January 06, 2015
Kite Pharma Granted Orphan Drug Designation in the European Union for KTE-C19, Kite's Lead Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy
SANTA MONICA, Calif., Jan. 6, 2015 (GLOBE NEWSWIRE) -- Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the European Commission (EC), acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has designated KTE-C19 as an orphan medicinal product for the treatment of diffuse large B cell lymphoma (DLBCL). Kite previously announced in March 2014 that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for KTE-C19 for the treatment of DLBCL. Further, Kite has filed an investigational new drug (IND) application to conduct a Phase 1/2 clinical trial for KTE-C19 with the FDA.
"We are pleased with the approval of orphan drug designation for KTE-C19 in the EU, another important milestone for Kite Pharma and for the progress of our lead program," said Arie Belldegrun, M.D., President and Chief Executive Officer of Kite Pharma. "DLBCL is an aggressive blood cancer that represents a significant unmet need for those patients with refractory or relapsed disease. The KTE-C19 program is part of Kite's broad commitment to delivering innovative therapies that potentially can transform the lives of cancer patients around the world."
Orphan drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
KTE-C19 is Kite Pharma's lead product candidate in which a patient's T cells are genetically modified using a gammaretroviral vector to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on eACT™ designed to restore the immune system's ability to recognize and eradicate tumors. In partnership with the NCI Surgery Branch through a Cooperative Research and Development Agreement (CRADA), Kite is advancing a pipeline of proprietary eACT™ product candidates, both CAR (chimeric antigen receptor) and TCR (T cell receptor) products, directed to a wide range of cancer indications. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and willingness of the NCI to continue research and development activities relating to eACT™ pursuant to the CRADA; and the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing a clinical trial of KTE-C19. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended September 30, 2014. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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