Canadian family pharmacy is focused on developing innovative products for male/female sexual health. The current market for testosterone and estrogen products is over $2.5 billion dollars in the U.S. alone, with estimates for female sexual dysfunction (FSD) potentially adding more than $2.0 billion. In addition, the current market for hormonal contraception is approximately $3.0 billion. The market for oncology products is over $20 billion.
BioSante’s lead near term product in development is LibiGel® (testosterone gel) for the treatment of FSD, specifically hypoactive sexual desire disorder (HSDD). LibiGel’s clinical development program consists of two completed Phase III safety and efficacy trials, conducted according to a Special Protocol Assessment (SPA) agreement with the FDA. Each double-blind placebo-controlled trial enrolled over 500 surgically meno–pausal women for six months of treatment. Ongoing is one Phase III cardiovascular and breast cancer safety study, which has completed enroll–ment of 3,656 women with cardiovascular risk factors. A completed LibiGel Phase II clinical trial has shown excellent results with a significant 238% increase in the total number of satisfying sexual events. There are currently no pharmaceutical products approved for the treatment of HSDD in the U.S., however over 4 million prescriptions for testosterone were written off-label by physicians for women in 2010. A new drug application (NDA) is targeted to be submitted in 2012.
BioSante’s marketed product, ElestrinTM, is FDA approved to reduce hot flashes in menopausal women. The lower of the two approved Elestrin doses is 67% lower than the lowest dose transdermal estradiol patch available for the treatment of hot flashes. Elestrin is marketed in the U.S. by Azur Pharma.
Bio-T-Gel™ for the treatment of male hypogonadism, or low testosterone, has an NDA pending; to be marketed by Teva Pharmaceuticals. The current testosterone gel market in the U.S. for male hypogonadism is over $1.3 billion.
BioSante is focused primarily on LibiGel, however, the company also is seeking future development opportunities for its cancer vaccines, which are non patient-specific therapies comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety and are administered via intradermal injections on an outpatient basis. Currently, several of BioSante’s cancer immunotherapies are in Phase II clinical trials at Johns Hopkins Cancer Center and BioSante has been granted FDA Orphan Drug designation for its pancreatic cancer, acute myloid leukemia, chronic myeloid leukemia, and melanoma vaccines