Copaxone (Glatiramer Acetate)
Glatiramer acetate with the trade name “Copaxone” is a combination of four naturally amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine that affect the immune system. This unique multiple sclerosis immunomodulatory is the first innovative drug that is developed in Israel. It is the first and only non-interferon agent for treating multiple sclerosis (MS); it will not cure MS; it can just make relapses occur less often by preventing the immune system from attacking the nerves in the brain and spinal cord. Copaxone injection site reactions like pain, redness, soreness, itching, swelling, or a hard lump and nausea are the most common Copaxone side effects. FDA approved two generic Copaxone.
Background of Copaxone
Michael Sela, Ruth Arnon, and Dvora Teitelbaum at the Weizmann Institute of Science in Rehovot, Israel discovered Glatiramer acetate. It was approved in the U.S. in 1997
In 2000: It was approved for marketing in the U.K.
In 2015: The patent on the chemical drug expired
Mechanism of action
The cause of MS is unknown. In MS, the immune system of the body reacts against the ‘insulation’ surrounding nerve fibers, its own myelin. Meanwhile, this disease affects the brain and spinal cord. Given its resemblance to myelin basic protein, Copaxone may act as a decoy and diverting an autoimmune response against myelin.
In relapsing forms of MS, people can have ‘exacerbations’ from time to time like blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function followed by periods of recovery. Although the exact mechanism of how Copaxone works in MS is not known, it is believed that it works by changing the immune processes that are thought to be responsible for the disease.
Copaxone 40 mg/mL is indicated
- for the management of relapsing forms of Multiple Sclerosis (MS). It is effective in reducing the number of relapses in patients with relapsing-remitting
- for patients, have experienced symptoms for the first time and have MRI changes that indicate a high risk for the development of MS.
Copaxone in the Market
Copaxone is the first nonsteroidal, non-interferon-based therapy for MS that has been launched in the USA. It has been approved for marketing in numerous countries worldwide, including the United States, Israel, Canada, and 24 European Union countries. Iran is trying to proceed with domestic manufacture of Glatiramer Acetate.
Copaxone licensed to Teva Pharmaceuticals Ltd, the main medicine wholesaler for hospitals. On the list of the top 20 pharmaceutical companies, Teva Pharmaceutical Industries Ltd., headquartered in Israel, is one of the largest generic pharmaceutical companies and also a drug exporter for hospitals in the world.
Teva announced that global in-market sales of Copaxone® reached a record $291 million in the second quarter of 2005; Sales in the second quarter 2005 increased 29% over the second quarter 2004 in the US and outside the US sales increased by 28% over the comparable quarter of 2004. IMS believed that Copaxone® continued to hold its position as the market leader in both total and new prescriptions, reaching a TRx share of 32.7% in June 2005. It also continued to be the leader in the last 10 and 19 weeks for TRx and NRx, respectively. Israel Makov, President and CEO of Teva believed that these record sales are a reflection of Copaxone’s unmatched long-term efficacy and its unique ability to address both the inflammatory and neurodegenerative aspects of MS. He considered them as the major driver in Copaxone®’s continuous global growth and leadership in the US. Copaxone price is around $7,436 for a supply of 30 milliliters.
A generic version of the original Teva 20 mg formulation that requires daily injection is Glatopa that Novartis subsidiary Sandoz has marketed since 2015. Sandoz received FDA approval for their generic version in 2018. In October 2017, the FDA approved another generic version that NATCO Pharma manufactures in India, and Dutch firm, Mylan, imports and sells by. Dano Health as a pharmaceutical supply chain for hospitals can supply Copaxone for all hospitals and health care clinics.