Preliminary topline results from Teva, CureTech's CT-011 Phase II trial in Diffuse Large B Cell Lymphoma

May 17 2011

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and CureTech, a portfolio company of Teva and Clal Biotechnology Industries announced today preliminary topline results for CT-011, an investigational anti-PD-1 monoclonal antibody. CT-011 met the primary endpoint of improved progression-free survival (PFS), in a Phase II clinical trial in patients with Diffuse Large B Cell Lymphoma (DLBCL) following autologous stem cell transplantation. Statistically significant results have also been achieved in the secondary endpoint of Overall Survival (OS).

Preliminary analyses indicate that 70% of the patients treated with CT-011 were progression-free at the end of the follow-up period, as compared to only 47% in the historical control. Furthermore, 84% of the patients treated with CT-011 were alive by the end of the follow-up period, compared to only 62% in the historical control.

"We are very pleased to have achieved this major milestone in the clinical development of CT-011," said Dr. Michael Schickler, CEO of CureTech. "Following the final results, CureTech will be ready to commence Phase III regulatory studies for the high unmet need in this severe indication."

"DLBCL is an aggressive type of non-Hodgkin's Lymphoma (NHL) affecting about 40% of all NHL patients," said Jacob M Rowe MD, Director, Department of Hematology, Shaare Zedek Medical Center in Jerusalem, Israel. "I am very encouraged by the results of this trial and am certain that if these results will be confirmed in future controlled Phase III studies, CT-011, a truly novel anti cancer therapy will improve the lives of many DLBCL patients."

"The results of this early study are exciting," said Arnon Nagler, MD, Director of the Division of Hematology, BMT and CBB at the Chaim Sheba Medical Center, Israel and co-International Principal Investigator in the study. "There is a significant unmet medical need for therapies that could benefit these patients and I am pleased that such a promising treatment came out of Israeli science."

Following the successful completion of CureTech's first Phase I study in 2006, Teva took an equity position in the Company, and upon subsequent investments, Teva now holds approximately 33% of CureTech and has an option to further invest in the Company. This opportunity is one of many initiatives in which Teva has invested in recent years. The success of this significant Phase II study encourages Teva to continue leveraging Israeli science.

"When we expanded our collaboration with CureTech in 2008, we did so with the intention of building on CT-011's success up to that point, and we are incredibly pleased with the Phase II data announced today," said Dr. Aharon Schwartz, Head of Teva's Innovative Ventures. "Our collaboration with CureTech is just one of many oncology investments and alliances that we have made over the last several years in an effort to build out our portfolio of specialty products within niche therapeutic areas like oncology."