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BPAX Sample Note to Clients on June 17, 2010

|Includes: ANI Pharmaceuticals, Inc. (ANIP)

Below is an excerpt of the client note sent out last week (before today's announcements).  For client reasons, we've redacted some text with XXXX (not proportional to length of text).


Biosante Pharmaceuticals (BPAX) is reporting further safety data next week from its LibiGel Safety Trial.  XXXX is expecting the safety trial to continue with a low rate of adverse events (AEs).

Safety Trial Background

The LibiGel Phase III Cardiovascular (NYSE:CV) and Breast Cancer (NYSE:BC) Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that expects to enroll between 2,400 and 3,100 women treated with either LibiGel (300 mcg testosterone daily) or placebo for 12 months.  Primary endpoints (1EP) include 1. Combined rate of adjudicated, predefined CV events and 2. Rate of breast cancer events.  XXXXXXXX.

CV events are defined as: CV death, nonfatal stroke, nonfatal myocardial infarction (NYSE:MI), hospitalized unstable angina, coronary revascularization, venous thrombo-embolic events.

The rate of breast cancers in the study are similar to the rate of breast cancers observed in the placebo arm of the 50-60 year old women in the WHI estrogen only arm (0.26% vs 0.33%, respectively).

Inclusion criteria in the safety study includes women age 50 or older, menopausal, positive diagnosis of HSDD and a presence of two or more of the following risk factors for cardiovascular disease (based on the RUTH Study, Barrett-Connor et al., 2006): age 60 to <70 years, age 70 or greater, diabetes mellitus, presently smoking, hypertension, dyslipidemia, ankle-brachial index <0.6, and a documented CV history.


October 2009: The Independent Data Monitoring Committee (IDMC) reviews all "serious adverse events" and all "adverse cardiovascular and breast cancer events" in 1,055 women with 883 women-years of exposure. There were no deaths, one myocardial infarction and three breast cancers reported. The IDMC unanimously recommended continuing the study.

February 2010: The IDMC again recommended continuing the study after reporting no deaths, seven adjudicated cardiovascular events and four breast cancers.

June 2010: Next IDMC review of approximately 1,500 women enrolled to-date.

Quick Facts - Clients Only

For more on BPAX, Libigel, or competitors, please contact Andrew Nava for information on retail and institutional rates and services.

Andrew Nava LLC provides institutional and retail healthcare investors with buy-side equity research tools that focus on value-driven investing, profitable trading ideas and clinical, commercial, and regulatory catalysts. Our research is supported by consulting with KOL's, industry professionals, company management, and powered by our database of clinical trial data and upcoming company milestones.

Disclosure: Long BPAX