In November 2011, Synthon filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for a once daily 20mg/ml formulation of glatiramer acetate. In early 2014, Synthon filed an ANDA for a three times a week 40mg/ml formulation of glatiramer acetate with the FDA. In addition, Synthon believes its glatiramer acetate 40mg/ml filing may be eligible for 180 days of shared marketing exclusivity under the provisions of the Hatch-Waxman Act.
"Neurologic diseases such as multiple sclerosis represent some of the most debilitating illnesses of our time," said Diem Nguyen, regional president of North America, Pfizer Global Established Pharma business. "Pfizer's significant experience in successfully bringing meaningful medicines to market together with Synthon's scientific expertise in neurodegenerative diseases will enable us to leverage our core capabilities in support of improving patient health in the United States."
Under the terms of the agreement, Pfizer will have exclusive rights to commercialize both dosage formulations of Synthon's glatiramer acetate in the United States. Synthon is responsible for the clinical development, manufacture and supply of glatiramer acetate. Pfizer is solely responsible for the commercialization of glatiramer acetate in the United States. Financial terms of the agreement were not disclosed.
"We are very pleased to partner with Pfizer on the introduction of glatiramer acetate to patients and healthcare providers in the United States," said Jacques Lemmens, chief executive officer of Synthon. "Our partnership will ensure the rapid introduction of a high quality product through Pfizer's well-established presence in the United States, which in turn may result in savings on an important MS medication for patients and payors."
A Phase III Glatiramer Acetate clinical trial To assess Equivalence with Copaxone® (GATE) was set up following Scientific Advice received from the European Medicines Agency (EMA) with the aim to show equivalence of Synthon's glatiramer acetate (Synthon GTR) with Teva's Copaxone® in a well-controlled 3-arm double-blind equivalence study. The open-label part of the study further aimed to provide 2-year efficacy, safety and tolerability data on Synthon's generic glatiramer acetate and to show safety of switching from Copaxone® to Synthon's generic. The large-scale, multicenter study consisted of a nine-month double-blind efficacy comparison followed by a 15-month open-label extension and was executed in RRMS patients in Europe (including Russia, Ukraine and Belarus), Mexico, South Africa and the United States.
About Multiple Sclerosis
Multiple sclerosis (MS) is an unpredictable, often disabling disease of the central nervous system which interrupts the flow of information within the brain, and between the brain and body. Signs and symptoms vary widely, depending upon the amount of damage and which nerves are affected. Symptoms range from numbness and tingling to blindness and paralysis. These problems may come and go or persist and worsen over time. Relapsing Remitting Multiple Sclerosis (RRMS) is the most common form of MS characterized by clear episodes of inflammatory activity known as relapses, followed by remission. RRMS affects approximately 85 percent of newly diagnosed patients.
According to the National Multiple Sclerosis Society, most people with MS are diagnosed between the ages of 20 years and 50 years, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide. In the United States, the number of people with MS is estimated to be about 400,000.
Synthon, with headquarters in Nijmegen, the Netherlands, is an international pharmaceutical company and a leader in the field of complex generic medicines. The company started its biopharmaceutical franchise in 2007 and is building a promising portfolio of next generation medicines. Synthon is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of auto-immune diseases and oncology. Synthon products are currently approved by regulatory agencies in over 90 countries worldwide and marketed through strategic partnerships and - in dedicated areas - through direct sales. Synthon employs about 1,500 staff worldwide, and in 2014 it recorded a turnover of EUR 218 million.
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