As part of its campaign against generic versions of multiple sclerosis treatment Copaxone, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today published data that demonstrates significant differences in biological and immunological effects between the branded drug and a generic version. The research carried out on mice and not humans was conducted by Teva and genomic research company Immuneering.
The research published in the scientific periodical PLOS ONE compares Teva's Copaxone with a generic version already being marketed in India by Natco Pharma Ltd., one of the companies expected to launch a generic version in the US, when the patent expires and marketing approval is received.
Teva says the research results, "have potential clinical ramifications and that the study, "demonstrated a predictable and therapeutically-aligned impact of Copaxone on genes associated with key immune response-related cells. This is in contrast to a significantly different and irregular impact on genes associated with these cells by the purported generic GA."
Teva added, "The cells identified in this study included regulatory T cells (Tregs), which control immune and auto-immune responses, and myeloid lineage cells - the precursors of many immune response cells. The gene expression impact and variability of the purported generic GA indicates different biological effects of these drugs."
Teva has for some time been insisting that Copaxone is a complex drug and that clinical trials are required for generic versions before they receive marketing approval.
Teva president of global R&D and chief scientific officer Dr. Michael Hayden said, "The data from this paper shows the possible significant ramifications of changes in physiochemical properties between Copaxone and a purported generic GA. This study suggests a distinct potential difference in the impact of a purported generic GA on the immune system of patients, with possible implications on efficacy and safety in RRMS patients. Teva believes the only way to truly understand the impact of these differences is by conducting a full battery of clinical studies."
Published by Globes [online], Israel business news - www.globes-online.com - on January 13, 2014
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