obstetrics & Gynecology, the primary journal of ACOG. The paper titled "Low Dose of Transdermal Estradiol (E2) Gel for Treatment of Symptomatic Postmenopausal Women," reports on BioSante's 12-week, double-blind, placebo-controlled Phase III study of 484 symptomatic menopausal women, which was designed to identify the lowest safe and effective dose of transdermal estradiol therapy. The lead investigator for the multicenter study was Dr. James A. Simon, Director of the Women's Health Research Center in Washington, D.C.
* Recent publications have reported on the potential health benefits of estrogen in menopausal women including the most recent issue of Circulation that reports on a French study which indicates the potential benefit of transdermal estrogen compared with oral estrogen.
* BioSante has initiated the Phase III development program for LibiGel in the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder. BioSante believes that two Phase III clinical studies will be required as well as an additional safety study to look specifically at the potential for cardiovascular risk of testosterone therapy. BioSante also believes that based on FDA guidance to BioSante that it may submit an NDA after six months of efficacy data and one year of testosterone safety exposure. Based on successful completion of the Phase III safety and efficacy trials and if the safety study does not show an unacceptable increase in cardiovascular risk, our LibiGel NDA may be approved. The Phase III trials will enroll approximately 360 subjects each. BioSante still is determining the number of subjects required for the safety trial, however, BioSante believes the number will be reasonable and affordable.
CaP Nanotechnology Achievements
* BioSante signed an option and license agreement with Medical Aesthetics Technology Corporation (MATC) for the development and commercialization of products in the field of aesthetic medicine, specifically, the improvement and/or maintenance of the external appearance of the head, face, neck and body. Under the amended agreement, MATC has until July 2007 to exercise its option to secure a license upon payment to BioSante of a license fee. Under the terms of the agreement, BioSante has the right to receive additional milestone payments upon approval by the FDA or first commercial sale of each product containing CaP, a royalty on net sales of any such products, and a share of any milestones and license fees from third party sublicenses.
* BioSante completed several animal studies using CaP as a vaccine adjuvant in the development of an H5N1 (Bird Flu) vaccine. Based on these results BioSante believes that CaP may be in a position to enhance the efficacy of H5N1 vaccines in development, allowing the use of significantly less vaccine and possibly allow for use via intranasal delivery instead of by injection.
* BioSante continued work under its subcontract with the University of Nebraska for the development of recombinant Factor IX formulations using CaP for delivery of Factor IX via alternative routes of administration for the treatment of hemophilia.
* BioSante completed its subcontract with Dynport Vaccine Company for the development of a second generation anthrax vaccine. BioSante currently is evaluating continued development or partnering to move this vaccine further in the pipeline.
Financial Results for 2006
For the year ended December 31, 2006, BioSante recorded net income of approximately $2.8 million or $0.13 per basic and diluted share for the year ended December 31, 2006, compared to a net loss of $9.7 million or ($0.50) per basic and diluted share for the same period in 2005. The company's cash, cash equivalents and short-term investments as of December 31, 2006 were approximately $11.5 million, compared to $9.1 million at December 31, 2005.
"2006 was a very important financial year for BioSante," said Simes. "We recorded our first ever year with net income which was primarily the result of the revenue from our agreement with Bradley for Elestrin. Due to a $2.625 million upfront licensing payment from Bradley and a $7.6 million private placement completed in July 2006, we were able to increase our cash balance from a year earlier. Based on our current cash balance and the additional milestone payments already due from Bradley, we believe we are in a solid financial position to move forward with our LibiGel development program and our other operations."
About BioSante Pharmaceuticals
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 LibiGel® (transdermal testosterone gel) in Phase III development 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 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 http://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, 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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BioSante Pharmaceuticals, Inc.
Phillip Donenberg, 847-478-0500
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