Ortho Biotech Products, L.P. Files sNDA for DOXIL for the Treatment of Advanced Breast Cancer |
Pharmaceuticals | |||
Written by Ortho Biotech | |||
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Bridgewater, NJ, September, 8, 2008: Ortho Biotech Products, L.P. today announced that the Company has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the combination of DOXIL (doxorubicin HCl liposome injection) and Taxotere (docetaxel) for the treatment of women with advanced breast cancer who have received prior anthracycline treatment. The application to the FDA follows the completion of a randomized, parallel-group, open-label, multicenter Phase III clinical trial that evaluated time to progression (TTP) of the disease with combination vs. monotherapy docetaxel treatment. The study met its protocol-specified primary endpoint demonstrating that the DOXIL-docetaxel combination had a statistically significant improvement in TTP as compared to docetaxel alone. Secondary endpoints included overall survival, response rates and safety."This is an important milestone in the development of DOXIL as we continue to demonstrate efficacy and safety of this agent across multiple tumor types," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products, L.P. "We look forward to working with the FDA throughout the regulatory review process to provide this new DOXIL treatment option for advanced stage breast cancer patients who have relapsed after receiving prior anthracycline-containing adjuvant/neoadjuvant therapy." The study results have been selected for oral presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS) in December. According to the National Cancer Institute, there will be an estimated 184,450 new cases of breast cancer and 40,930 deaths from breast cancer in the United States in 2008. About DOXILDOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum based therapy. DOXIL in combination with VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy. DOXIL is also indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. IMPORTANT SAFETY INFORMATIONBOXED WARNINGS
Contraindications
Please see accompanying full Prescribing Information, including Boxed WARNINGS. About Ortho Biotech Products, L.P.Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit http://www.orthobiotech.com. Ortho Biotech Products, L.P. is a member of the Johnson & Johnson family of companies. Forward-Looking StatementThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments. CONTACTMedia, Kassy McGourty for Ortho Biotech Products, L.P.,
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