Teva Pharmaceutical Industries said today it ended a nearly seven-year collaboration with CureTech on the humanized monoclonal antibody CT-011 being for blood malignancies and solid tumors, after announcing plans to invest up to $108.5 million in the company and its R&D.
The collaboration cutoff appears to be Teva President and CEO Jeremy Levin, Ph.D.’s latest move in repositioning the generics giant into more of a branded-drug company with expanded over-the-counter offerings and more presence in emerging markets, especially China. The company faces 2015 loss of patent protection for its flagship branded drug, Copaxone for multiple sclerosis.
Speaking with Reuters in December, Levin and Michael Hayden, M.D., Ph.D., the company’s president and CEO of R&D and chief R&D officer, discussed plans to shift drug development away from developing new molecules, toward “new therapeutic entities” or NTEs that could be new uses, formulations, delivery methods, or combinations of existing products. Dr. Hayden said at the time that NTEs would provide higher returns on investment and much lower risks than developing new molecules. Teva has set a goal of approving development of 10–15 NTEs in 2013 and getting them to market starting in 2016.
Teva and CureTech first hooked up in 2006, when Teva invested an initial $6 million and received an option to invest up to an additional $23 million in CureTech tied to undisclosed milestones, and thus increase its stake in the company. CT-011 is designed to interact with PD-1, a B7 receptor-family-associated protein, to show anticancer immune response against a wide variety of mouse and human tumors.
Two years later, Teva agreed to spend another $10.5 million on an expanded collaboration that entailed supporting an ongoing Phase II study in diffuse large B cell lymphoma (DLBCL) as well as a new Phase II study in previously untreated patients with metastatic colorectal cancer.
In 2011 following promising Phase II results for CT-011 in 2011, it agreed to invest another $19 million in CureTech and fund up to $50 million of its R&D program. Teva’s spending raised its Curetech ownership to 75%, with an option for full ownership.
At the time, Teva said it was looking to expand its branded-drug business as well as expand into specialty therapeutic indications such as cancer. To that end, it announced plans to launch a Phase III trial in DLBCL—the indication for which it saw the encouraging Phase II results—as well as continue the ongoing Phase II study for colorectal cancer, and launch a third Phase II study in metastatic melanoma.
A terse statement from Teva suggests that the trials never reached Phase III: “CT-011 was assessed in several Phase I and II clinical studies in various cancer indications including diffuse large B-cell lymphoma (DLBCL), colon cancer, metastatic melanoma, and additional investigator initiated studies.”
Teva also quoted Dr. Hayden as saying the decision to end work with CureTech stemmed from “the process of conducting a disciplined review of our pipeline.”
"As we looked closely at CT-011 and the most recent clinical and biochemical data, we have made the strategic decision to invest our resources elsewhere where we can have the most impact for patients,” Dr. Hayden added.
Teva did say, however, that it would take a $109 million noncash charge against earnings stemming from what it called the impairment of its investment in CureTech.