ALISO VIEJO, Calif., June 8 Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that the United Kingdom Patent Office has granted a U.K. patent on the Company's TLE3 biomarker, a marker which may be used to predict which cancer patients will respond favorably to taxane therapy. In addition, the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a U.S. patent on the TLE3 biomarker. Other patents for the TLE3 biomarker are pending in the U.S., Canada, Japan, China, India and elsewhere in Europe.
The U.S. patent will cover uses of the TLE3 biomarker in breast cancer. The U.K. patent covers uses of TLE3 in breast, lung and ovarian cancers.
Taxanes are important cancer therapeutics which, in combination with other cancer therapies, can markedly improve a patient's response rate to therapy. However, taxanes also carry with them a significant incidence of severe side effects, making it important to identify which patients will most likely benefit from the therapy.
"Given the frequent prescription of taxanes in the U.S., the U.K. and elsewhere in Europe and the world, we are very excited about the granting of these patents and the protection they provide our taxane sensitivity marker," said Clarient Vice Chairman and CEO Ron Andrews.
The TLE3 biomarker is the anchor of Clarient's proprietary taxane predictive product line that includes an array of tests created for lung, ovarian and breast cancers, among others. Clarient's Ovatax(TM) assay for ovarian cancer and Mammotax(TM) assay for breast cancer are expected to be launched in the fourth quarter of 2010, and launch of its Pulmotax(TM) assay for lung cancer is expected in 2011.
"The allowed U.S. patent for Mammotax will give Clarient immediate protection for the first taxane sensitivity product we plan to bring to market," said Rob Seitz, Clarient's Senior Vice President for Technology Assessment and one of the inventors on the patent. "Furthermore, it validates our overall patent strategy for this important biomarker, giving Clarient greater confidence that our efforts in the entire TLE3 product portfolio will receive intellectual property protection."
Commenting further, Andrews added, "We believe our taxane product line further differentiates Clarient in the cancer diagnostics marketplace. The fact that TLE3 can identify the responders to taxanes provides clinicians with an important piece of information which may allow them to determine whether a patient should receive a taxane as part of a therapeutic regimen. Given the toxicity of taxanes, there are significant hospital and emergency room costs associated with its use in a high percentage of patients. Therefore, it also has important health economic ramifications for managed care organizations and other payors, potentially allowing them to save millions of dollars in unnecessary costs for non-beneficial treatments so the patient's cancer can be managed in a more effective and economically efficient way."
Clarient is currently in discussions with several international partners to expand the reach of the TLE3 products outside the U.S., including the possible creation of diagnostic test kits for distribution in key world markets.
The TLE3 U.K. patent GB2460769, was granted on May 4, 2010 and published in the Patents Journal on June 2, 2010. The Notice of Allowance from the USPTO for U.S. Application No. 12/578255 is dated June 3, 2010. The patents will issue in the name of Applied Genomics, Inc., a wholly-owned subsidiary of Clarient.
Clarient combines innovative diagnostic technologies with world-class pathology expertise to assess and characterize cancer. Clarient's mission is to become the leader in cancer diagnostics by collaborating with the healthcare community to translate cancer research and development into better patient care. Clarient's principal customers include pathologists, oncologists, hospitals and biopharmaceutical companies. The rise of individualized medicine has created the need for a centralized resource which provides leading oncology diagnostic technologies, such as flow cytometry and molecular testing. Clarient is that resource, having created a state-of-the-art commercial cancer laboratory, which provides advanced oncology testing and diagnostic services. Resulting diagnostic reports and analyses are made available to customers through Clarient's Internet-based portal, PATHSiTE®. Clarient also plans to develop and market new, proprietary "companion" diagnostic markers for therapeutics in breast, prostate, ovarian, lung and colon cancers, and leukemia and lymphoma. www.clarientinc.com
Forward Looking Statements
Certain statements herein regarding Clarient, Inc. contain forward-looking statements that involve risks and uncertainty. Future events and Clarient's actual results could differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to: Clarient's ability to continue to develop and expand its diagnostic services business, uncertainties inherent in Clarient's product development programs, Clarient's ability to expand and maintain a successful sales and marketing organization, Clarient's ability to obtain additional financing on acceptable terms or at all, uncertainty of success in identifying and developing new diagnostic tests or novel markers, Clarient's ability to fund development of new diagnostic tests and novel markers and the amount of resources Clarient determines to apply to novel marker development and commercialization, failure to obtain FDA clearance or approval for particular applications, Clarient's ability to compete with other technologies and with emerging competitors in novel cancer diagnostics and dependence on third parties for collaboration in developing new tests, Clarient's ability to obtain adequate patent protection covering its use of the TLE3 biomarker, the risk to Clarient of infringement claims and the possibility of the need to license intellectual property from third parties to avoid or settle such claims, Clarient's ability to successfully validate and commercialize AGI's product offerings, Clarient's ability to commercially launch the Mammotax, Ovatax and Pulmotax tests, and other tests for taxane sensitivity in breast cancer and other carcinomas, beginning in the fourth quarter of 2010, and risks detailed from time to time in Clarient's SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K.
Clarient does not assume any obligation to update any forward-looking statements or other information contained in this document.
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