Savient Pharmaceuticals Receives FDA Approval to Market Soltamox
The First Oral Liquid Tamoxifen in U.S.; U.K.-based Liquids Manufacturing Facility Meets the FDA's Current Good Manufacturing Practices
EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Oct 31, 2005 - Savient Pharmaceuticals, Inc. (NASDAQ: SVNTE), an emerging specialty pharmaceutical company engaged in developing, manufacturing and marketing pharmaceutical products that address unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Soltamox (tamoxifen oral solution) for the treatment of breast cancer in adjuvant and metastatic settings and to reduce risks of breast cancer in women with ductal carcinoma in situ (DCIS) and reduction of breast cancer incidence in women with high risk of breast cancer. Soltamox is the product of Savient's wholly-owned subsidiary, Rosemont Pharmaceuticals Ltd. located in Leeds, U.K.
Soltamox represents the first oral liquid product entry into the U.S. from Savient's wholly-owned U.K. subsidiary and it will be the first oral solution of tamoxifen available in the United States. Soltamox is currently sold in the U.K., Ireland and Germany.
The Company is currently in discussions with potential partners to form an alliance to market Soltamox in the United States and expects to conclude negotiations early in 2006.
Christopher Clement, Savient's President and Chief Executive Officers, said, "The approval of Soltamox marks a significant milestone for Savient and represents a major step in the advancement of our strategic plan to position the Company as an emerging pharmaceutical company. Soltamox is the first of Rosemont's products to be introduced into the United States as we seek to expand the geographic reach of our oral liquids pharmaceutical business. This approval follows the FDA review of our U.K. manufacturing facility and establishes the regulatory pathway for additional Rosemont products to follow into the U.S. market as we continue to enhance the value of this asset."
Tamoxifen is a cytostatic estrogen receptor antagonist used extensively for the treatment and prevention of breast cancer. Soltamox is the only oral liquid presentation licensed in the U.K., Ireland, Germany and now in the U.S. Rosemont Pharmaceuticals, Ltd. holds a global portfolio of patents covering this product.
Important safety information for Soltamox
Use of Soltamox in risk reduction setting (women at high risk for cancer and women with DCIS) has shown to cause cancer of the uterus, stroke, and blood clots. The benefits of Soltamox outweigh its risks in women already diagnosed with breast cancer. Soltamox should not be used in women who require concomitant use of coumarin-type anticoagulant, or in women with history of deep vein thrombosis or pulmonary embolus. Women who are pregnant or plan to become pregnant should not take Soltamox. Cataracts and cataract surgery can also occur more frequently with Soltamox. The most frequently reported adverse reactions with Soltamox were hot flashes and vaginal discharge.
Posted: October 2005