Key Developments For BioSante Pharmaceuticals, Inc.
BioSante Pharmaceuticals, Inc. (BPAX.O) (Consolidated Issue listed on NASDAQ Global Market)
BioSante Pharmaceuticals, Inc. Comments On Boehringer Ingelheim Clinical Test Results In Treatment of Female Sexual Dysfunction
BioSante Pharmaceuticals, Inc. announced the clinical test results of flibanserin, a drug candidate which treats HSDD by blocking the brain's release of serotonin, a chemical that regulates mood, appetite, sleep and memory and, in time, triggers the production of dopamine. Boehringer has been studying flibanserin in pre-menopausal women. Data, pooled from three Phase III studies, presented from trials in Europe and the U.S., show a statistically significant improvement in satisfying sexual events (SSEs) compared to placebo, with an average difference of 0.70 SSEs per four week period. Treatment with LibiGel in a Phase II double-blind, placebo-controlled, clinical trial, conducted in the U.S., in surgically menopausal women distressed by their low sexual desire and activity, 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% versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05), an average difference of 3.4 SSEs per four week period. 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.
BioSante Pharmaceuticals, Inc. Announces Positive LibiGel Safety Data In Phase III Program
BioSante Pharmaceuticals, Inc. announced positive safety data in its ongoing LibiGel Phase III clinical development program. For the first time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review of unblinded data, the DMC unanimously recommended continuation of the study as described in the study protocol, with no modifications. BioSante reported that the DMC reviewed all unblinded adverse events in the safety study including all serious adverse events and all adverse cardiovascular and breast cancer events in 1,055 women with 883 women-years of exposure. To date, there have been no deaths, one myocardial infarction and only three breast cancers reported. Therefore, in view of the DMC recommendation, the BioSante 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 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 submitted 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.
BioSante Pharmaceuticals, Inc. And Cell Genesys, Inc. Announce Completion Of Merger
BioSante Pharmaceuticals, Inc. and Cell Genesys, Inc. announced the completion of their previously announced merger of Cell Genesys, Inc. with and into BioSante Pharmaceuticals, Inc., with BioSante Pharmaceuticals, Inc. as the surviving company, under which BioSante Pharmaceuticals, Inc. now has acquired all of the outstanding shares of Cell Genesys, Inc. common stock. The combined company`s ownership composition consists of approximately 62% from BioSante Pharmaceuticals, Inc. stockholders and 38% from the former Cell Genesys, Inc. stockholders. Pursuant to the merger, the payment obligations of Cell Genesys, Inc. under its 3.125% convertible senior notes due 2011 and 2013, respectively, were assumed by BioSante Pharmaceuticals, Inc. Prior to the merger, the 2011 and 2013 notes were convertible into common stock of Cell Genesys, Inc. at a conversion price of $9.10 and $0.68, respectively, and upon the merger, pursuant to the indentures governing those notes, the 2011 and 2013 notes became convertible into common stock of BioSante Pharmaceuticals, Inc. at a conversion price of $49.78 and $3.72, respectively.
BioSante Pharmaceuticals, Inc. And Cell Genesys, Inc. Announce Final Exchange Ratio For Merger
BioSante Pharmaceuticals, Inc. and Cell Genesys, Inc. announced that they have determined the final exchange ratio as 0.1828 in connection with merger between the companies. If the merger is completed, Cell Genesys stockholders will receive 0.1828 of a share of BioSante common stock for each share of Cell Genesys common stock they hold immediately prior to the effective time of the merger. The exchange ratio was based on Cell Genesys`s net cash, less certain expenses and liabilities, as of September 20, 2009, a date ten calendar days preceding the anticipated closing date of the merger. The parties determined that Cell Genesys`s net cash as of such determination date was $23.8 million. Since this amount exceeded the applicable net cash target amount of $22.1 million by $1.7 million, the exchange ratio was adjusted upwards from 0.1615 of a share of BioSante common stock to 0.1828 of a share of BioSante common stock. If the merger is completed, BioSante will issue an aggregate of approximately 20.2 million shares of BioSante common stock to holders of Cell Genesys common stock and current BioSante stockholders will own approximately 62% of the outstanding common stock of the combined company and current Cell Genesys stockholders will own approximately 38% of the outstanding common stock of the combined company, assuming the number of outstanding shares of BioSante and Cell Genesys common stock remains unchanged until immediately prior to the effective time of the merger.
BioSante Pharmaceuticals, Inc. Closes $12 Million Registered Direct Offering
BioSante Pharmaceuticals, Inc. announced the closing of the sale, directly to three institutional investors, of an aggregate of 6,000,000 shares of the Company's common stock and warrants to purchase up to 2,400,000 additional shares of its common stock, resulting in gross cash proceeds to the Company of approximately $12.0 million. The Company expects to receive net proceeds of approximately $11.1 million after deducting placement agent fees and other offering expenses. Each unit, consisting of one share of common stock and a warrant to purchase approximately 0.40 of a share of common stock, was sold for a purchase price of $2.00. The warrants to purchase additional shares will be exercisable at an exercise price of $2.50 per share beginning immediately and will expire on August 12, 2014. Proceeds from the transaction will be used for general corporate purposes, including to fund the Company's Phase III clinical study program for LibiGel.
