23-Oct-07: The Company announced receipt of notification from The NASDAQ Stock Market LLC® that the Company’s common stock is approved for listing on The NASDAQ Global Market. The Company’s board of directors approved the decision to switch the listing of BioSante’s common stock from The American Stock Exchange to The NASDAQ Stock Global Market LLC®. BioSante currently is going through all the required regulatory processes associated with the switch and expects its common stock to begin trading on NASDAQ under the symbol BPAX in early to mid-November 2007.
“This decision was reached after careful consideration of capital market alternatives and an analysis of the electronic market model, which provides increased visibility and liquidity to our investors,” said Stephen M. Simes, BioSante’s president and chief executive officer. “We wish to thank The American Stock Exchange as well as our specialist on AMEX, Cohen Specialists, for the years of support and orderly trading.”
“We believe that NASDAQ’s electronic multiple market maker structure will provide BioSante with enhanced exposure and liquidity, while at the same time provide investors with the fastest execution and lowest cost per trade,” said Phillip Donenberg, BioSante’s chief financial officer. “This makes the move to NASDAQ a logical step and we expect a very orderly transfer.”
4-Oct-07: The Company reported that it has successfully completed validation studies of LibiGel® for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder. The data were presented in early October at the annual meeting of the North American Menopause Society in Dallas, Texas. As per FDA published guidance for patient reported outcome (PRO) studies, the pivotal efficacy studies of LibiGel® require the use of validated methods to measure sexual events and sexual desire, the primary patient reported endpoints. The Company has completed validation studies of a patient diary to measure the number of satisfying sexual events and level of sexual desire. The Company worked with FDA's division of reproductive and urologic products and followed the FDA's guidance document on validation of PRO instruments in completing studies to assure the accuracy, completeness and discriminatory validity of the patient diary. The BioSante inventory of sexual events and desire (ISED) was able to differentiate between women with hypoactive sexual desire disorder (HSDD) and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire (p less than 0.001).
Stephen Simes, president and CEO of BioSante, said: "We are pleased with these results. Patient reported outcome tools are difficult to validate and these results allow us to confidently move forward with the pivotal efficacy studies for the development and potential approval of LibiGel® in the treatment of female sexual dysfunction, an underserved market in the US since no pharmaceutical product is approved for its treatment. BioSante is committed to the development of LibiGel® for FSD which may ultimately be the first product approved by the FDA for this treatment in the US.
11-Sep-07: The Company announced that it has received clarity from and is in agreement with the FDA on key requirements for the development and approval of LibiGel® in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD). The Company met with FDA representatives from the Division of Reproductive and Urologic Products, the Division of Cardio-Renal Products, and the Office of Biometrics III (Statistics) earlier this summer. The primary focus of the meeting was the Company’s LibiGel® safety study protocol to evaluate the cardiovascular risk of using testosterone in women, a key pre-approval concern of the FDA. The study protocol presented by the Company was based on previous company meetings and discussions with the FDA.
"We are quite gratified by the outcome of our communications with the FDA," said Stephen M. Simes, BioSante's president & CEO. "We were confident that we had submitted a proposal that provided the depth and scope of study requested by the FDA. The agreement with FDA has reaffirmed our long-held belief that development of LibiGel® could be both reasonable and affordable from both the financial and timeline aspects. We have received written FDA meeting minutes that provide us with a clearly defined LibiGel® development path that can lead to the approval of LibiGel® for the treatment of FSD. In the US, no pharmaceutical product is approved for the treatment of FSD making this a truly underserved market. BioSante is committed to the development of LibiGel® which ultimately may be the first product approved by the FDA for this treatment in the U.S."
In addition to two Phase 3 efficacy trials, the Company will conduct one Phase 3 cardiovascular safety study. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel® or placebo for 12 months. A new drug application (NDA) can be filed and reviewed by FDA, possibly leading to approval of LibiGel®, at that time. After NDA submission and potential approval, the Company will continue to follow the women enrolled in the study for an additional four years. The LibiGel® safety study will track a list of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least one cardiovascular risk factor including hypertension and diabetes. The Company plans to initiate this Phase 3 safety study by year-end 2007 or in early 2008. 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.
The Phase 3 efficacy trials of LibiGel® in the treatment of FSD, one of which has been initiated, 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 trial already initiated is being conducted under a Phase III protocol reviewed by and on file with the FDA and in which written FDA comments have been received and incorporated. The Company hopes to initiate the second Phase 3 efficacy trial by year-end 2007 or in early 2008.
October 28, 2007
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