Synthon announces today that it has recently submitted an Abbreviated New Drug Application (ANDA) for glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes to the FDA.
This is an important milestone for Synthon towards introduction of a generic version of this multiple sclerosis (MS) drug on the US market. The reference listed drug for glatiramer acetate is Copaxone*, indicated for reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis (RRMS).
Multiple sclerosis is a chronic, unpredictable, and progressive disease of the central nervous system that causes inflammation and destruction of the myelin sheath - the protective layer that surrounds the body's nerve fibers. This destruction may result in cognitive impairment, physical disability, and fatigue. According to the National MS Society, MS affects about 400,000 people in the U.S. and more than 2.5 million people worldwide. RRMS affects about 85 percent of the MS population. RRMS is characterized by clearly defined flare-ups followed by periods of partial or complete recovery or remission.
Synthon’s CEO Rudy Mareel stated: “Synthon is actively implementing its specialty pharmaceuticals strategy. We are doing this by focusing drug development R&D increasingly within identified therapeutic areas. Multiple sclerosis is one area where we are showing early success. The availability of a generic of Copaxone means that MS treatments, with a current high cost of around 40,000 dollar a year per US patient, will become more affordable and it will allow more patients around the world to access this drug.”
Given its structure as a complex mixture of polypeptide chains of various lengths and sequences, there are significant technical challenges involved in characterizing Copaxone and in manufacturing an equivalent version. Synthon believes that it has sufficiently characterized glatiramer acetate to develop a generic version of Copaxone. Copaxone sales in the US are expected to reach $2.4 billion in 2011.
* Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Synthon, with headquarters in Nijmegen, the Netherlands, is an international fast-growing pharmaceutical company and a leader in the field of generic medicines. Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of Multiple Sclerosis and Oncology. Synthon employs about 1,400 staff at 11 sites worldwide, and in 2010 it recorded a turnover of EUR 230 million. For more information, go to www.synthon.com.