Industry Blog

19
Oct 09

Transformative Times for BioSante Pharmaceuticals

The last 75 days have been transformative for BioSante,” Bill Milling, Sr. Dir Operations for BioSante Pharmaceuticals, Inc. (BPAX) told BioMedReports. Yesterday, the company announced positive safety data in its ongoing LibiGel Phase III clinical development program.

“First we closed a financing in August having raised $12 million,” explained Milling. “We then closed a merger on October 14 which brought in an additional $23 million and added a strong portfolio of cancer vaccines. Yesterday we reported very positive safety data in our LibiGel development program for the treatment of female sexual dysfunction. Overall, we now have enough cash to get through LibiGel clinical data and to an NDA.”

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism and yesterday they 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.

Last week, BioSante and Cell Genesys, Inc. (CEGE) announced the successful completion of their previously announced merger into BioSante, under which BioSante now has acquired all of the outstanding shares of Cell Genesys common stock. That deal was valued at $38 million.

BioSante Pharmaceuticals Inc. said Wednesday that it completed an all-stock buyout of Cell Genesys Inc. and the combined company will focus on developing a topical testosterone gel intended to treat sexual dysfunction in women, but it also plans to develop Cell Genesys’ cancer treatment GVAX. Cell Genesys, based in South San Francisco, Calif., was developing GVAX, as an immune treatment for prostate cancer, but discontinued testing last year after one trial was likely to fail and another had an unexpectedly high rate of patient deaths.

The company said GVAX is now being tested as a potential treatment for pancreatic cancer, leukemia and breast cancer.

BioSante also now owns a stake in Ceregene Inc., a former subsidiary of Cell Genesys, which is developing gene therapies for neurodegenerative disorders.

Several analysts are feeling bullish about the stock and feel it has good potential given it’s current Phrase III trial, cash reserves, latest safety news and the BioVant™ H1N1 adjuvant in their pipeline.

In August, BioSante announced that BioVant™, increased the protective effect of vaccines for multiple flu strains, including a potential new vaccine against H1N1 (swine flu), which resulted in 100 percent protection from symptoms of illness, including weight loss, and death in animal studies.

Source: http://seekingalpha.com

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20
Sep 09

BioSante Pharmaceuticals and Cell Genesys Announce Final Exchange Ratio for Merger

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) and Cell Genesys, Inc. (NASDAQ: CEGE), today announced that they have determined the final exchange ratio as 0.1828 in connection with the previously announced 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. Each company is scheduled to hold a special meeting of stockholders on September 30, 2009 at which time stockholders will be asked to approve the merger. BioSante and Cell Genesys expect to close the proposed merger promptly after such stockholder approvals have been obtained.

The exchange ratio was calculated pursuant to the terms of the definitive merger agreement entered into on June 29, 2009 between BioSante and Cell Genesys and 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 percent of the outstanding common stock of the combined company and current Cell Genesys stockholders will own approximately 38 percent 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.

www.newsticker.welt.de

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