SEATTLE, Oct. 25 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) announced that Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) received approval from the Japanese Ministry of Health to market TRISENOX(R) (arsenic trioxide) for patients with relapsed or refractory acute promyelocytic leukemia (APL) in Japan. Nippon Shinyaku expects to launch TRISENOX(R) in Japan in the coming months after receiving pricing approval. Under the marketing and distribution agreement, CTI Technologies Inc., a wholly owned subsidiary of CTI, will receive a $500,000 milestone payment from Nippon Shinyaku as a result of receiving approval to market TRISENOX(R) in Japan. CTI also has rights to future payments based on the achievement of milestones and from royalties on product sales.
"Nippon Shinyaku is an established leader in the field of hematological malignancy and with over 500 sales representatives is well positioned to maximize the potential of TRISENOX(R) in Japan," stated James A. Bianco, president and CEO of CTI.
The president of Nippon Shinyaku, Kazuto Hatsuyama said, "CTI has been a tremendous partner throughout the filing process and we are very excited to bring TRISENOX(R) to relapsed/refractory APL patients in Japan."
About Acute Promyelocytic Leukemia (APL)
APL, one of eight subtypes of acute myeloid leukemia (AML), is a malignant disorder of white blood cells that can affect patients of any age. APL is characterized by a specific chromosomal abnormality -- a switch, or translocation, of genetic material from chromosome 17 to chromosome 15. This genetic alteration results in an abnormal protein that inhibits normal cell growth and prevents maturation of white blood cell precursors in the bone marrow, ultimately resulting in cancer. The standard treatment for newly diagnosed APL has been a combination of chemotherapy and all-trans-retinoic acid (ATRA), which results in a complete response in 70 to 90 percent of newly diagnosed patients. However, approximately 20 to 30 percent of patients who receive this treatment regimen relapse. This poor response to drug therapy has led to the use of allogenic stem cell transplantation (the transfer of healthy, young cells from the bone marrow or bloodstream of a donor) to prolong survival. TRISENOX provides another treatment option for this patient population.
TRISENOX(R) (arsenic trioxide) is marketed by CTI. TRISENOX was approved for marketing in 2000 by the U.S. Food and Drug Administration to treat patients with relapsed or refractory acute promyelocytic leukemia (APL), a rare, life-threatening form of cancer of the blood. TRISENOX was granted marketing authorization from the European Commission in March 2002. APL, one of eight subtypes of acute myeloid leukemia (AML), represents 10-15 percent of the more than 20,000 patients diagnosed with AML each year. TRISENOX is currently being studied in more than 40 clinical and investigator-sponsored trials in a variety of cancers.
U.S. marketing approval for TRISENOX was granted based on results from a U.S. multicenter study in which 40 relapsed APL patients were treated with TRISENOX 0.15 mg/kg until bone marrow remission or a maximum of 60 days. Thirty-four patients (85 percent) achieved complete remission. When the results for these 40 patients were combined with those for the 12 patients in a pilot trial, an overall response rate of 87 percent was observed.
WARNING: TRISENOX should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. Some patients with APL treated with TRISENOX have experienced APL differentiation syndrome -- with symptoms similar to retinoic acid-acute promyelocytic leukemia (RA-APL) syndrome. Arsenic trioxide can cause QT prolongation (which can lead to torsade de pointes) and complete atrioventricular block.
The most common adverse events associated with TRISENOX have been generally manageable, reversible and usually did not require interruption of therapy. These have included hypokalemia, hypermagnesemia, hyperglycemia and thrombocytopenia as reported in 13 percent of the patients (n=40). Abdominal pain, dyspnea, hypoxia, bone pain and neutropenia were reported in 10 percent of these patients, while arthralgia, febrile neutropenia and disseminated intravascular coagulation were reported in eight percent of patients.
About Nippon Shinyaku
Nippon Shinyaku, based in Kyoto, Japan, was founded in 1919 and currently employs about 1800 employees. In 2003, Nippon Shinyaku recorded net income of $14 million ($0.20 per share) on revenues of $484 million. In addition to its other pharmaceutical products, Nippon Shinyaku currently markets Cyclocide and Cyclocide N for acute leukemia, malignant lymphoma, and other solid tumors, and Estracyt for prostate cancer. For additional information please visit http://www.nippon-shinyaku.co.jp/.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com/. This announcement includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with TRISENOX in particular including, without limitation, the inability of Nippon Shinyaku to receive pricing approval for the sale of TRISENOX, the ability of Nippon Shinyaku to successfully commercialize and market TRISENOX in Japan, the potential failure of TRISENOX to remain safe and effective for treatment of APL, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of producing and selling TRISENOX, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q.
Cell Therapeutics, Inc.