TRISENOX(R) U.S. Patent Allowance Will Extend Exclusivity from 2007 to Late 2018
Tuesday January 27, 7:02 am ET
Resulting Patent Could Add Significant Cumulative Sales Revenues for Trisenox(R)
SEATTLE, Jan. 27 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato: CTIC) announced today that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent application that, when issued, includes coverage directed to CTI's drug TRISENOX® (arsenic trioxide) injection. CTI has an exclusive license to this patent property. Upon issuance, the U.S. patent will extend CTI's U.S. intellectual property position for TRISENOX eleven years beyond the original orphan drug designation that currently expires in 2007.
The resulting patent will allow CTI to invest in label expansion studies in additional diseases, which could add significantly to the annual sales growth of the product. CTI markets TRISENOX in the United States and Europe for the treatment of acute promyelocytic leukemia (APL), a rare cancer of the blood.
"TRISENOX has typically been discounted by Wall Street as a treatment for a rare disease with a small market potential. With exclusivity extended 11 years past the original orphan drug exclusivity period, it now makes sense for us to fully explore the potential benefits of TRISENOX across a larger spectrum of blood related and solid tumor cancers," stated James A. Bianco, President and CEO of CTI. "Without this coverage we would not invest resources investigating the potential for TRISENOX to treat life threatening cancers like melanoma, prostate and brain cancer. This could be worth hundreds of millions of dollars in additional revenue over the course of the new patent life and is a major accomplishment for CTI."
TRISENOX is currently being studied in more than 40 clinical and investigator-sponsored trials and CTI anticipates having more than 60 trials ongoing later this year focusing on the efficacy of TRISENOX in multiple myeloma, myelodysplastic syndrome, non-Hodgkin's lymphoma, hormone refractory prostate cancer, melanoma, glioblastoma, and acute and chronic leukemias. Based on the patent extension, CTI will move forward with plans to initiate pivotal studies of TRISENOX in combination with other agents in hematologic malignancies.
About TRISENOX®
TRISENOX® (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 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. |
