Synthon intends to defend vigorously.
As announced on December 13, 2011 Synthon has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes. 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).
April 3, Teva Pharmaceuticals USA and Yeda Research and Development Co. Ltd. (Teva) have filed a lawsuit in both the United States District Court for the Southern District of New York (case number 12-cv-2556) and the United States District Court for the Eastern District of North Carolina Western Division (case number 12-cv-00179) asserting that Synthon’s filing of its ANDA infringes certain patents.
The Teva lawsuit alleges infringement of United States patents 5,981,589; 6,054,430; 6,342,476; 6,362,161; 6,620,847; 6,939,539; and 7,199,098, all of which are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) for Copaxone® and 5,800,808 and 6,048,898 (“process patents”).
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. Copaxone® sales in the United States are expected to reach $2.4 billion in 2012.
Synthon’s CEO Rudy Mareel stated: “Synthon intends to defend vigorously against Teva’s patent infringement claims. We are committed to developing a generic alternative to Copaxone® to make this RRMS treatment, with a current high cost of around $40,000 per U.S. patient per year, more affordable and accessible for patients in the U.S. and around the world.”
*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 auto-immune disease, multiple sclerosis and oncology. Our products are currently approved by regulatory agencies in over 80 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,400 staff at 11 sites worldwide, and in 2011 it recorded a turnover of EUR 260 million.