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Summary of BioSante Pharmaceuticals (BPAX)

|Includes: ANI Pharmaceuticals, Inc. (ANIP), TEVA

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BioSante Pharmaceuticals is traded on the Nasdaq Global Market under the stock ticker symbol BPAX. BioSante Pharmaceuticals is listed on the Russell 3000 Index, the Russell 2000 Index and the Russell Microcap Index. On June 30, 2010, BioSante has 70,802,894 common shares outstanding and approximately $46.4 million in cash and cash equivalents.

Oppenheimer and Co. Inc. rates BioSante as Outperform with a $6 price target. Rodman & Renshaw rates BioSante as Market Outperform with a $4 price target. Roth Capital Partners rates BioSante as Buy with a $4 price target.


BioSante’s lead near term product in development is LibiGel for the treatment of Hypoactive Sexual Desire Disorder (HSDD), a form of female sexual dysfunction (NYSE:FSD). Hypoactive Sexual Desire Disorder (HSDD) is defined as decreased sexual desire that leads to personal distress. After a woman goes through menopause or had a hysterectomy, the body reduces its production of testosterone, which can result in decreased desire. Testosterone is not just a male hormone. Testosterone actually plays an important role in a woman's sex drive. Low testosterone may contribute to the symptoms of decreased desire. Decreased desire or low libido may have a lot less to do with mood or other aspects of life and a lot more to do with hormone levels.

LibiGel is a testosterone gel in development by BioSante Pharmaceuticals. LibiGel is designed to be quickly absorbed through the skin delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. LibiGel is dosed once a day, on the upper arm, in a pea-size volume and provides a nominal daily delivery of 300 mcg testosterone. The topical application of LibiGel has the added advantage of reduced skin reactions compared to other forms of transdermal delivery systems.

To date no compound has been approved by the US FDA to treat female sexual dysfunction, specifically HSDD. Although there are currently no pharmaceutical products approved for the treatment of FSD in the US, over 4 million prescriptions for testosterone were written off-label by physicians in 2009.

LibiGel has the potential to safely improve female sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with HSDD. The LibiGel development program has been designed to show that LibiGel can safely improve female sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with HSDD. A completed LibiGel Phase 2 clinical trial has shown excellent results with a significant 238% increase in the total number of satisfying sexual events. The results of the Phase 2 trial showed no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel.


BioSante currently has underway two Phase 3 pivotal efficacy trials under a Special Protocol Assessment (NYSE:SPA) agreement with the FDA and one Phase 3 safety study based on an FDA approved protocol. A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that an uncompleted Phase 3 trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. The FDA SPA agreement of the pivotal Phase 3 efficacy trials include agreements on the study design, efficacy end points, sample size, study conduct and statistical analysis plan.

BioSante has underway two 500 women, Phase 3, randomized, double-blind, placebo-controlled trials of the safety and efficacy of LibiGel in the treatment of women with HSDD. These trials will measure the change from baseline in the number of satisfying sexual events and in sexual desire.

In addition, a Phase 3, randomized, double-blind, placebo-controlled, CV and breast safety study of LibiGel in menopausal women with HSDD is ongoing. The study will provide an average minimum exposure of 12 months of T therapy prior to a new drug application (NDA) to obtain marketing approval and then continue with a 48-month, placebo-controlled follow-up period.  Between 2,500 and 4,000 post-menopausal women with HSDD, 50-80 years of age, and at least two CV risk factors will be enrolled in the adaptive design safety study to receive LibiGel 300 mcg daily or an identical placebo gel.


In addition to the lead product candidate, LibiGel, BioSante has other product candidates. These other product candidates include a drug with FDA approval, a drug expecting NDA filing by the end of 2010 and multiple product candidates with FDA Orphan Drug designations.

Elestrin is an ultra low-dose, transdermal estradiol gel indicated for the treatment of moderate-to-severe hot flashes associated with menopause. Hot flashes (also known as night sweats) are a common symptom of menopause and perimenopause. Hot flashes are typically experienced as a feeling of intense heat with sweating and rapid heartbeat, and may typically last from two to thirty minutes for each occurrence. Elestrin provides significant reductions in both the frequency and severity of moderate-to-severe hot flashes and night sweats. Elestrin was approved by the FDA in 2006. Elestrin is marketed in the U.S. by Azur Pharma.

Bio-T-Gel is BioSante's drug currently under a license and development agreement with Teva Pharmaceuticals. Bio-T-Gel is a once-daily transdermal testosterone gel currently in development for the treatment of male hypogonadism, or low testosterone levels. Male hypogonadism generally is characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis. In 2009, the transdermal testosterone market in the U.S. was over $800 million. Bio-T-Gel is being developed and will be marketed by Teva Pharmaceuticals. Teva Pharmaceuticals is expected to submit an New Drug Application for Bio-T-Gel to the FDA by the end of 2010. In addition to receiving $1.5 million upfront, BioSante is eligible for certain milestone payments, along with royalties if and when the product is commercialized.

The Pill-Plus is an oral contraceptive currently in development. The Pill-Plus is a triple component formulation, which adds an androgen, similar to testosterone, to the typical contraceptive combination of estrogen and progestin. In 2007, BioSante signed an agreement with Pantarhei Bioscience for the development and marketing of an oral contraceptive in the United States. BioSante may receive certain development and regulatory milestones for the first product developed under the license. In addition, BioSante will receive royalty payments on sales of the product in the U.S. If the product is sublicensed by Pantarhei to another company BioSante will receive a percentage of any and all payments received by Pantarhei for the sublicense from a third party.

BioSante is developing BioLook as a facial line filler. Preclinical testing has shown that BioLook may act as a long-lasting injectable filler and has shown no adverse events. BioLook should be extremely user–friendly and may be applicable to improving both facial wrinkles and larger facial volume needs. BioLook is licensed to Medical Aesthetics Technology Corporation who plans to move into human clinical trials in 2010.

BioSante also is developing a vaccine adjuvant (BioVant) in vaccines such as H1N1, Hepatitis B and potentially cancer immunotherapies. 

Currently, several of BioSante’s cancer immunotherapies are in Phase II clinical trials at Johns Hopkins Cancer Center. BioSante has been granted FDA Orphan Drug designation for its pancreatic cancer, acute myeloid leukemia and chronic myeloid leukemia vaccines.

Disclosure: LONG BPAX