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
