BioSante Pharmaceuticals Inc has licensed three patents encompassing new combinations of hormone therapies, known as triple hormone therapy, by any route of administration from Wake Forest University School of Medicine. Also included in the license is an option to use triple hormones in contraceptives.

The Wake Forest patents cover novel combinations of estrogens and progestins with androgens, such as testosterone, which may have beneficial effects in women. Currently, estrogen plus progestin is indicated for the treatment of menopausal symptoms, including hot flashes and vaginal atrophy, for women with an intact uterus. Testosterone is thought to further alleviate symptoms of menopause and female sexual dysfunction in postmenopausal women.

"This license agreement with Wake Forest for new combination hormone therapies is a very valuable addition to BioSante's hormone therapy product pipeline in development," said Stephen M. Simes, president and chief executive officer of BioSante. "Our products are topical gel formulations for men and women. These gels provide continuous systemic levels of the hormones, which may result in less potential for side effects. With more attention being focused on the safety and efficacy of hormone therapy products, especially among women and their health care providers, we believe BioSante's portfolio of hormone therapy gel products positions us well to gain acceptance and market share in the treatment of menopausal symptoms, among other indications."

BioSante currently is testing Bio-T-Gel (gel formulations of testosterone for men), Bio-E-Gel (estradiol for women) and LibiGel (testosterone for treatment of female sexual dysfunction), and also is developing combinations of these hormones.

"The license allows us to combine the three hormones for use as triple hormone therapy in women," said Simes. The company plans to test the triple hormone therapy in clinical trials, and the patents are expected to provide BioSante with a proprietary position for triple hormone therapy by any route of administration. The hormone therapy market in the United States alone is approximately $2.5 billion annually.

Dean Stell, assistant director of Technology Asset Management for Wake Forest, said, "BioSante is a very natural fit for this technology given its hormone therapy product pipeline and drug delivery technology."

"Among the key benefits of the triple hormone therapy versus using the hormones separately is the potential for lower cost to the patient and greater convenience from using one product versus two or three," said Simes. "The potential for using lower doses of each hormone, when used in triple hormone therapy, may possibly improve the safety profile of hormone therapy."
The technology was developed through research at the Comparative Medicine Clinical Research Center by two former comparative medicine faculty members, Dr. Manuel Jayo and Dr. Claude L. Hughes, Jr., who also was an associate professor of obstetrics and gynecology. Cedars-Sinai Medical Center in Los Angeles also participated in the development of the technology.