Nippon Shinyaku Co., Ltd. Receives Approval to Market TRISENOX(R) in Japan
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.
About TRISENOX(R)
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
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 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. |
