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Thursday, February 3, 2011

Biotech/Pharma Profile Update for BioSante Pharmaceuticals, Inc.

Key Highlight: BioSante Pharmaceuticals is Only Company in World In Phase III Clinical Development for Treatment of Female Sexual Dysfunction

Point Roberts, WA, LINCOLNSHIRE, Ill - February 3, 2011 Investorideas.com, a leader in sector research, updates the company profile for BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for investors following biotech and pharma stocks.
Recent News:
"BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Provide Update on LibiGel Safety Study at International Society for the Study of Women's Sexual Health Meeting"
LINCOLNSHIRE, Ill. - February 3, 2011 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that it will provide a LibiGel safety study update, and is supporting two clinical symposia at the Annual Meeting of The International Society for the Study of Women's Sexual Health Meeting (ISSWSH) being held from February 10-13, 2011 at the Doubletree Paradise Valley resort in Scottsdale, Arizona. More than 300 experts and practitioners in women's health and female sexual dysfunction (FSD) are expected to attend the meeting.
Read the full news release, click here .
Company Overview:
BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. www.biosantepharma.com
The BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
Read the full BPAX Investor Presentation at: http://www.investorideas.com/CO/BPAX/news/2011/BPAX-Presentation-012111.pdf
Financial Highlights
  • At December 31, 2010, BioSante had approximately $39M in cash
  • Monthly burn rate of approximately $3.5M - $4.0M
Trading Data
  • NASDAQ: BPAX
  • Recent Price (2/2/11): $1.93
  • Market Cap: $150M
  • Average Daily Volume: 1.1M
  • Common Shares Outstanding: 81.4M
  • 52-Week Range: $1.29-$2.50
  • Fiscal Year Ends: December 31
Investment Highlights
  • Financial resources to continue corporate strategy
  • Late stage pharmaceutical product portfolio with significant growth potential
  • LibiGel in three ongoing Phase III safety and efficacy clinical studies
  • Elestrin is FDA approved and marketed in the U.S.
  • Proprietary cancer vaccines in Phase II clinical trials
  • Focused growth strategy
  • Management's proven ability to gain FDA approval, implement plans and increase stockholder value
LibiGel Facts
Full LibiGel Brochure at: http://www.investorideas.com/CO/BPAX/news/2011/LibiGel-Brochure-Jan2011.pdf
LibiGel®* Treatment of Women with
Hypoactive Sexual Desire Disorder (HSDD)
LibiGel® is a gel formulation of testosterone in development that is quickly absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
Regulatory Status
The LibiGel clinical development program, in consultation and agreement with the FDA, has been designed to show that LibiGel can safely improve women's sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with HSDD. BioSante is conducting three Phase III LibiGel clinical studies and BioSante's objective is to submit a new drug application (NDA) to the FDA in 2011 for a potential approval in 2012.
Progress and Plans in Phase III:
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials that are underway are randomized, double blind, placebo-controlled trials which will enroll approximately 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study of between 2,750 and
4,000 women exposed to LibiGel or placebo. BioSante will follow the women enrolled in the safety study for a total of 5 years. However, after an average of 12 months' exposure BioSante intends to submit a LibiGel NDA for review and potential approval by FDA.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least two cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked throughout the study.
BioSante has reported that in the first 2,750 women enrolled comprising approximately 2,700 women-years of exposure, there have been only 14 adjudicated cardiovascular events even though the safety study is enrolling women with a higher risk of cardiovascular events. To date, over 2,750 women have been enrolled.
BioSante's obective is to submit the LibiGel NDA in 2011 for a potential FDA approval in 2012.
Contact BioSante Pharmaceuticals
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220; azachary@mckinneychicago.com
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
To the extent any statements made in this news release deal with information that is not hist orical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release 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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