Biotech Values

[DewDiligence]

BPAX was +52% intraday Thursday on the reporting of astonishingly
good safety data for LibiGel, a topical formulation of testosterone to
increase libido in women. However, the share price plummeted a few
hours later on the announcement of dilutive financing by Rodman &
Renshaw, closing +16% for the day.

After 850 patient-years in the phase-3 safety study, there were zero
deaths and only five CV events! (Since these are blinded data and half
of the patients in the trial are in the placebo arm, the effective number
of LibiGel patient-years to date is about 425.) This is 25-30% of the
total number of patient-years to be accrued in this trial by the time
the trial ends; however, the NDA filing, planned for 2011, need not
wait for all of the data from the safety study to mature.

http://finance.yahoo.com/news/BioSante-Pharmaceuticals-bw-965683156.html?x=0&.v=1

›BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in Phase III Program

Thursday August 13, 2009, 8:00 am EDT

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX ), today announced positive safety data in its ongoing LibiGel Phase III clinical development program.

BioSante reported that with over 1,250 women enrolled and almost 825 women-years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events. This analysis of blinded data indicates a very low cardiovascular event rate has occurred thus far. Therefore, in view of the excellent LibiGel safety profile, BioSante’s LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.

“The cardiovascular safety data indicate that LibiGel, to date, has been shown to be safe,” said Stephen M. Simes, BioSante’s president and CEO. “We are happy to see that LibiGel continues to show its safety in healthy women, and also in those women with at least two cardiac risk factors enrolled in our cardiovascular and breast cancer safety study. We will continue to analyze blinded cardiac event data on a regular basis. LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need also referred to as female sexual dysfunction (FSD).”

The Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that will enroll between 2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months. An NDA can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.

The LibiGel safety study is tracking a predefined list of cardiovascular events, in agreement with the FDA, including cardiovascular death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two cardiovascular risk factors including 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 over the course of the study.

In addition to the Phase III cardiovascular and breast cancer safety study, BioSante is conducting two LibiGel Phase III efficacy trials. The Phase III efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement).

As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

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. The gel formulation used in LibiGel is licensed from Antares Pharma, Inc. 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 aesthetic medicine (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery. Additional information is available online at: www.biosantepharma.com.‹