ASCEND Therapeutics files patent applications for drug planned to treat benign breast disease.

ASCEND Therapeutics (Herndon, VA) announced that it has filed a patent application for both the pharmaceutical composition of TamoGel (4-hydroxytamoxifen gel) and the gel's use for the treatment of benign breast disease.

The patents provide protection for ASCEND's transdermal approach to the treatment of chronic conditions like benign breast disease, and solidify the company's proprietary technology position within the breast health therapy market.

Each year approximately 3 million women will experience a first incidence of benign breast disease. The term benign breast disease encompasses a number of nonproliferative and proliferative breast changes and includes, among other conditions, adenosis, cysts, benign tumors, and atypical hyperplasia. Most women who experience one incidence of benign breast disease will experience additional recurrences in their lifetime. Furthermore, women with this condition have been shown to be at greater risk for the development of breast cancer. Approximately 700,000 biopsies are performed on women each year to evaluate if certain forms of breast disease (such as cysts or tumors) are benign or malignant. While 80% of these biopsies are non-cancerous, the procedure causes significant anxiety in patients and cost to the medical system.

Currently under investigation for the treatment of both benign and malignant breast conditions, TamoGel is a new estrogen inhibitor formulated as a gel for transdermal delivery to the breast. TamoGel's active ingredient, 4-hydroxytamoxifen, is the most active metabolite of the FDA-approved drug tamoxifen, a widely-prescribed adjuvant therapy for breast cancer. In a recent study by Dr. Elizabeth Tan-Chiu of the Cancer Research Network tamoxifen has been proven to reduce the risk of benign breast disease by 28%. The same study demonstrated that tamoxifen reduced the incidence of both invasive and noninvasive breast cancer in women with benign breast disease.

"Our patent portfolio includes patent applications regarding the treatment of cyclic breast pain, a condition often associated with certain forms of benign breast disease that affects approximately 12 million premenoupausal women," said Jay Bua, chief executive officer of ASCEND. "In filing these patent applications, we have continued a process that we hope will eventually lead to a non-invasive solution for treating benign breast disease, and ultimately to the prevention of breast cancer."

ASCEND has employed a tiered strategy to protect the company's intellectual property, applying for patents to cover both the composition and methods of use of a specific product. There are currently two products in the pipeline; both are in clinical trials. ASCEND expects to have its first products on the market in 2008.

ASCEND Therapeutics is a biopharmaceutical company focused on the use of transdermal drug delivery technology to overcome therapeutic barriers and raise the standard of care for certain chronic conditions.

ASCEND Therapeutics

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www.ascendtherapeutics.com