Multiple genes associated with potential therapeutic effects
expressed differently: Gene expression analysis provides insight into
The data, published in the online scientific journal PLOS ONE, are the results of gene expression analysis from mouse splenocytes (white blood cells found in the spleen) exposed to either COPAXONE® or the purported generic GA. 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.
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.
"The data from this paper shows the possible significant ramifications of changes in physiochemical properties between COPAXONE® and a purported generic GA.” Said Dr.
The analysis found that COPAXONE® increases levels of FOXP3 more consistently and effectively than the purported generic GA. FOXP3 is a key factor controlling the development and function of Tregs, which may help suppress harmful autoimmunity in MS patients. Additional genes associated with these beneficial Tregs were also increased to a greater extent by COPAXONE® relative to the purported generic GA. The extent to which this differential impact on Tregs might affect patient response remains unknown.
The purported generic GA was also found to increase the expression of genes associated with myeloid lineage cells, such as monocytes and macrophages, to a greater extent than COPAXONE®. These cells play an important role in the immune systems of healthy people, but can also contribute to the worsening of RRMS. Without clinical trials, the extent to which the increased impact of the purported generic GA on myeloid lineage cells might alter clinical outcomes in RRMS patients remains unknown.
The study also shows that COPAXONE® has a more consistent biological impact across batches than the purported generic GA. A high degree of consistency was found across 34 samples from 30 different COPAXONE® batches. This compares with a high level of inconsistency across only 11 samples representing just 5 different batches of the purported generic GA.
“This extensive analysis indicates, in my view, a concerning lack of consistency and predictability in the purported generic GA's effect on key elements of the murine immune system. Furthermore, variability seen in the expression of certain genes, from one batch of the purported generic GA to another, raises the possibility that patients may not receive the same treatment effect with each dose,” said Dr.
The full data analysis can be found by visiting PLOS ONE.
ABOUT THE STUDY
The study, co-authored by investigators from both
According to the
COPAXONE® (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, the most common form of MS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. See additional important information at http://copaxone.com/pdfs/PrescribingInformation.aspx. For hardcopy releases, please see enclosed full prescribing information. COPAXONE® is now approved in more than 50 countries worldwide, including
Important Safety Information about COPAXONE®
Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, patients should call the emergency phone number in their area. Patients should call their doctor right away if they develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, patients should not give themselves any more injections until their doctor tells them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they have while taking COPAXONE®.
Patients are encouraged to report negative side effects of prescription drugs to the
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our innovative R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and