September 21, 2010 –InvestorIdeas.com, an investor research portal covering leading sectors including biotech stocks and pharma stocks, presents a Q&a interview with BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for investors following the sector.
Q: Investorideas.com
Can you give investors a brief overview of your current focus in the pharmaceutical market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Today, BioSante is focused on development of our LibiGel which is in late-stage Phase III clinical studies for the treatment of female sexual dysfunction, for which there is no FDA approved pharmaceutical product. In addition we have a full pipeline of pharmaceutical products in clinical trials for various indications focused on women’s health, as well as a portfolio of cancer vaccines being developed.
Q: Investorideas.com
One of your leading products, LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) is positioned to be a market leader and a pioneer in the making. can you discuss the potential in terms of market value and how it compares to Viagra breaking into the male market over twelve years ago?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Interestingly and unfortunately women still do not have an FDA approved pharmaceutical product to help with their sexual functioning issues, notwithstanding the fact that men have had Viagra for over 12 years. BioSante hopes to change that with our LibiGel. we expect that LibiGel will be the first product approved for the treatment of this true unmet medical need of hypoactive sexual desire disorder. Market research indicates that the market for a product for women actually is larger than the male products which today are about $2 billion per year in sales.
Q: Investorideas.com
LibiGel is currently in late-stage Phase III clinical studies. can you give investors a brief overview of what is next and the potential timelines?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
LibiGel is in three Phase III clinical studies. we hope to complete enrollment in these studies this year and to submit a new drug application (NDA) to the FDA by the end of next year for an approval an d launch in 2012. The time has come for women to have a product for treatment of this unmet medical need and BioSante is committed to bringing LibiGel to market for the treatment of females sexual dysfunction.
Q: Investorideas.com
For Investors following the LibiGel clinical development program, can you give investors perspective and confidence on the company’s ability to move forward from a cash position?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Despite the very difficult markets and economy we all have lived through these last several years, BioSante has raised over $70 million in the last year. as of June 30, 2010 we reported over $40 million in the bank. we burn about $3 million per month conducting the tree LibiGel clinical studies and running our company. Therefore we are in a good financial position to implement the plans I have discussed. we believe our ability to raise a significant sum in these difficult days is a major statement by investors in the potential value of LibiGel for women.
Q: Investorideas.com
Separate fromLibiGel®, your company has products in development for the oncology market. can you give investors a brief update on the status of your cancer vaccines?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
BioSante is in development of a full pipeline of cancer vaccines to treat various forms of cancer. The lead vaccines are for breast cancer, pancreatic cancer and leukemia. we have received orphan drug designation for the latter two forms of cancer which is valuable to BioSante from a commercial point of view. interestingly the cancer vaccines are in about 15 clinical trials today at minimal cost to BioSante since they are funded by others interested in bringing improved cancer therapies to patients in need.
BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three of which have been granted orphan drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies.
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