Biotech Values

[DewDiligence]

BioSante provides update on Bio-E-Gel:

[Although Bio-E-Gel is BPA’s most advanced product in terms of its development status, LibiGel (#msg-4116429) represents a larger component of BPA’s underlying value. That’s because there are manifold estrogen-replacement products on the market for menopausal women, but there are as yet no approved products for HSDD. Consequently, Bio-E-Gel might have sales potential of $50-100M, but LibiGel’s potential is very much larger. Note the important use of the word “one” in the bold-faced paragraph below.]

http://biz.yahoo.com/bw/041007/75416_1.html

>>
BioSante Pharmaceuticals Announces Update on Bio-E-Gel Phase III Clinical Trial and Presents Phase II Efficacy Results at NAMS Meeting

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Oct. 7, 2004--BioSante Pharmaceuticals, Inc. (AMEX:BPA) announced today an update regarding its ongoing pivotal Phase III clinical trial of Bio-E-Gel(TM) (bioidentical estradiol transdermal gel) for the treatment of moderate-to-severe hot flashes and vaginal atrophy in menopausal women. The Phase III trial is on track to enroll all subjects by year-end 2004, and is planned to be completed by the end of the first quarter 2005. A new drug application (NDA) will be filed as soon as possible after completion of the trial. In addition, BioSante will present Bio-E-Gel Phase II efficacy and pharmacokinetics data at the annual meeting of the North American Menopause Society in Washington, D.C. on October 8, 2004.

"The Bio-E-Gel Phase III clinical trial is testing three doses of Bio-E-Gel to maximize the safety profile by identifying the lowest effective dose," said Dr. Leah M. Lehman, BioSante's vice president of clinical and regulatory affairs. "Our objective is to establish the lowest effective dose of Bio-E-Gel and thereby determine the safest dose, avoiding the need for a Phase IV trial or label restriction. We observe strong subject interest in participating in our trials, which we believe is a reflection of the need for a more natural estrogen therapy that overcomes many of the undesirable effects of current estrogen therapies."

The Phase III trial followed the completion of a Phase II clinical trial designed to identify an effective dose of Bio-E-Gel to study in Phase III development. All doses of Bio-E-Gel studied in the Phase II trial showed significant decreases in the frequency and severity of hot flashes versus baseline (p<0.0001). By week four, one dose demonstrated a significant reduction in the frequency and severity of moderate-to-severe hot flashes versus placebo (p<0.05). At week four, this effective dose reduced hot flashes by 86 percent versus 53 percent in the placebo group. Of the 161 women in the Phase II trial, only four women experienced a brief episode of mild application site reaction, a side-effect known to be associated with patches. There were no clinically important adverse events observed during the trial.

"We are very pleased to be nearing completion of this Phase III study of Bio-E-Gel," said Stephen M. Simes, president and chief executive officer of BioSante. "This Phase III trial and the planned NDA are very important milestones for the company. We have been committed to moving our pipeline of hormone therapy products through clinical trials, and we now have reported very important positive results for both Bio-E-Gel for reduction of hot flashes and LibiGel(TM) in the treatment of female sexual dysfunction."

The ongoing Phase III trial being conducted in the United States and Canada is a randomized, 12-week, double-blind, placebo-controlled study of symptomatic menopausal women. Current FDA requirements for approval of new estradiol products include one 12-week Phase III clinical trial. [Note the importance of the word “one” –the FDA’s standard requirement for approval of an estrogen-replacement product is only a single phase-3 trial rather than the two phase-3 trials required in most medical indications.]

Bio-E-Gel is a gel formulation of estradiol (the bioidentical human estrogen) designed to be quickly absorbed through the skin after topical application on the arms, shoulders, thighs or abdomen, delivering estradiol to the blood-stream evenly over time at minimal dosage and in a non-invasive, painless manner. Estrogen products today are approved for the treatment of menopausal symptoms, including hot flashes and vaginal atrophy. Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease.

"We look forward to the completion of the Phase III trial and subsequent NDA submission," Simes said. "We believe Bio-E-Gel will be well positioned to compete in the U.S. hormone therapy market, currently estimated to total approximately $2.5 billion in annual sales."

BioSante's hormone therapy portfolio

In addition to Bio-E-Gel, BioSante is developing LibiGel(TM) bioidentical testosterone gel for treatment of female sexual dysfunction and Bio-T-Gel(TM) bioidentical testosterone gel for treatment of men with testosterone deficiency. Additionally, a combination hormone therapy gel product containing estradiol and progestin is being developed under a license with Solvay Pharmaceuticals, B.V, and an unnamed BioSante hormone therapy product is being developed by Teva Pharmaceuticals USA, Inc. under a license agreement. The transdermal gel formulations used in the female gel products are licensed by BioSante from Antares Pharma Inc. (Amex:AIS - News).
<<