(NPRO / Paclitaxel)
OK, it's a generic, but it's nice to have something to celebrate...
ABBOTT PARK, Ill., and BOULDER, Colo., May 8 /PRNewswire-FirstCall/ -- Abbott Laboratories (NYSE: ABT - news) and NaPro BioTherapeutics, Inc. (Nasdaq: NPRO - news) announced today that they have received approval from the U.S. Food and Drug Administration (FDA) to market Paclitaxel Injection, the most widely used anticancer compound in the United States.
Paclitaxel is equivalent to Bristol-Myers Squibb's TAXOL® (paclitaxel) Injection, an antitumor product indicated for the treatment of metastatic carcinoma of the ovary after the failure of first-line or subsequent chemotherapy. Paclitaxel is also indicated for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease.
"We are pleased to be able to offer a high quality alternative for paclitaxel patients," said Christopher B. Begley, senior vice president, hospital products, Abbott Laboratories. "This approval further demonstrates Abbott's company-wide commitment to the oncology community and bringing specialty generic products to market."
Leonard P. Shaykin, chairman and chief executive officer, NaPro BioTherapeutics, commented, "This approval is a milestone for NaPro and adds the U.S. market to approximately 25 other countries in which NaPro's formulation of paclitaxel is already distributed. We are proud of this accomplishment, and look forward to advancing the other therapeutics in our pipeline, including both natural products and other anticancer compounds, as well as our unique gene alteration technology."
Abbott and NaPro have been collaborating since July 1999 to provide paclitaxel to the U.S. market. NaPro is responsible for acquiring and processing the raw material primarily from its plantations of cultivated yew trees for the formulation of a high quality, active drug substance using its patented formulation methods. Abbott is responsible for the filling, finishing, distributing and marketing of final paclitaxel product consistent with the high quality standards that have made Abbott the largest intravenous medication supplier in the U.S.
Through a cross-license agreement completed last year with Bristol-Myers Squibb, NaPro and Abbott have unrestricted access to the U.S. market for Paclitaxel Injection. Abbott will begin product shipments immediately to meet anticipated customer demand. Abbott and NaPro will supply Paclitaxel Injection in three sizes: 30 mg, 100 mg, and 300 mg multi-dose vials... |
